Tagged Clinical Trials

Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says

Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says

The agency’s new guidance will speed the development of vaccines that protect against more contagious variants of the coronavirus.

Nurses preparing doses of the Pfizer vaccine at a community center in Rohnert Park, Calif., last month.
Nurses preparing doses of the Pfizer vaccine at a community center in Rohnert Park, Calif., last month.Credit…Jim Wilson/The New York Times
  • Feb. 22, 2021, 5:32 p.m. ET

The Food and Drug Administration said on Monday that vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants.

The recommendations, which call for small trials more like those required for annual flu vaccines, would greatly accelerate the review process at a time when scientists are increasingly anxious about how the variants might slow or reverse progress made against the virus.

The guidance was part of a slate of new documents the agency released on Monday, including others addressing how antibody treatments and diagnostic tests might need to be retooled to respond to the virus variants.

Together, they amounted to the federal government’s most detailed acknowledgment of the threat the variants pose to existing vaccines, treatments and tests for the coronavirus, and came weeks after the F.D.A.’s acting commissioner, Dr. Janet Woodcock, said the agency was developing a plan.

“The emergence of the virus variants raises new concerns about the performance of these products,” Dr. Woodcock said in a statement Monday. “We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

Most of the vaccine manufacturers with authorized vaccines or candidates in late-stage trials have already announced plans to adjust their products to address the vaccine variants. The Moderna and Pfizer-BioNTech vaccines use mRNA technology that the companies have said can be used to alter the existing vaccines within six weeks, although testing and manufacturing would take longer.

Moderna has already begun developing a new version of its vaccine that could be used as a booster shot against a virus variant that originated in South Africa, known as B.1.351, which seems to dampen the effectiveness of the existing vaccines.

A fast-spreading coronavirus variant first observed in Britain has also gained a worrisome mutation that could make it harder to control with vaccines. That variant with the mutation was found in the United States last week.

Still, the guidance did not appear to be written with the assumption that new vaccines were imminent, or would be needed at all. Despite the recent indications that some variants — and particularly B.1.351 — make the currently authorized vaccines less effective, the shots still offer protection and appear to greatly reduce the severity of the disease, preventing hospitalizations and death.

Asked at a news briefing on Monday afternoon how much the variants would need to spread before updated vaccines were necessary, Dr. Woodcock did not give any specific criteria. “We need to anticipate this and work on it so that we have something in our back pocket before the threshold is upon us,” she said.

An updated Covid-19 vaccine can skip the monthslong process of a randomized clinical trial that would compare it with a placebo, the agency said. But a tweaked vaccine will still need to go undergo some testing. In trials proposed by the F.D.A., researchers will draw blood from a relatively small group of volunteers who have been given the adapted vaccine. Scientists will then observe what percentage of volunteers’ samples produce an immune response to the variants in the lab, and how large that response is. The vaccines will be judged acceptable if they produce an immune response that is relatively close to the one prompted by the original vaccines.

Dr. Peter Marks, the top vaccine regulator at the F.D.A., said at the news briefing that studies would include a “few hundred” people and last several months.

Volunteers will also be monitored carefully for side effects. The agency said the testing could be done in a single age group and then extrapolated to other age groups.

The guidance also encouraged the use of animal studies to support the case for modified vaccines, in case immune response studies come up with ambiguous conclusions.

The F.D.A. acknowledged that many questions remained unanswered, such as what type of data would trigger the need for an adapted vaccine and who would make that decision. The agency also noted that scientists had not yet determined the minimum level of antibodies in a vaccinated person’s blood that would protect someone from the virus.

Some other vaccines are regularly updated in a similar way. Because the influenza virus evolves rapidly from one year to the next, vaccine developers have to come up with new recipes annually.

The newly tweaked Covid-19 vaccines would be authorized under an amendment to the emergency authorization granted to the original vaccine, regulators said.

Some Teens Volunteer for Covid Vaccine Trials to Get Their Lives Back

To Get Their Lives Back, Teens Volunteer for Vaccine Trials

Immunizing teenagers is a critical part of slowing the pandemic and reaching herd immunity. But enrolling them in clinical trials poses challenges that are very different than wrangling adults.

In Houston, Isabelle King, 14, gets her second dose of the Moderna vaccine from Jallesse Flores, as her twin sister,  Alexandra, looks on.
In Houston, Isabelle King, 14, gets her second dose of the Moderna vaccine from Jallesse Flores, as her twin sister,  Alexandra, looks on.Credit…Brandon Thibodeaux for The New York Times

  • Feb. 16, 2021, 1:55 p.m. ET

To get out of ninth-grade science period one recent Friday, the King twins had an excuse that is so very 2021.

Alexandra and Isabelle, 14, had to miss class — including a test — because they were participating in an actual science experiment: a clinical trial of Moderna’s Covid-19 vaccine to evaluate whether the shot is effective and safe in children ages 12 through 17.

“In science we’re learning about, like, genetics and stuff like that,” said Alexandra during the monitoring period after they’d gotten their shots at a Houston clinic. “So maybe the teacher will say, ‘Oh, you really shouldn’t have to take the test, because you’re contributing to science already.’”

Teenagers contract the novel coronavirus almost twice as often as younger children but vaccines authorized in the United States are mostly for adults — Moderna’s for 18 and older, Pfizer’s for 16 and up. While teenagers don’t become severely ill from the virus as often as adults, research suggests that because they are often asymptomatic and casual about social distancing, they can be efficient spreaders — to one another as well as to adults like parents, grandparents and teachers. Although vaccinating educators will be an important factor in keeping schools open, vaccinating students will also be a key element.

Bottom line: If widespread immunity to the coronavirus is to be achieved, adolescents are critical links. They need a Covid vaccine that works for them.

But teenagers are harder than adults to enroll and keep in clinical trials. They are difficult to wrangle and not so great with compliance, which includes keeping a symptom diary and keeping appointments, as many as six a year, that include blood draws (for some, an instant deal breaker).

To reach students, some researchers have tapped school connections, local pediatricians and social media campaigns. While waiting for appointments in the vaccine research clinics, some teenagers, ignoring advice to keep their vaccine volunteering off of social media, have posted TikTok videos, which have inspired friends to sign up. But the adolescent Covid vaccine trials will be much smaller than the adult trials — two or three thousand subjects instead of 30,000.

“You want to enroll as many kids as necessary but as few as possible, to expose as few as possible,” said Dr. Robert W. Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center.

To enroll in a trial, children must give “assent,” a legally required, age-appropriate version of “consent.” But researchers must also obtain the parent’s consent or permission. Information sessions for each can be protracted and painstaking. Objection by either child or parent terminates the application.

“Parents may be willing to put themselves in a study but not their children,” said Dr. James Campbell, a pediatric infectious disease expert at the University of Maryland School of Medicine who conducts vaccine trials. “Their key role in life, as parents, is to keep their children safe and they may choose to wait until a vaccine is licensed rather than enroll their child in a trial.”

Often researchers give young subjects an additional caution. Because vaccine disinformation and online personal attacks are so widespread, youth volunteers should avoid discussing their role in the trial on social media.

Audrey, 14, and Sam, 12, brother and sister, are participating in the Pfizer trial in Cincinnati.
Audrey, 14, and Sam, 12, brother and sister, are participating in the Pfizer trial in Cincinnati.Credit…Maddie McGarvey for The New York Times

Although the novel coronavirus has had far less impact on children than older adults, some 2.2 million pediatric cases in the United States have been reported and about 280 children have died, according to the Centers for Disease Control and Prevention. About 2,060 children have contracted a dangerous rare condition related to the coronavirus called multisystem inflammatory syndrome, which can shut down the heart and other organs.

And like anenemy occupation, the pandemic has taken over most children’s lives — shutting down in-person school, sports, socializing. That has prompted some teenagers, who otherwise feel so powerless, to fight back by volunteering for vaccine trials.

Sam, 12, who entered the Pfizer trial at Cincinnati Children’s hospital, said he wanted to participate “because it would be helping science and beat the pandemic. And it was my way of saying thank you to the frontline workers who are keeping us healthy.”

His sister, Audrey, 14, who is also in the study, said, “I thought this would be a really good story I could tell my children and grandchildren — that I tried to help create the vaccine.”

“And I also thought it is important to have people of different ages and races represented,” added Audrey, who, like her brother, is Asian. (Their mother, Rachel, a nurse researcher who volunteered for a vaccine trial, asked that their last names be withheld for privacy reasons.)

Overall, the teen trials may be less diverse, because results from adult trials showed no discernible difference in outcome by race. And because the adult trials were so successful, up to two-thirds of teenagers may be offered the actual vaccine rather than a placebo.

Pfizer, whose trial is fully enrolled, expects results from its trials for children ages 12 through 15 in the first quarter of this year, which it will then submit to the Food and Drug Administration for review. Moderna is still recruiting for its adolescent trials, with data anticipated sometime this summer. Other companies expect to start adolescent trials soon. Shortly after, researchers will open trials for children as young as 5, most likely with more modest doses.

As in any medical trial, investigators are evenhanded when discussing risks and benefits. Rather than lecturing young subjects, Dr. Campbell, whose clinic will conduct a Moderna trial for younger children, engages them in conversation.

“Do you remember your tetanus shot? Tell me about it,” he might say. And then, “Here’s how this is similar and how it’s different.” He wants to make sure the teenager is actively involved in decision-making. “We always say, ‘Don’t do this for your parents.’ ”

Dr. Sarah Hasan, lead recruiter for DM Clinical Research, which oversees the Houston Fights Covid campaign and most of the city’s vaccine trials, said that information sessions for adolescents and adults differ strikingly. She has more fun with the teenagers.

“Usually adults will skim the form, ask a few questions and they’re done,” she said. “But kids ask way more questions than adults and they’re actually listening, which is pretty nice.”

“Of course,” she added, “they also want to know if the doses will turn them into zombies.”

During adult trials, when participants were leery and results unknown, no-shows for appointments were common, Dr. Hasan said. But teenagers “come on time and are being super-compliant.”

Another issue in enrollment is compensation. Researchers typically offer volunteers money to cover time and travel expenses but the amount cannot be substantial enough to seem like an inducement. The going rate is about $15 an hour. The Cincinnati Pfizer trial compensates parents too, reasoning that they contribute time and money, as unofficial chauffeurs for the young subjects.

In Houston, the King sisters were already fantasizing about how they would spend the money.

Alexandra’s impulses were immediately generous. Now she could buy presents for others that her father typically paid for. “It’ll definitely be something nice to do, like, I earned it by getting a shot in the arm to help people. And now at least I can buy Christmas gifts for my mom,” she said.

Jonah Proctor, 15, awaits his shot at a Covid vaccine trial site in Houston.Credit…Brandon Thibodeaux for The New York Times

Her sister Isabelle hastily chimed in that, of course, she too would use the money for something selfless. Then she did allow, “Well, my closet could use an update.”

This summer, Monica Mitchell, a community health educator who works for Cincinnati Children’s, participated in a Pfizer vaccine trial. Her daughter Melanie, a high school junior, was deeply curious, but at that point, volunteers had to be at least 16 years old. On the day she turned 16, Melanie called to enroll.

Both mother and daughter have become ambassadors for the vaccine. “Someone said to me, ‘You’re doing the white man’s work,’ ” recounted Melanie, who is Black. “And I said, ‘No, it’s the opposite. I’m doing the work for my people.’ ”

Dr. Mitchell, who is also a pediatric psychologist and researcher, got some blowback for allowing her daughter to enter a vaccine trial. “Some relatives asked, “‘Why would you do that?’ But at least they understand that Melanie is fairly independent and they know she made her own decision,” Dr. Mitchell said.

Like most trial volunteers, children worry about side effects. Sure enough, after Sam got the second dose from Cincinnati Children’s hospital, he had a rough go of it.

In the middle of the night he woke with a throbbing headache. Then chills, a low-grade fever, muscle aches.

“He looked miserable,” said his mother, Rachel. “It’s one thing to talk theoretically about side effects but it was hard as a mom to see him feeling really bad.”

She felt guilty for having encouraged him to participate. “I’m so sorry,” she said.

Sam was mystified by her reaction. “I’m so happy,” he replied. “This means I got the real thing!”

Audrey, his sister, felt fine after her dose. “I’m jealous,” she said.

Covid Vaccines for Kids Are Coming, but Not for Many Months

Covid Vaccines for Kids Are Coming, but Not for Many Months

Pfizer and Moderna are testing their vaccines on children 12 and older and hope to have results by the summer.

A 15-year-old participating in Moderna’s teen Covid vaccine trial received a shot in Houston this month.
A 15-year-old participating in Moderna’s teen Covid vaccine trial received a shot in Houston this month.Credit…Brandon Thibodeaux for The New York Times
Apoorva Mandavilli

  • Feb. 12, 2021, 5:00 a.m. ET

As adults at high risk for Covid-19 line up to be immunized against the coronavirus, many parents want to know: When will my child get a vaccine?

The short answer: Not before late summer.

Pfizer and Moderna have enrolled children 12 and older in clinical trials of their vaccines and hope to have results by the summer. Depending on how the vaccines perform in that age group, the companies may then test them in younger children. The Food and Drug Administration usually takes a few weeks to review data from a clinical trial and authorize a vaccine.

Three other companies — Johnson & Johnson, Novavax and AstraZeneca — also plan to test their vaccines in children, but are further behind.

When researchers test drugs or vaccines in adults first, they typically then move down the age brackets, watching for any changes in the effective dose and for unexpected side effects.

“It would be pretty unusual to start going down into children at an early stage,” said Dr. Emily Erbelding, an infectious diseases physician at the National Institutes of Health who oversees testing of Covid-19 vaccines in special populations.

Some vaccines — those that protect against pneumococcal or meningococcal bacteria or rotavirus, for example — were tested in children first because they prevent pediatric diseases. But it made sense for coronavirus vaccines to be first tested in and authorized for adults because the risk of severe illness and death from Covid-19 increases sharply with age, said Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s vaccine advisory panel.

“We’re trying to save lives, keep people out of the I.C.U., keep them from dying,” Dr. Offit said. That means prioritizing vaccines for the oldest people and for those with underlying conditions.

People younger than 21 account for about one-quarter of the population in the United States, but they make up less than 1 percent of deaths from Covid-19. Still, about 2 percent of children who get Covid-19 require hospital care, and at least 227 children in the United States have died of the disease.

“It is a significant disease in children, just not necessarily when you compare it to adults,” said Dr. Kristin Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York.

Children will also need to be vaccinated in order for the United States to approach herd immunity — that long-promised goal at which the pandemic slows to a halt because the virus runs out of people to infect.

Scientists have estimated that 70 to 90 percent of the population might need to be immunized against the coronavirus to reach herd immunity, especially with more contagious variants expected to circulate widely in the country.

“Not all adults can get the vaccine because there’s some reluctance, or there’s maybe even some vulnerable immune systems that just don’t respond,” Dr. Erbelding said. “I think we have to include children if we’re going to get to herd immunity.”

It will also be important to immunize children in racial and ethnic populations that are hit hardest by the pandemic, she added.

Abhinav, 12, a participant in the Pfizer vaccine trial at Cincinnati Children’s Hospital last month.
Abhinav, 12, a participant in the Pfizer vaccine trial at Cincinnati Children’s Hospital last month.Credit…Cincinnati Children’s Hospital

Pfizer and Moderna’s clinical trials in adults each enrolled about 50,000 participants. They had to be that large in order to show significant differences between the volunteers who received a vaccine and those who got a placebo. But because it is rarer for children to become seriously ill with Covid-19, that kind of trial design in children would not be feasible, because it would require many more participants to show an effect.

Instead, the companies will look at vaccinated children for signs of a strong immune response that would protect them from the coronavirus.

The Pfizer-BioNTech vaccine was authorized in December for anyone 16 and older. The company has continued its trial with younger volunteers, recruiting 2,259 adolescents from 12 to 15 years of age. Teenagers are roughly twice as likely to be infected with the coronavirus as younger children, according to the Centers for Disease Control and Prevention.

Results from that trial should be available by summer, said Keanna Ghazvini, a spokeswoman for Pfizer.

“Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” Ms. Ghazvini said. Those trials will most likely start later in the year, but the plans will be made final after the company has data from older children, she added.

Moderna’s vaccine, which was also authorized in December, is on a similar track for pediatric testing. In December, the company began testing adolescents ages 12 through 17, and plans to enroll 3,000 volunteers in this age group. The company expects results “around midyear 2021,” said Colleen Hussey, a spokeswoman for Moderna.

Based on the results, Moderna plans to assess the vaccine later this year in children between the ages of 6 months and 11 years.

Infants may have some antibodies at birth from vaccinated or infected mothers, but that maternal protection is unlikely to last through the first year of age. And with their relatively weak immune systems, babies might be particularly susceptible to infection if community transmission is high.

The trials will also assess the vaccine’s safety in children — and hopefully ease any fears that parents have. One-third of adults in the United States have said they do not plan to have their children immunized against the coronavirus, according to a recent poll conducted by Verywell Health.

Given the low risk of Covid-19 in children, some parents might be skeptical of the urgency to inoculate their children with a brand-new jab, Dr. Offit said. “For that reason, the vaccine would have to be held to a very high standard of safety,” he said.

More than 42 million people in the United States have been immunized so far, with few lasting side effects. And the F.D.A. has set up multiple systems to carefully monitor any serious reactions to the vaccine.

“They’re really looking at the data very, very closely,” Dr. Oliver said. “As a pediatrician and a mom, I have really good confidence that those systems work.”

Once a vaccine for children is available, schools can reintroduce extracurricular activities that involve close contact, like band practice, team sports and choir. But in the meantime, there is ample evidence that schools can reopen with other precautions in place, Dr. Oliver said.

“I don’t think we need to anticipate having a vaccine in order to open schools in the fall,” she said. “We should be planning now for opening schools.”

Dr. Oliver also urged parents to make sure children are immunized for other diseases. According to the C.D.C., orders for non-flu childhood vaccines through the Vaccines for Children Program are down approximately 10.3 million doses over all.

“Now’s the time to really catch up on missed doses of those vaccines,” she said. “Measles, HPV, tetanus boosters, pertussis boosters — all of that is really important.”

Could a Single Vaccine Work Against All Coronaviruses?

Could a Single Vaccine Work Against All Coronaviruses?

Scientists are working on a shot that could protect against Covid-19, its variants, certain seasonal colds — and the next coronavirus pandemic.

Tara Gallion, a licensed practical nurse, prepared to administer doses of the Moderna Covid vaccine in Mound Bayou, Miss., last month.
Tara Gallion, a licensed practical nurse, prepared to administer doses of the Moderna Covid vaccine in Mound Bayou, Miss., last month.Credit…Rory Doyle for The New York Times
Carl Zimmer

  • Feb. 9, 2021, 11:26 a.m. ET

The invention of Covid-19 vaccines will be remembered as a milestone in the history of medicine, creating in a matter of months what had before taken up to a decade. But Dr. Kayvon Modjarrad, the director of Emerging Infectious Diseases Branch at Walter Reed Army Institute of Research in Silver Springs, Md., isn’t satisfied.

“That’s not fast enough,” he said. More than 2.3 million people around the world have died, and many countries will not have full access to the vaccines for another year or two: “Fast — truly fast — is having it there on day one.”

There will be more coronavirus outbreaks in the future. Bats and other mammals are rife with strains and species of this abundant family of viruses. Some of these pathogens will inevitably spill over the species barrier and cause new pandemics. It’s only a matter of time.

Dr. Modjarrad is one of many scientists who for years have been calling for a different kind of vaccine: one that could work against all coronaviruses. Those calls went largely ignored until Covid-19 demonstrated just how disastrous coronaviruses can be.

Now researchers are starting to develop prototypes of a so-called pancoronavirus vaccine, with some promising, if early, results from experiments on animals. Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in San Diego, thinks scientists should join together in another large-scale vaccine-creation project immediately.

“We have to get a real work force to accelerate this, so we can have it this year,” he said. Dr. Topol and Dennis Burton, a Scripps immunologist, called for this project on broad coronavirus vaccines on Monday in the journal Nature.

After coronaviruses were first identified in the 1960s, they did not become a high priority for vaccine makers. For decades it seemed as if they only caused mild colds. But in 2002, a new coronavirus called SARS-CoV emerged, causing a deadly pneumonia called severe acute respiratory syndrome, or SARS. Scientists scrambled to make a vaccine for it.

Dr. Kayvon Modjarrad, director of emerging infectious diseases at the Walter Reed Army Institute, during a coronavirus briefing in March.
Dr. Kayvon Modjarrad, director of emerging infectious diseases at the Walter Reed Army Institute, during a coronavirus briefing in March.Credit…Yasin Ozturk/Anadolu Agency, via Getty Images

Since no one had made a coronavirus vaccine for humans before, there was a huge amount to learn about its biology. Eventually, researchers chose a target for immunity: a protein on the surface of the virus, called spike. Antibodies that stick to the spike can prevent the coronavirus from entering cells and stop an infection.

Public health officials in Asia and elsewhere did not wait for the invention of a SARS vaccine to get to work, however. Their quarantines and other efforts proved remarkably effective. In a matter of months, they wiped out SARS-CoV, with only 774 deaths along the way.

The danger of coronaviruses became even clearer in 2012, when a second species spilled over from bats, causing yet another deadly respiratory disease called MERS. Researchers started work on MERS vaccines. But some researchers wondered if making a new vaccine for each new coronavirus — what Dr. Modjarrad calls “the one bug, one drug approach” — was the smartest strategy. Wouldn’t it be better, they thought, if a single vaccine could work against SARS, MERS and any other coronavirus?

That idea went nowhere for years. MERS and SARS caused relatively few deaths, and were soon eclipsed by outbreaks of other viruses such as Ebola and Zika.

In 2016, Maria Elena Bottazzi, a virologist at Baylor College of Medicine, and her colleagues applied for support from the American government to develop a pancoronavirus vaccine, but did not receive it. “They said there’s no interest in pancorona,” Dr. Bottazzi recalled.

Her team even lost funding for developing a SARS vaccine after they showed that it worked in mice, was not toxic to human cells and could be manufactured at scale. A coronavirus that had disappeared from view simply wasn’t a top priority.

Without enough money to start clinical trials, the scientists stored their SARS vaccine in a freezer and moved on to other research. “It’s been a struggle,” Dr. Bottazzi said.

Dr. Matthew Memoli, a virologist at the National Institute of Allergy and Infectious Diseases, looks back at those decisions as an enormous blunder. “It’s a failure of our system of science,” he said. “Funders tend to chase after shiny objects.”

A transmission electron micrograph of the Middle East Respiratory Syndrome.Credit…NIAID

Three years later, a third dangerous coronavirus emerged: the SARS-CoV-2 strain that causes Covid-19. Although this virus has a much lower fatality rate than its cousins that cause SARS and MERS, it does a far better job of spreading from person to person, resulting in more than 106 million documented cases around the world and still climbing.

All the lessons that researchers had learned about coronaviruses helped them move quickly to make new vaccines for SARS-CoV-2. Dr. Bottazzi and her colleagues used the technology they had created to make SARS vaccines to make one for Covid-19, which is now in early clinical trials.

Other researchers used even newer methods to move faster. The German company BioNTech created a genetic molecule called messenger RNA that encoded the spike protein. Partnering with Pfizer, the companies received U.S. government authorization for their vaccine in just 11 months. The previous record for a vaccine, against chickenpox, was four years.

Although the Covid-19 pandemic is still far from over, a number of researchers are calling for preparations for the next deadly coronavirus.

“This has already happened three times,” said Daniel Hoft, a virologist at Saint Louis University. “It’s very likely going to happen again.”

Researchers at VBI vaccines, a Cambridge-based company, took a small step toward a pancoronavirus vaccine last summer. They created virus-like shells studded with spike proteins from the three coronaviruses that caused SARS, MERS and Covid-19.

When the researchers injected this three-spike vaccine into mice, the animals made antibodies that worked against all three coronaviruses. Intriguingly, some of those antibodies could also latch onto a fourth human coronavirus that causes seasonal colds — even though that virus’s spike proteins were not included in the vaccine. The scientists have made this data public but have not yet published it in a scientific journal.

David Anderson, VBI’s chief scientific officer, said it was not clear why the vaccine worked this way. One possibility is that an immune cell presented with several versions of a protein at once doesn’t make antibodies against just one. Instead, it makes a compromise antibody that works against them all.

“You’re educating it,” Dr. Anderson said, although he cautioned that this was speculation for now.

Last month, Pamela Bjorkman, a structural biologist at Caltech, and her colleagues published a more extensive experiment with a universal coronavirus vaccine in the journal Science. The researchers attached only the tips of spike proteins from eight different coronaviruses to a protein core, known as a nanoparticle. After injecting these nanoparticles into mice, the animals generated antibodies that could stick to all eight of the coronaviruses — and to four other coronaviruses that the scientists had not used in the vaccine.

Sarah Clarke, a lab technician at the Sequencing and Genomic Technologies Shared Resource at Duke University, working with positive coronavirus samples.Credit…Pete Kiehart for The New York Times

Dr. Modjarrad is leading a team at Walter Reed developing another vaccine based on a nanoparticle studded with protein fragments. They anticipate starting clinical trials on volunteers next month. Although the vaccine currently uses protein fragments only from SARS-CoV-2 spikes, Dr. Modjarrad and his colleagues are preparing to retool it as a pancoronavirus vaccine.

Dr. Hoft of Saint Louis University is working on a universal vaccine that does not rely on antibodies to the spike protein. Collaborating with Gritstone Oncology, a California-based biotech company, he has created a vaccine that prompts cells to make surface proteins that might alert the immune system as if a coronavirus — any coronavirus — were present. They are now preparing a clinical trial to see if it is effective against SARS-CoV-2.

“We are interested to develop maybe a third-generation vaccine, which would be on the shelf and ready for the future outbreak,” Dr. Hoft said.

Dr. Topol believes scientists should also explore another strategy: searching for pancoronavirus antibodies made by our own bodies during infections.

Researchers studying H.I.V. and other viruses have discovered, amid the billions of antibodies made during an infection, rare types that work against a huge range of related strains. It might be possible to create vaccines that coax the body to make abundant amounts of these broadly neutralizing antibodies.

Coronaviruses are similar enough to each other, Dr. Topol said, that it might not be that hard to build vaccines that make broadly neutralizing antibodies. “This is an easy family of viruses to take down,” he said.

The search for a pancoronavirus vaccine may take longer than Dr. Topol’s sunny expectations. But even if it takes a few years, it could help prepare the world for the next coronavirus that jumps the species barrier.

“I think we can have vaccines to prevent pandemics like this,” Dr. Memoli said. “None of us wants to go through this again. And we don’t want our children to go through this again, or our grandchildren, or our descendants 100 years from now.”

Which Covid Vaccine Should You Get? Experts Weigh the Effect Against Severe Disease

Which Covid Vaccine Should You Get? Experts Cite the Effect Against Severe Disease

Infectious disease doctors say getting a shot of the J&J vaccine, which has a lower efficacy against the virus than other vaccines, would still be well worthwhile.

Covid vaccinations in Santa Barbara County, Calif., this week.
Covid vaccinations in Santa Barbara County, Calif., this week.Credit…Daniel Dreifuss for The New York Times

  • Jan. 29, 2021, 5:32 p.m. ET

At first glance, the results reported on Friday from the long-awaited trial of Johnson & Johnson’s coronavirus vaccine might have seemed disappointing. Its overall efficacy — the ability to prevent moderate and severe disease — was reported at 72 percent in the United States, 66 percent in Latin American countries and 57 percent in South Africa.

Those figures appear far below the high bar set by Pfizer-BioNTech and Moderna, the first two vaccines authorized for emergency use in the United States, which reported overall efficacy from 94 to 95 percent.

Dr. Anthony S. Fauci, the nation’s leading infectious disease expert and now the lead medical adviser to President Biden on the coronavirus pandemic, acknowledged the striking difference at a briefing on Friday.

“If you woke up and you say, ‘Well, go to the door on the left and you get 94 or 95 percent, go to the door on the right and you get 72 percent,’ which door do you want to go to?” he asked.

But Dr. Fauci said that the more crucial measure was the ability to prevent severe disease, which translates to keeping people out of the hospital and preventing deaths. And that result, for Johnson & Johnson, was 85 percent in all of the countries where it was tested, including South Africa, where a rapidly spreading variant of the virus had shown some ability to elude vaccines.

More important than preventing “some aches and a sore throat,” Dr. Fauci said, is to fend off severe disease, especially in people with underlying conditions and in older adults, who are more likely to become seriously ill and to die from Covid-19.

“If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress in human suffering and death in this epidemic that we’re seeing, particularly now,” Dr. Fauci said, “as we well know, over the last several weeks, our health care system has been stressed by the number of people that require hospitalization, as well as intensive care.”

Dr. Francis Collins, director of the National Institutes of Health, compared the ability to prevent severe disease to the effects of flu shots, which do not always prevent influenza entirely but can make it less severe.

“The same thing seems to be applying here, in a circumstance where this variant is clearly making it a little tougher to get the most vigorous response that you would want to have,” Dr. Collins said. “But still, for severe disease, it’s looking really good.”

The Moderna vaccine also showed high efficacy, 100 percent, against severe disease. The Pfizer-BioNTech one appeared to as well, but the overall number of severe cases in the study was too small to be sure.

But researchers warn that trying to compare effectiveness between new studies and earlier ones may be misleading, because the virus is evolving quickly and to some extent the trials have studied different pathogens.

A participant in the Johnson & Johnson vaccine trial in Cape Town, South Africa, last month.
A participant in the Johnson & Johnson vaccine trial in Cape Town, South Africa, last month.Credit…Joao Silva/The New York Times

“You have to recognize that Pfizer and Moderna had an advantage,” Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said in an interview. “They did their clinical trials before the variant strains became very apparent. Johnson & Johnson was testing its vaccine not only against the standard strain but they had the variants.”

The best way to stop the spread of mutants and to prevent more new ones from emerging is to vaccinate as many people as quickly as possible, Dr. Fauci and other researchers say. Viruses cannot mutate unless they are replicating, and they cannot replicate unless they can get into cells. Keeping them out by immunizing people can shut down the process.

In addition to the Pfizer-BioNTech and Moderna vaccines already in use in the United States, three more may soon become available: those made by Novavax, Johnson & Johnson and AstraZeneca. AstraZeneca’s vaccine has already been authorized in Britain and other countries.

Globally, the Johnson & Johnson vaccine is expected to play an important role, especially in low and middle-income countries, because it works after just one shot, is relatively inexpensive and is easier to store and distribute than the vaccines made by Pfizer-BioNTech and Moderna since it does not share their stringent requirements for freezing and refrigerating.

People waiting to be vaccinated may wonder if they will be able to pick and choose among vaccines, and if they should hold out and wait until the one that looks best to them becomes available.


Covid-19 Vaccines ›


Answers to Your Vaccine Questions

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

Probably not. The answer depends on a number of factors, including the supply in your area at the time you’re vaccinated. Check your state health department website for more information about the vaccines available in your state. The Pfizer and Moderna vaccines are the only two vaccines currently approved, although a third vaccine from Johnson & Johnson is on the way.

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home.

If you have other questions about the coronavirus vaccine, please read our full F.A.Q.

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told CNN that if there was an abundant supply of the Pfizer-BioNTech and Moderna vaccines, they would be his first choices because of their higher overall efficacy.

But for now, there is not enough of those vaccines.

If he could not get either the Pfizer-BioNTech vaccine or the Moderna one, he would take the Johnson & Johnson shot, Dr. Offit said — as long as the data that the company will be presenting to the Food and Drug Administration looks as good as what the company reported on Friday.

He said Johnson & Johnson’s report of the reduction in severe disease was a powerful selling point.

“That’s what you want,” Dr. Offit said. “You want to stay out of the hospital, and stay out of the morgue.”

He noted that the company was also studying a two-shot regimen, which might raise its efficacy.

People who take the Johnson & Johnson vaccine should be able to safely receive a Pfizer-BioNTech or Moderna vaccine later if a booster shot is needed, he said.

Dr. Schaffner said he had just attended a meeting with other public health experts, and they had asked one another what they would tell their spouses or partners to do if they could get the Johnson & Johnson vaccine tomorrow, or had to wait three weeks for Pfizer-BioNTech’s or Moderna’s.

“All of us said, ‘Get the one tomorrow,’” Dr. Schaffner said. “The virus is bad. You’re risking three more weeks of exposure as opposed to getting protection tomorrow.”

He said Johnson & Johnson’s 85 percent efficacy against severe disease was a bit lower than those reported by Moderna and Pfizer-BioNTech, “but it’s still pretty darn high.”

It is not yet known whether it would be safe to take one type of vaccine now and then another later, Dr. Schaffner said, adding, “We haven’t studied this.”

Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants

Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants

The vaccine’s efficacy rate dropped from 72 percent in the United States to just 57 percent in South Africa, where a highly contagious variant is driving most cases.

A dose of Johnson & Johnson’s vaccine candidate was prepared at the Rocky Mountain Regional VA Medical Center in Aurora, Colo., last month.
A dose of Johnson & Johnson’s vaccine candidate was prepared at the Rocky Mountain Regional VA Medical Center in Aurora, Colo., last month.Credit…Michael Ciaglo/Getty Images
  • Jan. 29, 2021, 8:00 a.m. ET

Johnson & Johnson announced on Friday that its one-dose coronavirus vaccine provided strong protection against Covid-19, potentially offering the United States a third powerful tool in a desperate race against a worldwide rise in virus mutations.

But the results came with a significant cautionary note: The vaccine’s efficacy rate dropped from 72 percent in the United States to 57 percent in South Africa, where a highly contagious variant is driving most cases. Studies suggest that this variant also blunts the effectiveness of Covid vaccines made by Pfizer-BioNTech, Moderna and Novavax. The variant has spread to at least 31 countries, including the United States, where two cases were documented this week.

Johnson & Johnson said that it planned to apply for emergency authorization of the vaccine from the Food and Drug Administration as soon as next week, putting it on track to receive clearance later in February.

“This is the pandemic vaccine that can make a difference with a single dose,” said Dr. Paul Stoffels, the chief scientific officer of Johnson & Johnson.

The company’s announcement comes as the Biden administration is pushing to immunize Americans faster even with a tight vaccine supply. White House officials have been counting on Johnson & Johnson’s vaccine to ease the shortfall. But the company may only have about seven million doses ready when the F.D.A. decides whether to authorize it, according to federal health officials familiar with its production, and about 30 million doses by early April.

The variant from South Africa, known as B.1.351, could make things even worse for the vaccine push. Given the speed at which the variant swept through that country, it is conceivable that by April it could make up a large fraction of infections in the United States. That would undermine the effectiveness of available vaccines.

The fact that four vaccines backed by the federal government seem to be less effective against the B.1.351 variant has unsettled federal officials and vaccine experts alike. Facing this uncertainty, many researchers said it was imperative to get as many people vaccinated as possible — quickly. Lowering the rate of infection could thwart the contagious variants while they are still rare, and prevent other viruses from gaining new mutations that could cause more trouble.

“If ever there was reason to vaccinate as many people as expeditiously as we possibly can with the vaccine that we have right now, now is the time,” Dr. Anthony S. Fauci, the government’s top infectious disease expert, said in an interview. “Because the less people that get infected, the less chance you’re going to give this particular mutant a chance to become dominant.”

As the United States scrambles to get enough vaccines, the country is turning into something of an evolutionary experiment. The B.1.351 variant is one of several that have arrived in the country or originated here, all with the ability to spread faster than other variants.

“The pandemic is a lot more complicated now than it was a couple months ago,” said Dr. Dan Barouch, a virologist at Beth Israel Medical Center in Boston.

Vaughan Cooper, an evolutionary biologist at the University of Pittsburgh, said that all the new variants were likely evolving quietly for months before bursting on the scene. “I think we’re going to see many stories like this,” he said.

Federal regulators are also still waiting on data from Johnson & Johnson’s new manufacturing facility in Baltimore that prove it can mass-produce the vaccine. The company is counting on that factory to help reach its contractual pledge to the federal government of 100 million doses by the end of June.

If Johnson & Johnson can deliver vaccines quickly enough to the United States, it might be able to help drive down cases before variants make things worse. Since the vaccine requires only a single shot — unlike the Moderna and Pfizer-BioNTech vaccines, which require two — that delivery would translate into full coverage for 100 million people.

Johnson & Johnson’s vaccine has another advantage that might help speed up the rollout. It can stay viable in a refrigerator for three months, while the two authorized vaccines have to be kept frozen. That gives the company an edge not just in reaching more isolated parts of the United States, but in getting the vaccine to remote areas of the world that could otherwise seed more aggressive mutants.

“If you talk about the potential impact on the developing world, I believe it’s much more relevant than here,” Dr. Fauci said.

But vaccine makers also have to prepare for the B.1.351 variant or another one surging to dominance and demanding new vaccines. “You’ve got to be nimble enough to be able to adapt by upgrading our vaccines that match the dominant strain,” Dr. Fauci said.

Exactly when to make that switch will be a difficult decision, because the viruses are spreading unpredictably, and manufacturing new doses will be a huge undertaking.

“The implications of that are big. You would not take that choice lightly,” said John D. Grabenstein, an epidemiologist with the Immunization Action Coalition, a nonprofit organization that disseminates information about vaccines. “It’s not doomsday. It’s just that we are going to need a bigger boat.”

Johnson & Johnson’s announcement came one day after Novavax said an early analysis of its 15,000-person trial in Britain had revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent.

Johnson & Johnson presented only a summary of findings of its clinical trial. The vaccine was 85 percent effective in preventing severe disease in all three regions where the trial was run: the United States, Latin America and South Africa. After 28 days, none of the vaccinated participants who developed Covid-19 had to be hospitalized.

The company reported that the vaccine’s protective effect seems to increase with time. But without long-term data on immunity, scientists and regulators do not yet know whether the vaccine’s efficacy peaks at some point before dropping.

Dr. Stoffels said the company was still waiting for more data on whether the vaccine can protect against asymptomatic infection.


Covid-19 Vaccines ›


Answers to Your Vaccine Questions

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

Probably not. The answer depends on a number of factors, including the supply in your area at the time you’re vaccinated. Check your state health department website for more information about the vaccines available in your state. The Pfizer and Moderna vaccines are the only two vaccines currently approved, although a third vaccine from Johnson & Johnson is on the way.

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home.

If you have other questions about the coronavirus vaccine, please read our full F.A.Q.

The company is preparing a lengthy briefing document it will submit to the F.D.A. in its application for authorization. The agency’s scientists will review the raw data from the trial and present their own analysis.

Unlike the messenger RNA vaccines made by Pfizer-BioNTech and Moderna, Johnson & Johnson uses an adenovirus, which normally causes the common cold. While adenovirus-based vaccines have been investigated for some three decades, they have yet to be licensed for use in the United States.

Johnson & Johnson’s Ebola vaccine became the first approved adenovirus-based vaccine for any disease when European regulators gave it the green light last July. Astra-Zeneca and the University of Oxford used a different adenovirus for their coronavirus vaccine, which is now authorized in Britain and other countries. Russian scientists created their Sputnik V vaccine from adenoviruses as well.

Johnson & Johnson received $456 million from Operation Warp Speed to support its research. In July, the government agreed to purchase 100 million doses for $1 billion if it proved safe and effective.

That same month, the company moved into clinical trials, which found that a single shot produced a strong immune response, consistent with experiments done on monkeys. Johnson & Johnson began the final “Phase 3” trial in September, again using a single dose. It recruited volunteers in the United States, South Africa and Latin America.

Half of the volunteers received the vaccine, and half received a placebo. The company then had to wait. Only when enough people in the trial got Covid-19 would an independent board of advisers look at the results to see how many sick volunteers were vaccinated — a process known as unblinding.

Late last year, surges of coronavirus infections accelerated the trial toward unblinding. In December, Johnson & Johnson decided it would not need to recruit 60,000 volunteers as it originally planned. It capped the trial at 45,000.

Like other vaccine developers, Johnson & Johnson was required by the F.D.A. to also record information about adverse events experienced by the volunteers for the first few months after vaccination.

Dr. Barouch, who led the team that designed the vaccine and tested it on animals last year, had to wait for months for the unblinding. “I’m thinking a lot about it,” he said in a Jan. 11 interview. “But, no, I don’t have champagne ready to go.”

After he learned the results, Dr. Barouch said he was delighted. “I think this vaccine will have a public health benefit throughout the world,” he said.

Johnson & Johnson is also moving forward with other trials of the vaccine to see how it can be improved. In December it began a trial with two doses. Dr. Fauci was optimistic that people who get a so-called prime boost may enjoy even more protection.

“If they get a prime boost, it’s entirely conceivable that they can get up to 90-plus percent,” he said.

In addition, Dr. Stoffels said that Johnson & Johnson was tailoring a version of its vaccine with a protein patterned after the B.1.351 variant. It could potentially deploy it in countries where that version of the virus was a threat.

“Pretty much all vaccine developers now are having that conversation,” said Dr. Peter J. Hotez, a vaccine expert with the Baylor School of Medicine and the creator of a different coronavirus vaccine.

Pregnant Women Get Conflicting Advice on Covid-19 Vaccines

The W.H.O. and the C.D.C. provide differing views, and experts partly blame a lack of data because expectant mothers have been excluded from clinical trials.

Novavax’s Vaccine Works Well — Except on Variant First Found in South Africa

Novavax’s Vaccine Works Well — Except on Variant First Found in South Africa

An early analysis in Britain found that the vaccine had an efficacy rate of nearly 90 percent. But in a small South Africa trial, the efficacy rate dropped to just under 50 percent.

A patient participating in Novavax’s late-stage vaccine trial at Howard University in Washington this month.
A patient participating in Novavax’s late-stage vaccine trial at Howard University in Washington this month.Credit…Kenny Holston for The New York Times
  • Jan. 28, 2021, 4:05 p.m. ET

Novavax, a little-known company supported by the U.S. federal government’s Operation Warp Speed, said for the first time on Thursday that its Covid-19 vaccine offered robust protection against the virus. But it also found that the vaccine is not as effective against the fast-spreading variant first discovered in South Africa, another setback in the global race to end a pandemic that has already killed more than 2.1 million people.

The news was problematic for the United States, which hours earlier reported its first known cases of the contagious variant in two unrelated people in South Carolina. And it came just days after Moderna and Pfizer said that their vaccines were also less effective against the same variant.

Novavax, which makes one of six vaccine candidates supported by Operation Warp Speed last summer, has been running trials in Britain, South Africa, the United States and Mexico. It said Thursday that an early analysis of its 15,000-person trial in Britain revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent. Almost all the cases that scientists have analyzed there so far were caused by the variant, known as B.1.351. The data also showed that many trial participants were infected with the variant even after they had already had Covid.

“We have the first trial — we are the first to conduct an efficacy trial — in the face of a changing virus,” said Stanley Erck, the president and chief executive of Novavax. He said that researchers expected the variants could change the trial results, but “the amount of change has been a bit of a surprise to everyone.”

The South Africa trial was relatively small — with just 4,400 volunteers — and was not designed to come up with a precise estimate of how much protection the vaccine provides. Still, the results were striking enough that the company said it would soon begin testing a new vaccine tailored to protect against the variant from South Africa. “You’re going to have to make new vaccines,” Mr. Erck said.

While the Pfizer and Moderna vaccines rely on a newer mRNA technology that has not been used in previous vaccines, Novavax’s candidate employs an older, more established method that relies on injecting coronavirus proteins to provoke an immune response.

The fact that three vaccines all appeared to show lowered effectiveness against the variant from South Africa is not encouraging, and the results Novavax announced Thursday were the first to occur outside of a laboratory, testing how well a vaccine worked in people infected with a new variant. Johnson & Johnson is also on the cusp of announcing results of its Covid-19 vaccine trials, and has also tested its candidate in South Africa.

The announcement from Novavax raises the stakes for Johnson & Johnson. The company was expected to announce its results as early as last weekend, and the delay has triggered speculation among scientists that the firm has also discovered that its vaccine worked less well in South African trial volunteers who were infected with the variant. In an earnings call on Tuesday, Alex Gorsky, the chief executive officer of the company, said they were looking forward to sharing results from their late-stage trial by early next week.

The emergence of several highly contagious variants has complicated efforts to bring the pandemic under control, leading world leaders to shut down travel to places like Britain and South Africa even as the variants already appear to have circled the globe. In the United States, researchers have warned that the variant first identified in Britain, which is believed to be more infectious, could become the dominant form of the virus in this country by March.

A volunteer in Novavax’s South Africa trial was seen by a doctor last month before receiving an injection.
A volunteer in Novavax’s South Africa trial was seen by a doctor last month before receiving an injection.Credit…Joao Silva/The New York Times

The United States is well behind other countries in testing for such variants, and the one from South Africa has been found in about 30 countries.

But experts have also said there are reasons for optimism, noting that the vaccines remain effective. The best way to combat contagious new variants is to continue vaccination and other public health measures, which will slow the virus’s ability to infect new people and mutate further. Drug makers could update their vaccines and offer new shots at regular intervals, similar to the flu vaccine.


Covid-19 Vaccines ›


Answers to Your Vaccine Questions

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

Probably not. The answer depends on a number of factors, including the supply in your area at the time you’re vaccinated. Check your state health department website for more information about the vaccines available in your state. The Pfizer and Moderna vaccines are the only two vaccines currently approved, although a third vaccine from Johnson & Johnson is on the way.

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home.

If you have other questions about the coronavirus vaccine, please read our full F.A.Q.

Novavax’s trial in Britain tested how many volunteers developed symptoms of Covid-19 one week after receiving a second dose. The company said Thursday that its initial analysis showed that out of 62 participants who developed the illness, 56 had received a placebo and 6 had gotten the vaccine. The newer, more contagious variant first identified in Britain was found to have caused about 50 percent of the cases in the trial, Novavax said.

If those results were to bear out in the larger clinical trial in the United States and Mexico, which has enrolled about 16,000 out of a goal of 30,000 people, then it would put the vaccine on par with the Moderna and Pfizer-BioNTech vaccines, which were shown to be about 95 percent effective.

But the news in South Africa was not as encouraging. Novavax’s smaller trial found the vaccine to have a 49.4 percent efficacy overall. (The company reported that about 6 percent of the trial’s participants were positive for H.I.V., and for those who were not H.I.V. positive, the vaccine had a 60 percent efficacy.) The company said the trial began recording cases of Covid-19 from September through the middle of this month, when the more contagious variant was widely circulating. Novavax said 44 trial participants developed Covid-19, and it sequenced the genetic lineage of 27 cases. Of those, 25 cases were caused by the more contagious version of the virus.

The company also said that about one-third of the trial participants in South Africa had previously developed Covid-19 after being infected by the original form of the virus, and that their results showed those previous infections did not protect them against the new variant. The company said its vaccine did provide some protection for those who had previously contracted the disease, but did not include this group in its analysis.

Novavax began working on a new version of the vaccine this month to address more contagious variants, which could serve either as a booster shot or which could be given at the same time as their original vaccine.

The B.1.351 variant first came to the attention of scientists in December. It contains a number of mutations, including some that change the shape of the surface of the virus and weaken the effectiveness of vaccines.

Looking back at older samples, South African scientists found the first evidence of B.1.351 dating back to October. But by December, it had swept across the country, becoming the dominant lineage of the coronavirus in many regions.

That alone would make B.1.351 a worrying development. In Britain, researchers found another fast-spreading variant known as B.1.1.7. In Brazil and California, other scientists have found variants that may be more contagious than previous forms of the coronavirus.

Covid Vaccine During Pregnancy? Even Doctors Struggle With This Question

Doctors

I’m a Pregnant Doctor. Should I Get the Covid Vaccine?

A doctor struggles with the lack of data surrounding the Covid-19 vaccine and pregnancy.

Credit…Nam Y. Huh/Associated Press

  • Dec. 22, 2020, 5:00 a.m. ET

The morning after the Food and Drug Administration approved the emergency use authorization of the first coronavirus vaccine, I awoke to a message from my hospital asking me to sign up for an appointment to get vaccinated.

It brought tears to my eyes. As a primary care doctor, I haven’t exactly been on the front lines of the Covid-19 fight, but it’s upended my life and the lives of my patients. With the vaccine’s approval — and now a second one — we finally have an end in sight. Within hours, my colleagues were all texting each other, abuzz with the excitement of scheduling their vaccine appointments.

But I quickly learned I have an impossible choice ahead of me.

I am pregnant, and all of the clinical trials on Covid-19 vaccines excluded pregnant people. This is no surprise: pregnant people are frequently left out of clinical research because of the complexity of pregnancy, including concerns about potential harm to the fetus. That leaves us with little data to help us make decisions about medications and vaccines.

Instead we’re on our own, winging it during an already vulnerable time. And as I care for a ballooning number of coronavirus-positive patients each day, my decision about the vaccine seems more urgent than ever.

The news of my pregnancy was a joyful moment for my family in a difficult year, but Covid-19 has been a terrifying backdrop. I practice in Camden, N.J., and our community has been hard-hit. Infections are soaring above the springtime peak. My inbox contains positive case after positive case.

My patients are the most essential of essential workers — home health aides, warehouse workers, janitors — still, even after all we’ve learned this year, with little job security, minimal paid sick leave and inadequate personal protective equipment. And as my patients get exposed to the virus, so do I.

The data on coronavirus infection during pregnancy are not reassuring. Pregnant people who get the virus seem to have a higher risk for severe symptoms and complications, and there also may be a small increased risk of preterm birth. Each day I walk into my clinic, I ask myself, “Will this be the day I get it?”

The early news about the efficacy of the vaccines was thrilling. But there has been little data on how the vaccine affects pregnant people. No pregnant patients were enrolled in the early trials, although some people got pregnant during the course of the study. Researchers are monitoring them to see how they do.

According to Ruth Faden, a Johns Hopkins bioethicist who studies vaccine policy, the reluctance to include pregnant research subjects in clinical trials has a long history.

“There’s an inertia that’s set in,” she told me. Studying pregnant people requires extra effort in safe study design and recruitment efforts, so rather than do the hard work, she says, pregnant women are often just excluded altogether.

“It’s an ethically complex situation,” she added. “Pregnancy is like nothing else. Anything you do to a pregnant woman also has a chance of affecting the developing offspring.”

Researchers estimate we have adequate data on the risk of birth defects in less than 10 percent of medications approved by the Food and Drug Administration since 1980. That means any time a pregnant person thinks about using a medication or vaccine, she might feel like she’s making a decision at random, without any rigorous information to guide her.

That’s certainly how I feel right now. My medical training taught me to respect my patients’ autonomy; I see my job as guiding them through confusing medical information and helping them make decisions, not making decisions for them. Patient autonomy is a primary value in medicine.

I was glad to see that the F.D.A. left the choice of whether or not to get the Covid-19 vaccine up to pregnant women, rather than excluding us from eligibility altogether. For a pregnant nursing home aide, or a pregnant intensive care unit nurse, the risk of getting Covid-19 might be greater than the risk of any potential vaccine side effects.

This isn’t a theoretical exercise for hundreds of thousands of health care workers. Women make up an estimated 76 percent of the health care work force, many of us of childbearing age. I have text message chains with several pregnant and breastfeeding physician friends, all of us trying to sort through the limited information we have.

But without any data to guide me, my autonomy to make the decision doesn’t feel as meaningful. The American College of Obstetricians and Gynecologists offered this wildly unsatisfying recommendation: “Covid-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination.” The Centers for Disease Control and Prevention issued similarly noncommittal guidance: “Health care personnel who are pregnant may choose to be vaccinated.” Both are a far cry from the two organizations’ enthusiastic support for the flu vaccine in pregnancy, for example.

So it’s up to me and my nurse midwife, both of us smart clinicians, but not vaccine experts. I asked her what she thought, and she told me, “Honestly, I have no idea.”

I try to weigh the costs and benefits: I care for positive patients, but it’s not as if I’m an I.C.U. doctor. Many vaccines are safe in pregnancy — I gladly got my flu shot early on — but other vaccines aren’t. How can I weigh the costs and benefits if I don’t know what the costs are?

The two vaccines that have now been approved use a novel messenger RNA technology that has not been studied in pregnancy. It’s possible the mRNA and the bubble it travels in, made of lipid nanoparticles, could cross the placenta, according to Dr. Michal Elovitz, a preterm labor researcher and obstetrician at the University of Pennsylvania. This might, in theory, cause inflammation in utero that could be harmful to the developing fetal brain.

Or, the lipid nanoparticles might not cross the placenta, Dr. Elovitz says. It’s also possible the new vaccines could be totally safe in pregnancy, like the flu shot. We just don’t have the data yet.

“To avoid having pregnant people guess, we should be advocating for more preclinical and clinical research focused on pregnant patients,” she told me.

My bottom line: If I have the chance, I’ll gladly enroll in a clinical trial of a Covid-19 vaccine for pregnant people. It’s a choice that feels much more grounded in science than trying to figure this out on my own, because I’d be making it alongside the expertise of the scientists designing the trial.

I’d feel reassured that experts in immunology and pregnancy physiology had determined the safest trimester to get the vaccine. I’d feel reassured that they had done that using evidence from animal studies, and I’d feel reassured by the ethics board that approved the trial. It wouldn’t be a risk-free decision, but it would make me feel like it wasn’t a totally reckless one.

Until then, I’ll take care of my patients with my mask, my face shield, and my gloves, hoping I don’t get infected, thinking every day about my health and the health of my baby.

Dr. Mara Gordon is a family physician in Camden, N.J.

What People With Allergies Should Know About Covid Vaccines

Here’s What People With Allergies Should Know About Covid Vaccines

Four people so far have had allergic reactions after getting the Pfizer-BioNTech vaccine. Experts say that shouldn’t deter most people from getting a jab.

Vaccinations underway in Orange, Calif., on Wednesday.
Vaccinations underway in Orange, Calif., on Wednesday.Credit…Jenna Schoenefeld for The New York Times
Katherine J. Wu

  • Dec. 18, 2020, 12:27 p.m. ET

Allergic reactions reported in two health workers who received a dose of Pfizer’s vaccine in Alaska this week have reignited concerns that people with a history of extreme immune flare-ups might not be good candidates for the newly cleared shots.

The two incidents follow another pair of cases in Britain. Three of the four were severe enough to qualify as anaphylaxis, a severe and potentially life-threatening reaction. But all four people appear to have recovered.

Health officials on both sides of the pond are vigilantly monitoring vaccinated people to see if more cases emerge. Last week, British drug regulators recommended against the use of Pfizer’s vaccine in people who have previously had anaphylactic reactions to food, medicines or vaccines.

And on Thursday, Dr. Doran Fink, deputy director of the Food and Drug Administration’s clinical division of vaccines and related products applications, addressed the issue during a meeting about the vaccine made by Moderna that contains similar ingredients and is expected to soon receive emergency use authorization, or E.U.A., from the agency.

“We anticipate that there may be additional reports, which we will rapidly investigate,” Dr. Fink said, adding that robust surveillance systems were in place to detect these rare events.

Still, Dr. Fink said that “the totality of data at this time continue to support vaccinations under the Pfizer E.U.A., without new restrictions.”

The F.D.A., he added, would work with Pfizer to revise fact sheets and prescribing information for the vaccine so that the public would understand the risk of allergic reactions and know how to report them.

What do we know about the people who had bad reactions?

The first two confirmed cases of allergic reactions came from two health care workers in Britain. Both had a medical history of serious allergic reactions, but had not previously been known to have trouble with any of the vaccine’s ingredients. After an injection of epinephrine — the typical treatment for anaphylaxis — both recovered.

(A third British incident described as a “possible allergic reaction” was also reported and appears to have been minor.)

On Wednesday, two health workers in Alaska experienced reactions as well. One was too mild to be deemed anaphylaxis. But the other, which occurred in a middle-aged woman with no history of allergies, was serious enough to warrant hospitalization, even after she got a shot of epinephrine.

“What is happening does seem really unusual to me,” said Dr. Kimberly Blumenthal, an allergist, immunologist and drug allergy researcher at Massachusetts General Hospital. Vaccine-related allergic reactions are typically rare, occurring at a rate of about one in a million.

Dr. Blumenthal also pointed out that it was a bit bizarre to see allergic reactions clustering in just two locations: Britain and Alaska. Zeroing in on the commonalities between the two hot spots, she said, might help researchers puzzle out the source of the problem.

Do we know for sure that their reactions were caused by the vaccine?

British and U.S. agencies are investigating the causes, but no official has declared a direct link.

But Dr. Blumenthal suspects they were connected to the shots, because the reactions were immediate, occurring within minutes of injection.

“We have to think it was related because of the timing,” she said.

Nor is it known if a particular ingredient might have been the cause. Pfizer’s vaccine contains just 10 ingredients. The most important is a molecule called messenger RNA, or mRNA — genetic material that can instruct human cells to make a coronavirus protein called spike. Once manufactured, spike teaches the immune system to recognize the coronavirus so it can be fought off in the future. Messenger RNA, which is naturally found in human cells, is unlikely to pose a threat, and degrades within about a day of being injected.

The other nine ingredients are a mix of salts, fatty substances and sugars that stabilize the vaccine. None are common allergens. The only chemical with a history of causing allergic reactions is polyethylene glycol, or PEG, which helps package the mRNA into an oily sheath, protecting it as it goes into human cells.

But PEG is, generally speaking, inert and widespread. It’s found in ultrasound gel, laxatives like Miralax and injectable steroids, among other drugs and products, Dr. Blumenthal said. Despite the chemical’s ubiquity, she said, “I’ve only seen one case of a PEG allergy — it’s really, really uncommon.”

It’s still possible that something else could be causing the reactions — perhaps a factor related to how the vaccines are transported, thawed or administered, Dr. Blumenthal said.

Did the volunteers in Pfizer’s clinical trials have any bad reactions?

A small number of volunteers in Pfizer’s clinical trials experienced allergic reactions. Just one of the 18,801 participants who received the vaccine in a late-stage trial had anaphylaxis, and the incident was deemed unrelated to the vaccine, said Steven Danehy, a spokesman for Pfizer. No severe reactions were found in people who got a placebo shot.

Pfizer excluded people with a history of anaphylaxis to vaccines from its clinical trials.

What does the F.D.A. say about these reactions?

Several experts raised concerns about the allergic reactions in meetings convened to discuss both Pfizer’s and Moderna’s vaccines. The agency has advised caution, noting that health care providers should not administer the vaccine to anyone with a “known history of a severe allergic reaction” to any component of the vaccine — a standard warning for vaccines.

Should people with mild allergies wait to get vaccinated?

There’s no evidence that people with mild allergies, which are quite common, need to avoid the vaccine. Allergies are, simply put, the product of an inappropriate immune response against something harmless — pollen, peanuts, cat dander and the like. In many cases, the results of this overreaction are mild symptoms such as a runny nose, coughing or sneezing.

But allergies are specific: A reaction to one substance does not guarantee a reaction to another. On Monday, the American College of Allergy, Asthma and Immunology released guidance stating that people with common allergies “are no more likely than the general public to have an allergic reaction to the Pfizer-BioNTech Covid-19 vaccine.”

William Amarquaye, a clinical pharmacist at Brandon Regional Hospital, said he wouldn’t let his asthma or allergies stop him from taking the vaccine when it is offered to him in the next few weeks. He’s also never had trouble with other vaccines he has taken in the past.

“It should still be OK to take the vaccine,” Dr. Amarquaye said. “I’m actually excited about it.”

What about people with a history of severe allergies?

Most people in this category should be good to go, too, said Dr. Eun-Hyung Lee, an expert in allergy and immunology at Emory University.

Guidelines released by the Centers for Disease Control and Prevention identify only one group of people who might not want to get Pfizer’s vaccine: those with a known history of severe allergic reactions to an ingredient in the injection.

People with a history of anaphylaxis to any other substance, including other vaccines or injectable drugs, can still get the vaccine, but should consult their health care providers and be monitored for 30 minutes after getting their shots. Everyone else, like people with mild or no allergies, need to wait only 15 minutes before leaving the vaccination site.

“In general, the immediate reactions that require epinephrine are those that happen within the first 30 minutes,” said Dr. Merin Kuruvilla, an allergist and immunologist at Emory University.

Some people will understandably be concerned. Dr. Taison Bell, a critical care physician at UVA Health in Charlottesville, Va., said he worried about his 7-year-old son, Alain, who is severely allergic to several foods, including wheat, peanuts and cow’s milk. Alain has about two bouts of anaphylaxis each year.

It’s a bit of a relief that Alain is “later in the prioritization schema,” Dr. Bell said. By the time a vaccine is ready for him, he said, “we’ll get a better sense for how serious this is.” The family plans to discuss their situation with Alain’s doctor.

Ultimately, it’s unlikely that any of the ingredients in a coronavirus vaccine would cause Alain any issues. Alain has tolerated other vaccines, including the flu shot, in previous years, and is looking forward to his own shot at immunization to the coronavirus, said Dr. Bell, who received his first dose of Pfizer’s vaccine on Tuesday.

What about Moderna’s vaccine?

Two volunteers in Moderna’s late-stage clinical trial developed anaphylactic reactions, the company reported at the F.D.A. committee meeting on Thursday. Neither was deemed to be linked to the company’s vaccine, which also contains mRNA, because they occurred weeks or months after the participants received their shots. One of these volunteers also had a history of asthma and a shellfish allergy.

Moderna, unlike Pfizer, did not exclude people with a history of anaphylaxis from its trials.

Dr. Tal Zaks, the company’s chief medical officer, said that while Moderna’s vaccine recipe was similar to Pfizer’s, key molecular differences existed that could set the two products on different paths. He said that bad reactions to Pfizer’s vaccine did not guarantee that similar events would happen in relation to the Moderna shots.

Both vaccines do, however, include a version of PEG.

Dr. Blumenthal and others said that anyone concerned about having an allergic reaction to a vaccine should seek the advice of a health care provider.

For anyone getting the vaccine, it’s all about “balancing out the risks,” Dr. Lee, of Emory, said. Allergic reactions can be dangerous. But they are rare and treatable, and the tools to combat them should be available at all vaccination sites. The coronavirus, on the other hand, can have far graver consequences.

“When it’s my turn in line, I think weighing these odds is what I would do,” Dr. Lee said.

New Scan Finds Prostate Cancer Cells Hiding in the Body

New Scan Finds Prostate Cancer Cells Hiding in the Body

The test seems likely to improve the diagnosis and treatment of a disease that kills 33,000 American men each year.

Dr. Mark Samberg, a retired urologist in Sacramento, learned his cancer had spread beyond his prostate with a new scan that finds radioactively tagged cancer cells in the body. 
Dr. Mark Samberg, a retired urologist in Sacramento, learned his cancer had spread beyond his prostate with a new scan that finds radioactively tagged cancer cells in the body. Credit…Max Whittaker for The New York Times
Gina Kolata

  • Dec. 16, 2020, 2:08 p.m. ET

After doctors found cancer in Dr. Mark Samberg’s prostate last spring, the 70-year-old retired urologist prepared to have his prostate removed. He knew that the surgery would cure him, assuming the cancer was confined to the organ.

But his doctors had a nagging concern — the cancer cells seen on the biopsy were aggressive and may already have escaped from his prostate. If so, the operation would not cure him. The problem for Dr. Samberg, and for many men with aggressive prostate cancer, was this: If there are cancer cells outside the prostate, how can they be found?

Now the Food and Drug Administration has approved a test that can locate prostate cancer cells wherever they are. Exuberant cancer specialists said the test would alter treatment for patients nationwide.

“It’s the most exciting thing in prostate cancer in my lifetime,” said Dr. Kirsten Greene, chair of the urology department at the University of Virginia School of Medicine.

The test relies on a radioactive tag attached to a molecule that homes in on prostate cancer cells that have spread to other locations in the body and may seed new tumors. Once tagged, the clusters of cells appear as bright spots on PET scans.

At the moment, the F.D.A.’s approval applies only to testing at the University of California, San Francisco, and the University of California, Los Angeles, which conducted clinical trials. But several companies hope to market similar tests soon.

“It’s absolutely fabulous,” said Dr. Oliver Sartor, professor of medicine at Tulane University School of Medicine. When he learned that the test had been approved, he said, he danced in his office “and had a toast of imaginary champagne.”

Now specialists are hoping to use the technique to kill cancer cells, not just find them. The idea is to attach a radioactive drug to the molecule that seeks out prostate cancer cells. The molecule will deliver the drug directly to those cells and, it is hoped, the radiation will destroy the cancer. Experiments already have begun at U.C.S.F. and U.C.L.A.

The road to the new test has been long. Nearly 30 years ago, researchers discovered that prostate cancer cells carry a unique protein on their surfaces called prostate specific membrane antigen, or P.S.M.A. More recently, researchers found small molecules that could home in on P.S.M.A.

Scientists theorized that radioactive tracers attached to those molecules could make prostate cancer cells visible on PET scans. In 2010, researchers at the University of Heidelberg in Germany published the first images of prostate cancer cells located in this way.

Over the past four years, studies involving about 1,000 patients by Dr. Jeremie Calais, a nuclear medicine physician at U.C.L.A., and Dr. Thomas Hope, a nuclear medicine physician at U.C.S.F., showed that the scan accurately detected prostate cancer cells anywhere in the body before treatment and even after treatment, when cancer may recur.

The research led to changes in treatment for most patients, including decisions to recommend targeted radiation, guided by the scans, rather than chemotherapy or androgen-blocking therapy, treatments that impact the entire body.

Dr. Hope described two situations in which the PET scans can transform treatment decisions.

Most men learn they have prostate cancer when a simple blood test finds high levels of prostate specific antigen, or P.S.A. The next step is a biopsy of the prostate and removal of cancer cells for examination to see how aggressive they appear.

Men often have MRI scans to see if the capsule surrounding the prostate has been breached — a sign the cancer has gotten out. And doctors consider how high P.S.A. levels are. The higher they are, the more cancer in the body and the more likely it has spread.

The second scenario occurs after a man has had his prostate removed or destroyed by radiation. If the patient’s P.S.A. levels start to rise months or years later, the cancer that doctors thought they had cured had already seeded itself elsewhere in the man’s body.

In both situations, “we know they have disease, but we don’t know where it is,” Dr. Hope said. The new scan seems able to show doctors where to look. The researchers are now conducting studies to see if these treatment revisions ultimately prolong patients’ lives.

Dr. Samberg, who lives in Sacramento, was one of the participants in the U.C.S.F. trial. Before his scheduled prostatectomy, the scan turned up cancerous cells in his bones and lymph nodes. “That was shocking,” he said.

Without the new test, the doctors would have removed Dr. Samberg’s prostate, and they would have realized he still had cancer when his P.S.A. levels began to rise. In such a case, doctors usually irradiate the area where the prostate used to be — the prostate bed, which is the site of remaining cancers a bit more than half the time.

For Dr. Samberg, that procedure, like the prostatectomy, would not have helped. “Standard therapy for me would fail,” he said. Instead, the discovery that his cancer was in his bones and lymph nodes pointed to targeted radiation therapy, hormonal therapy and, most recently, immunotherapy.

“I am in complete remission,” Dr. Samberg said. “I hope it makes a difference long term.”

Answers to Your Questions About the New Covid Vaccines in the U.S.

Answers to Your Questions About the New Covid Vaccines in the U.S.

Vaccines are rolling out to health workers now and will reach the arms of the rest of us by spring. Here’s what you need to know.

The Pfizer-BioNTech Covid vaccines are prepared to be shipped at a Pfizer plant on Dec. 13, 2020 in Portage, Michigan.
The Pfizer-BioNTech Covid vaccines are prepared to be shipped at a Pfizer plant on Dec. 13, 2020 in Portage, Michigan.Credit…Pool photo by Morry Gash
  • Dec. 14, 2020, 1:47 p.m. ET

Getting the vaccine

Why can’t everyone get the vaccine now?

There aren’t enough doses for everyone, so initially the vaccine will be rationed for those who need it most. It will take time to produce and distribute the vaccine, and then schedule two vaccinations per person, three to four weeks apart. As more vaccines get approved, things will speed up. At least 40 million doses (enough for 20 million people) should be available from Pfizer and Moderna by the end of the year, and much more will come in 2021. How many doses will your state get? Look up your state’s vaccine distribution plans here. —Abby Goodnough

Who will get the vaccine first?

Here’s the expected order for vaccinations:

  • Health care workers and people in long-term care facilities: The nation’s 21 million health care workers and three million mostly elderly people living in long-term care facilities will go first, starting in December. Initially, there won’t be enough doses to vaccinate all health care workers, so states will prioritize based on exposure risk, choosing emergency room staff, for instance, to go first. Or they may offer the vaccine to the oldest health care workers first.

  • Essential workers: The 87 million Americans who work in food and agriculture, manufacturing, law enforcement, education, transportation, corrections, emergency response and other sectors, likely will be second in line, starting early next year. States will set priorities. Arkansas, for example, has proposed including workers in its large poultry industry, while Colorado wants to include ski industry workers who live in congregate housing.

  • Adults with underlying medical conditions and people over 65. Health officials are hoping to get any remaining older adults who have not been vaccinated sometime in the first quarter. Some states might decide to vaccinate residents over 75 before some types of essential workers.

  • All other adults. Adults in the general population are at the back of the line. They could start receiving the vaccine as early as April, said Dr. Anthony S. Fauci, the nation’s top infectious disease expert, although many people likely will have to wait until at least May or June. The vaccine hasn’t been approved in children, so it may be several months, or possibly a year, before the vaccine is available for anyone under the age of 16. —Abby Goodnough, Tara Parker-Pope

How will the first doses of the vaccine get to health workers?

Hospitals and medical groups are contacting health workers to schedule vaccine appointments. FedEx and UPS will transport the vaccine throughout most of the country, and each delivery will be followed by shipments of extra dry ice a day later.

Pfizer designed special containers, with trackers and enough dry ice to keep the doses sufficiently cold for up to 10 days. Every truck carrying the containers will have a device that tracks its location, temperature, light exposure and motion. Pfizer will ship the special coolers, each containing at least 1,000 doses, directly to locations determined by each state’s governor. At first, almost all of those sites will probably be hospitals that have confirmed they can store shipments at minus 94 degrees Fahrenheit, as the Pfizer vaccine requires, or use them quickly. —Abby Goodnough

How will the vaccine get to nursing homes?

The pharmacy chains CVS and Walgreens have contracts with the federal government to send teams of pharmacists and support staff into thousands of long-term care facilities in the coming weeks to vaccinate all willing residents and staff members. CVS and Walgreens are both planning to administer their first vaccinations on Dec. 21.

More than 40,000 facilities have chosen to work with CVS. Nearly 35,000 picked Walgreens. Each U.S. state has already picked, or will soon pick, either the Pfizer or the Moderna vaccine for all of its long-term care facilities that will be working with the pharmacies. —Rebecca Robbins, Abby Goodnough

How will the rest of us get vaccinated?

It’s likely that when the general public starts getting vaccinated in April, shots will be scheduled through doctor’s offices, CVS, Walgreens and other pharmacies — the same way people get flu shots. However, final plans will depend on what other vaccines besides Pfizer’s and Moderna’s have been approved. —Abby Goodnough, Rebecca Robbins

Can I choose which vaccine I get?

This depends on a number of factors, including the supply in your area at the time you’re vaccinated and whether certain vaccines are found to be more effective in certain populations, such as older adults. At first, the only choice will be Pfizer’s vaccine, though Moderna’s could become available within weeks. —Abby Goodnough

How long will it take to work?

You won’t get the full protection from the Pfizer-BioNTech vaccine until about a week after the second dose, based on clinical trial data. The researchers found that the vaccine’s protection started to emerge about ten days after the first dose, but it only reached 52 percent efficacy, according to a report in the New England Journal of Medicine. A week after the second dose, the efficacy rose to 95 percent. Read more here. —Carl Zimmer, Noah Weiland

Safety and side effects

Will it hurt? What are the side effects?

The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain.

While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity. —Abby Goodnough, Carl Zimmer

How do I know it’s safe?

Each company’s application to the F.D.A. includes two months of follow-up safety data from Phase 3 of clinical trials conducted by universities and other independent bodies. In that phase, tens of thousands of volunteers got a vaccine and waited to see if they became infected, compared with others who received a placebo. By September, Pfizer’s trial had 44,000 participants; no serious safety concerns have been reported. — Abby Goodnough

If I have allergies, should I be concerned?

People with severe allergies who have experienced anaphylaxis in the past should talk to their doctors about how to safely get the vaccine and what precautions to take. Although severe reactions to vaccines are rare, two health care workers had anaphylaxis after receiving the vaccine on the first day it became available in Britain. Both workers, who had a history of severe reactions, were treated and have recovered. (Anaphylaxis can be life-threatening, with impaired breathing and drops in blood pressure that usually occur within minutes or even seconds after exposure to a food, medicine or substance like latex.) For now, British authorities have said the vaccine should not be given to anyone who has ever had an anaphylactic reaction, but U.S. health experts have said such warnings are premature because severe reactions can be treated or prevented with medications. Because of the British cases, the F.D.A. said it would require Pfizer to increase its monitoring for anaphylaxis and submit data on it once the vaccine comes into use. Fewer than one in a million recipients of other vaccines a year in the U.S. have an anaphylactic reaction, said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

Among those who participated in the Pfizer trials, a very small number of people had allergic reactions. A document published by the F.D.A. said that 0.63 percent of participants who received the vaccine reported potential allergic reactions, compared to 0.51 percent of people who received a placebo. In Pfizer’s late-stage clinical trial, one of the 18,801 participants who received the vaccine had an anaphylactic reaction, according to safety data published by the F.D.A. on Tuesday. None in the placebo group did. Read more here. — Denise Grady

What about my situation? Answers about different types of patients.

I had Covid-19 already. Do I need the vaccine?

It’s safe, and probably even beneficial, for anyone who has had Covid to get the vaccine at some point, experts said. Although people who have contracted the virus do have immunity, it is too soon to know how long it lasts. So for now, it makes sense for them to get the shot. The question is when. Some members of the C.D.C. advisory committee have suggested people who have had Covid in the past 90 days should be toward the back of the line.Read more here. —Abby Goodnough, Apoorva Mandavilli

Will it work on older people?

All the evidence we have so far suggests that the answer is yes. The clinical trials for the two leading vaccines have shown that they work about the same in older people as younger people. As the vaccines get distributed, the vaccine makers and the C.D.C. will continue to monitor the effectiveness of the vaccine in people 65 and older who, because of age-related changes in their immune systems, often don’t respond as well to vaccination as younger people do. But just as certain flu vaccines have been developed to evoke a stronger immune response in older people, it’s possible that one of the new vaccines could emerge as a better option for this age group. It’s just far too soon to know. —Carl Zimmer

I’m young and at low risk. Why not take my chances with Covid-19 rather than get a vaccine?

Covid-19 is by far the more dangerous option. Although people who are older, obese or have other health problems are at highest risk for complications from Covid-19, younger people can become severely ill, too. In a study of more than 3,000 people ages 18 to 34 who were hospitalized for Covid, 20 percent required intensive care and 3 percent died.

And as many as one in three people who recover from Covid have chronic complaints, including exhaustion, a racing heart and worse for months afterward. Covid vaccines, in contrast, carry little known risk. Read more here. —Apoorva Mandavilli

Vaccinating pregnant women and children

What about women who are pregnant or breastfeeding?

Pregnant and breastfeeding women should consult with their obstetricians and pediatricians about whether to get the vaccine. The Pfizer vaccine has not been tested in pregnant women or in those who were breastfeeding, and federal health officials have not issued any specific guidance, other than allowing these women to be vaccinated if they choose. (The American College of Obstetricians and Gynecologists issued practice guidelines to help women and their doctors talk about vaccination.)

In the initial rollout, it will be mostly pregnant health care workers who must weigh the benefits and possible risks. By the time the vaccine is available to pregnant essential workers or to women in the general population, there should be a lot more data available.

Some experts said the virus itself poses greater risks to pregnant women than the new vaccine. Since the 1960s, pregnant women have been urged to receive vaccines against influenza and other diseases. These women are generally cautioned against live vaccines, which contain weakened pathogens — but the Pfizer vaccine does not contain live virus. Read more here.Apoorva Mandavilli

Does the vaccine affect fertility or miscarriage risk?

A false claim has been circulating online that the new vaccine will threaten women’s fertility by harming the placenta. Here’s why it’s not true.

The claim stems from the fact that the vaccines from Pfizer and Moderna cause our immune systems to make antibodies to something called a “spike” protein on the coronavirus. The false warnings about fertility are based on the claim that these antibodies could also attack a similar protein that is made in the placenta during pregnancy, called syncytin. In reality, the spike protein and syncytin are similar only in one very small region, and there’s no reason to believe antibodies that can grab onto spike proteins would lock onto syncytin.

What’s more, the human body generates its own supply of spike antibodies when it fights off the coronavirus, and there’s no sign that these antibodies attack the placenta. If they did, you’d expect that women who got Covid-19 would suffer miscarriages. But a number of studies show that Covid-19 does not trigger miscarriages. Read more here. —Carl Zimmer

When will vaccines be available for children?

So far, no coronavirus vaccine has been approved for children. New vaccines are typically tested on adults before researchers launch trials on children, and coronavirus vaccine developers are following this protocol. In September, Pfizer and BioNTech began studying their vaccine on children as young as 12. Moderna followed suit in December. If these trials yield good results, the companies will recruit younger children. The FDA will then have to review these results before the vaccines can get emergency authorization. Read more here.—Carl Zimmer

Why weren’t children included in the early studies?

Vaccines are typically tested on adults first in the interest of safety. But once a vaccine is shown to be safe and effective in adults, researchers have to run more trials on children to adjust the dosage for their bodies. Another factor in the wait for a vaccine for children is that they are far less likely to die from Covid-19 than adults are. The Centers for Disease Control and Prevention issued a report in September which concluded that, of more than 190,000 people who died in the United States with Covid-19, only 121 were under the age of 21. —Carl Zimmer and Katie Thomas

Life after vaccination

What if I forget to take the second dose on time?

Both the vaccines from Pfizer-BioNTech and from Moderna have two doses, with the booster shot coming a few weeks after the first. Pfizer-BioNTech’s second dose comes three weeks after the first, and Moderna’s comes four weeks later. The second dose provides a potent boost that gives people strong, long-lasting immunity.

If for some reason you fail to get the second shot precisely three weeks after the first, you don’t have to start all over again with another two-dose regimen. “The second dose can be picked up at any time after the first. No need to start the series over,” said Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s vaccine advisory panel.

And while the two leading vaccines include a second dose, some future vaccine candidates may only require one dose. Johnson & Johnson, for example, is expecting data in January that will show whether its experimental vaccine works after a single dose. In case it doesn’t, the company has also started a separate trial using two doses. —Carl Zimmer, Tara Parker-Pope

If I’ve been vaccinated, will I still need to wear a mask?

Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick.

The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here. —Apoorva Mandavilli

Will my employer require vaccinations?

Employers do have the right to compel their workers to be vaccinated once a vaccine is formally approved. Many hospital systems, for example, require annual flu shots. But employees can seek exemptions based on medical reasons or religious beliefs. In such cases, employers are supposed to provide a “reasonable accommodation” — with a coronavirus vaccine, for example, a worker might be allowed to work if they wear a mask, or to work from home. —Abby Goodnough

How will we know when things are getting better?

The test positivity rate in your community will be an indicator of how things are going. This number is the percentage of overall tests given in a community that come back positive. The lower the number, the fewer new cases and the less likely you are to cross paths with someone who has the virus. “The best number is zero,” Dr. Fauci said. “It’s never going to be zero, but anywhere close to that is great.” —Tara Parker-Pope

When can we start safely doing normal things, like going to the movies or the theater?

Public health officials estimate that 70 to 75 percent of the population needs to be vaccinated before people can start moving freely in society again. If things go well, life could get a lot better by late spring and early summer. “It depends on the uptake of the vaccine and the level of infection in the community,” Dr. Fauci said.

Given the surveys so far showing significant public reluctance to get vaccinated, however, it may take awhile to see widespread community protection, he said: “If it turns out that only 50 percent get vaccinated, then it’s going to take much, much longer to get back to the kind of normality that we’d like to see.” —Tara Parker-Pope

Will these vaccines put a dent in the epidemic?

The coronavirus vaccines will be much less effective at preventing death and illness in 2021 if they are introduced into a population where the virus is raging — as is now the case in the U.S. A vaccine that’s 95 percent effective, as Moderna’s and Pfizer’s versions appear to be, is a powerful fire hose. But the size of a fire is still a bigger determinant of how much destruction occurs.

According to the authors of a paper in the journal Health Affairs, at the current level of infection in the U.S. (about 200,000 confirmed new infections per day), a vaccine that is 95 percent effective — distributed at the expected pace — would still not be enough to end the terrible toll of the virus in the six months after it was introduced. Almost 10 million or so Americans would still contract the virus, and more than 160,000 would die.

Measures that reduce the virus’s spread — like mask-wearing, social distancing and rapid-result testing — can still have profound effects. Public health officials hope that people will continue to take these precautions at least until the country reaches a vaccination rate of 70 to 75 percent. —David Leonhardt

Will I be required to provide proof of vaccination to travel?

In the coming weeks, major airlines including United, JetBlue and Lufthansa plan to introduce a health passport app, called CommonPass, that aims to verify passengers’ coronavirus test results — and perhaps soon, vaccinations. CommonPass notifies users of local travel rules — like having to provide proof of a negative virus test — and then aims to check that they have met them.

Although no plans are in place yet to require proof of vaccination for travel or other activities, electronic vaccination credentials could have a profound effect on efforts to control the virus and restore the economy. They could prompt more employers and college campuses to reopen. And developers say they may also give some consumers peace of mind by creating an easy way for movie theaters, cruise ships and sports arenas to admit only those with documented virus vaccinations. Read the full story. —Natasha Singer

How long will the vaccine last? Will I need another one next year?

That is to be determined. It’s possible that coronavirus vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. Immunity from coronavirus infections appears to last for months, at least, so that may be a hint about vaccines. —Carl Zimmer

How the different vaccines work

How do these new genetic vaccines work?

The Pfizer-BioNTech and Moderna vaccines use a genetic molecule to prime the immune system. That molecule, known as mRNA, is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. While the immune protection from these vaccines may last for months or perhaps even years, their mRNA does not — it is destroyed by our cells within days. Although these are described as “genetic” vaccines, the vaccines don’t alter your genes in any way. —Carl Zimmer

What do the vaccine developers mean when they say their vaccines are 95 percent effective?

Vaccine developers test their vaccines in clinical trials. The fundamental logic behind these trials was worked out by statisticians over a century ago. Researchers vaccinate some people and give a placebo to others. They then wait for participants to get sick and look at how many of the illnesses came from each group.

In the case of Pfizer, for example, the company recruited 43,661 volunteers and waited for 170 people to come down with symptoms of Covid-19 and then get a positive test. Among those who got sick, 162 had received a placebo shot, and just eight had received the real vaccine. This result shows that receiving a vaccine dramatically lowered the chances of getting Covid-19 compared to receiving a placebo.

The difference is expressed as efficacy: the Pfizer-BioNTech vaccine has an efficacy rate of 95 percent. (If there were no difference between the vaccine and placebo groups, the efficacy would be zero. If none of the sick people had been vaccinated, the efficacy rate would have been 100 percent.) A vaccine’s efficacy rate and effectiveness rate are different: Efficacy is a measurement made within the strict confines of a clinical trial, whereas effectiveness refers to how a vaccine works in the real world. No one knows yet the true effectiveness of these new vaccines. —Carl Zimmer

Was the Pfizer vaccine part of the government’s Operation Warp Speed?

Pfizer did not accept federal funding to help develop or manufacture the vaccine, unlike front-runners Moderna and AstraZeneca. Pfizer did get a $1.95 billion deal with the government to deliver 100 million doses of the vaccine. The arrangement is an advance-purchase agreement, meaning that the company won’t get paid until they deliver the vaccines. Read more here. —Carl Zimmer and Katie Thomas

What does the rollout of the Pfizer vaccine mean for the other vaccines in the race?

Researchers were heartened by the strong results of the vaccine developed by Pfizer and BioNTech. “It gives us more hope that other vaccines are going to be effective too,” said Akiko Iwasaki of Yale University.

The Moderna vaccine, which is next in line for approval, has an efficacy rate of 94.5 percent, essentially the same as the Pfizer-BioNTech vaccine. A vaccine from AstraZeneca and the University of Oxford has shown confusing trial results, with efficacy rates between 60 and 90 percent, depending on the strength of the doses that volunteers received. And the French company Sanofi had a major disappointment in its early clinical trials, finding that its vaccine couldn’t provoke an immune response in people over 55. The company is now reformulating its vaccine to start new trials. —Carl Zimmer and Katie Thomas

Reporting contributed by:

Abby Goodnough, Carl Zimmer, Rebecca Robbins, Apoorva Mandavilli, Denise Grady Katie Thomas, Tara Parker-Pope, Noah Weiland, Natasha Singer, David Leonhardt, Roni Caryn Rabin, Julie Bosman, Reed Abelson and Richard Pérez-Peña

Pregnant and Breastfeeding Women May Opt to Receive the Vaccine

Pregnant and Breastfeeding Women May Opt to Receive the Vaccine

Although no coronavirus vaccine has been studied in these women, many scientists believe the benefits will outweigh any potential risks.

With vaccines in short supply, the F.D.A.’s decision most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States.
With vaccines in short supply, the F.D.A.’s decision most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States.Credit…Callaghan O’Hare/Reuters
Apoorva Mandavilli

  • Dec. 11, 2020, 11:14 p.m. ET

In its emergency authorization of the Pfizer-BioNTech vaccine on Friday night, the Food and Drug Administration took an unexpected step, leaving open the possibility that pregnant and breastfeeding women may opt for immunization against the coronavirus.

The agency authorized the vaccine for anyone 16 and older, and asked Pfizer to file regular reports on the safety of the vaccine, including its use in pregnant women.

There had been no guarantee that the agency would take this route. The vaccine was not tested in pregnant women or in those who were breastfeeding. Regulators in the United Kingdom recommended against these women receiving the shots even while acknowledging that the evidence so far “raises no concerns for safety in pregnancy.”

The Centers for Disease Control and Prevention has not yet endorsed the vaccine for pregnant women, but an advisory committee to the agency is expected to meet this weekend to make further recommendations.

Some experts said the virus itself poses greater risks to pregnant women than the new vaccine, and noted that vaccines have been given to pregnant women for decades and have been overwhelmingly safe.

“This is a really huge step forward in recognizing women’s autonomy to make decisions about their own health care,” said Dr. Emily Miller, an obstetrician at Northwestern University and a member of the Covid-19 task force of the Society for Maternal and Fetal Medicine.

With the first doses of the vaccine reserved for health care workers and residents of long-term care facilities, the F.D.A.’s authorization most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States.

“I am incredibly supportive of the F.D.A.’s decision to leave the door open to Covid vaccination for pregnant and lactating workers,” said Ruth Faden, a bioethicist at Johns Hopkins University in Baltimore.

Some health care workers are at high risk of Covid-19, either because their jobs bring them into intense contact with the virus — for example, cleaning the rooms of sick patients — or because they live in low-income and multigenerational homes, Dr. Faden said.

“We have to be able to give women the opportunity to think through this for themselves with whoever it is providing obstetrical care to them,” she said.

Health care organizations should also help their employees weigh the risks, and accommodate women who do not feel comfortable working on the front lines, she added.

None of the vaccine clinical trials have so far included pregnant or lactating women, nor even women who are planning to get pregnant; some trials are expected to begin in January.

Still, the American College of Obstetrics and Gynecology, the S.M.F.M. and other organizations have been calling on the F.D.A. to allow pregnant and lactating people access to the vaccine.

At a meeting on Thursday to review Pfizer’s data for an emergency use authorization, Dr. Doran Fink, the F.D.A.’s deputy director for vaccine development, signaled that the agency was open to the idea.

“We really have no data to speak to risks specific to the pregnant women or the fetus, but also no data that would warrant a contraindication to use in pregnancy at this time,” Dr. Fink said. “Under the E.U.A., they would be then free to make their own decision in conjunction with their health care provider.”

The E.U.A. did not endorse the vaccine for pregnant or breastfeeding women, other than to note that Pfizer should collect long-term data on how the vaccine performs in pregnant women.

Since the 1960s, pregnant women have been urged to receive vaccines against influenza and other diseases. These women are generally cautioned against live vaccines, which contain weakened pathogens.

Even so, the benefits of live vaccines outweigh the risks in some situations, said Dr. Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of A.C.O.G.’s committee on Covid vaccines.

“We have a long track record of giving pregnant women vaccinations, and nearly all vaccinations are very safe,” Dr. Jamieson said.

Dr. Jamieson said she was “disappointed that F.D.A. was not more explicit” but encouraged that “there is no explicit contraindication regarding pregnancy, which is good.”

Health care providers should be prepared to counsel pregnant patients on the decision to be immunized, based on the patients’ potential exposures and underlying conditions like diabetes and obesity, Dr. Jamieson added.

“A woman who can stay home, who doesn’t have any other children and no one in the household is working, is very different than an essential worker who needs to go out every day and be around other people,” she said.

Women who are contemplating pregnancy should get both vaccine doses before trying to get pregnant, she added.

In the initial rollout, it will be mostly pregnant health care workers who must weigh the benefits and possible risks. By the time the vaccine is available to pregnant essential workers or to women in the general population, there should be a lot more data available, the experts said.

“The big question we don’t know quite yet is if it actually crosses the placenta,” said Dr. Geeta Swamy, an obstetrician at Duke University in Durham, N.C., and a member of A.C.O.G.’s Covid vaccine group, referring to the vaccine. “To be honest, what would be the most reassuring would be to see some of the animal data.”

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So-called D.A.R.T. — developmental and reproductive toxicity — studies are conducted in animals to assess a vaccine’s possible effects on a fetus. These data are typically required for licensing a vaccine, but not for an E.U.A.

Animal studies would ideally have been conducted as soon as safety data on the vaccines were available and before companies started large trials, Dr. Faden, the bioethicist, said. But at the F.D.A. meeting on Thursday, officials at Pfizer hinted that the animal data would be available by the end of the year.

(Moderna did not respond to queries about its timeline for animal studies, and it was unclear whether AstraZeneca and Johnson & Johnson had begun theirs.)

“The vaccines that are behind — if they haven’t started their D.A.R.T. studies, they should start them yesterday,” Dr. Faden said.

The experts were particularly enthusiastic about the prospect that breastfeeding women might get the vaccine. “The biologic plausibility to there being some risk of harm to an infant from breastfeeding is extremely, extremely low,” Dr. Swamy said.

In the time it would take an antigen — the essential ingredient in the new vaccine — injected into a woman’s arm to travel through her bloodstream and into breast milk, the antigen would disintegrate.

“There’s not a good reason even to think that vaccinating children is unsafe,” Dr. Swamy added. “To be honest, the reason we don’t have pediatric studies yet is because they’re trying to figure out the right dosage.”

Some women breastfeed for years and, particularly in low- and middle-income countries, not being able to do so may have devastating consequences for babies, experts said.

“I would applaud the fact that the F.D.A. has recognized that in the absence of data and meaning in either direction, decisions should be made between patients and their providers,” Dr. Swamy said. “We’re talking about women who are adult individuals, right?”

Moderna to Begin Testing Its Coronavirus Vaccine in Children

Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children

The company said the trial would involve children ages 12 through 17.

The study will include 3,000 children, with half receiving two shots of the vaccine four weeks apart.
The study will include 3,000 children, with half receiving two shots of the vaccine four weeks apart.Credit…Cody O’Loughlin for The New York Times

By

  • Dec. 2, 2020, 2:13 p.m. ET

The drugmaker Moderna said on Wednesday that it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed Wednesday on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water.

But the posting says the study is “not yet recruiting,” and Colleen Hussey, a spokeswoman for Moderna, said it was not certain when the testing sites would be listed or start accepting volunteers. A link on the website to test centers is not yet working, and Ms. Hussey said she was not sure when it would become active.

Moderna announced on Monday that data from its study in 30,000 adults had found its vaccine to be 94.1 percent effective, and that it had applied to the Food and Drug Administration for emergency authorization to begin vaccinating adults. If approval is granted, certain groups of high-risk adults, including people in nursing homes, could receive shots late in December.

But no vaccine can be widely given to children until it has been tested in them. Vaccines meant for both adults and children are generally tested first in adults to help make sure they are safe for pediatric trials.

Moderna’s vaccine has not yet been studied in children or pregnant women. In the new clinical trial in adolescents, girls past puberty will be tested before each injection to make sure they are not pregnant.

“Everyone anticipates that when we test this first in adolescents, then older children, then the real small kids, that the Covid vaccine will work,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and an adviser on vaccines to the Centers for Disease Control and Prevention.

But children have more active immune systems than adults, and may have stronger reactions, including more fever, muscle and joint aches, and fatigue, Dr. Schaffner said.

“They may be more out of sorts than adults for a day or two,” he said. “You really do want to know, if it’s given in adolescents, what can parents expect? You really want to be able to tell them clearly how you might feel for 24 or 48 hours after you receive the vaccine. And obviously, we really want to be able to tell parents it works.”

If a child had intense side effects and parents were not prepared for it, they might be reluctant to go back for the second shot, Dr. Schaffner said.

Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, said that vaccines “for the most part” work equally well in children and adults. Occasionally, as with the hepatitis B vaccine, different doses are required, he said. Moderna will study the same dose in children that it has tested in adults.

Pfizer began testing its coronavirus vaccine in children as young as 12 in October. A large clinical trial found its vaccine to be 95 percent effective in adults, and the company has requested emergency authorization from the F.D.A. Britain approved the Pfizer vaccine for adults on Wednesday, the first country to do so.

AstraZeneca has also tested its vaccine in children, but not in the United States.

As vaccine studies have moved forward, rumors have spread on social media, particularly among people who oppose vaccines in general, that President-elect Joseph R. Biden Jr. plans to require vaccination for everyone, including children. His team has denied those claims, and Mr. Biden has said that he will rely on scientists’ advice for the best way to end the pandemic.

Pursuing the Dream of Healthy Aging

Photo

Credit Paul Rogers

Given their druthers, most people would opt for a long and healthy life. Few relish the idea of spending years, even decades, incapacitated by illness, dependent on caregivers and unable to enjoy the people, places and activities that make life worth living.

In 1980, Dr. James F. Fries, a Stanford University physician who studied chronic disease and aging, proposed that a “compression of morbidity” would enable most people to remain healthy until a certain age, perhaps 85, then die naturally or after only a brief illness.

Now, a prescient group of experts on aging envisions a route to realizing Dr. Fries’s proposal: one or more drugs that can slow the rate of aging and the development of the costly, debilitating chronic ailments that typically accompany it. If successful, not only would their approach make healthy longevity a reality for many more people, but it could also save money. They say that even a 20 percent cut in how fast people age could save more than $7 trillion over the next half-century in the United States alone.

“Aging is by far the best predictor of whether people will develop a chronic disease like atherosclerotic heart disease, stroke, cancer, dementia or osteoarthritis,” Dr. James L. Kirkland, director of the Kogod Center on Aging at the Mayo Clinic, said in an interview. “Aging way outstrips all other risk factors.”

He and fellow researchers, who call themselves “geroscientists,” are hardly hucksters hawking magic elixirs to extend life. Rather, they are university scientists joined together by the American Federation for Aging Research to promote a new approach to healthier aging, which may — or may not — be accompanied by a longer life. They plan to test one or more substances that have already been studied in animals, and which show initial promise in people, in hopes of finding one that will keep more of us healthier longer.

As Dr. Kirkland wrote in a new book, “Aging: The Longevity Dividend”: “By targeting fundamental aging processes, it may be possible to delay, prevent, alleviate or treat the major age-related chronic disorders as a group instead of one at a time.”

His colleague S. Jay Olshansky, a gerontology specialist in the School of Public Health at the University of Illinois in Chicago, said it is often counterproductive to treat one disease at a time. Preventing cardiac death, for example, can leave a person vulnerable to cancer or dementia, he explained.

A better approach, Dr. Kirkland said, would be to target the processes fundamental to aging that underlie all age-related chronic diseases: chronic low-grade inflammation unrelated to infection; cellular degradation; damage to major molecules like DNA, proteins and sugars; and failure of stem cells and other progenitor cells to function properly.

The team, which includes Dr. Nir Barzilai, director of the Institute for Aging Research at Albert Einstein College of Medicine in The Bronx, and Steven N. Austad, who heads the biology department at the University of Alabama at Birmingham, plans to study one promising compound, a generic drug called metformin already widely used in people with Type 2 diabetes. They will test the drug in a placebo-controlled trial involving 3,000 elderly people to see if it will delay the development or progression of a variety of age-related ailments, including heart disease, cancer and dementia. Their job now is to raise the $50 million or so needed to conduct the study for the five years they expect it will take to determine whether the concept has merit.

The project represents a radical departure from ordinary drug studies that test treatments for single diseases. However, the group, spearheaded by Dr. Barzilai, said the Food and Drug Administration has endorsed their idea to test a single substance for effectiveness against a range of ailments.

“If metformin turns out not to work, there are several other substances in the pipeline that could be tried,” Dr. Barzilai said. “Under the auspices of the National Institute on Aging, three research centers have tested 16 substances in different animal models and got incredible results with four of them.”

Green tea, one of those tested, bestowed no health or life span benefits, despite its popularity. But the drug rapamycin, an immune modulator used following organ transplants, was most effective among those tested, Dr. Barzilai said.

The team is starting with metformin because it is a cheap oral drug — costing about two cents a pill — with six decades of safe use in people throughout the world. Among those with Type 2 diabetes who have taken it for years, there is evidence suggesting that, in addition to diabetes, it protects against cardiovascular disease, cancer and possibly cognitive impairment, Dr. Kirkland said, adding that “it targets the fundamental processes of aging, which tend to be linked.”

Dr. Barzilai said, “Our goal is to establish the principle of using a drug, or two in combination, to extend health span. The best we can expect from metformin is two or three additional years of healthy aging. But the next generation of drugs will be much more potent.”

Dr. Barzilai is already conducting a complementary study of centenarians, the results of which could identify more drugs to delay age-related diseases. He and colleagues are isolating genes that appear to keep these long-lived men and women healthy for 20 to 30 years longer than other people and shorten the length of illness at life’s end. Several studies have already found that individuals with exceptional longevity experience a compression of morbidity and spend a smaller percentage of their life being ill, Dr. Barzilai and his colleague Dr. Sofiya Milman wrote in the “Aging” book.

By analyzing the action of genes that extend health span, “it should be possible to devise drugs that mimic the genes’ effects,” he said. Two such gene-based drugs that show early promise against age-related diseases are already being tested.

But until definitive studies are completed and substances are shown to be safe as well as effective in prolonging health, Dr. Olshansky cautioned against dosing oneself prematurely with widely touted substances like resveratrol, the antioxidant found in red grapes and wine, or growth hormone.

Consumers must exercise caution, he warned, because “there’s an entire industry out there trying to market the products we’re testing before they are adequately evaluated.”

He also emphasized that taking a drug found to ward off age-related ills is not a license to abandon a healthy lifestyle. Doing so “could completely negate the benefit of a compound that slows aging,” he said.

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