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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.”

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.”

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.