Tagged Food and Drug Administration

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.

As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running

As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running

For now, the government has been relying on a patchwork of programs that officials say are hampered by limited size and gaps in data collection.

A drive-through mass vaccination site at Coors Field baseball stadium in Denver last month.
A drive-through mass vaccination site at Coors Field baseball stadium in Denver last month.Credit…Chet Strange/Agence France-Presse — Getty Images

  • Feb. 12, 2021, 5:00 a.m. ET

More than 34 million Americans have received Covid vaccines, but the much-touted system the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.

For now, federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of their small sample size, missing critical data or other problems.

Clinical trials have shown both of the vaccines authorized in the United States — one from Pfizer-BioNTech and the other from Moderna — to be highly protective and safe against the coronavirus.

But even the best trials have limited ability to detect adverse reactions that are rare, those that only occur in certain population groups, or which happen beyond the three-month period studied in the trials. Tracking adverse events once the vaccines are administered to the public at large is essential not just to detect problems but to build confidence in the safety of vaccines.

In interviews, F.D.A. officials acknowledged that a promised monitoring system, known as BEST, is still in its developmental stages. They expect it to start analyzing vaccine safety data sometime soon — but likely not until after the Biden administration reaches its goal of vaccinating 100 million people.

“I’m concerned about this disjointed tracking system,” said Dr. Ashish K. Jha, dean of the Brown University School of Public Health. “We knew these vaccines were coming for at least several months before they got authorized, so we really should have had a well-developed system.”

Dr. Jha and others believe that with all the public attention on the vaccines, any serious adverse reactions will likely be reported somewhere. But, they say, a more systematic approach is crucial.

“It’s critical to track, because it will help build confidence,” Dr. Jha said.

Monitoring is all the more important because the vaccines were developed and approved in record time, with the goal of inoculating most of the U.S. population as quickly as possible.

“It’s the right thing to do, but the fact of the matter is we don’t have enough information and we’re desperately in need of post-market information and monitoring,” said a high-ranking F.D.A. official, who asked not to be named because he was not authorized to discuss the matter publicly.

The government is now relying most on a 30-year-old safety monitoring system that the F.D.A. shares with the Centers for Disease Control and Prevention, and a new smartphone app that people who get vaccinated can download and use to report problems if they wish. The C.D.C. also runs the Vaccine Safety Datalink, a collaboration between the agency and nine health systems that collects vaccine data and electronic medical records of roughly 12 million patients. Although it is well-regarded, it is of limited use because of its small size.

Boxes of the Pfizer-BioNTech vaccine were prepared for shipment at a facility in Portage, Miich., in December.
Boxes of the Pfizer-BioNTech vaccine were prepared for shipment at a facility in Portage, Miich., in December.Credit…Pool photo by Morry Gash

“It’s great for routine stuff, but when it comes to safety surveillance, it’s all about size,” said Dr. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, and a former federal vaccine official. “The bigger it is, the faster you get an answer. Eventually the VSD will get a really good answer — probably one of the best answers of anybody out there because they are so good at doing it. But in a pandemic, time isn’t on our side.”

So far, few serious problems have been reported through these channels and no deaths have conclusively been linked to the vaccines. The 30-year-old initiative, known as the Vaccine Adverse Event Reporting System, or VAERS, relies on self-reported cases from patients and health care providers.

Health officials say that so far, the two vaccines already authorized for use appear to be quite safe. There have been a few severe allergic reactions, including anaphylaxis, but they are treatable and considered rare. The rate at which anaphylaxis has occurred so far — 4.7 cases in every million doses of the vaccine by Pfizer and BioNTech, and 2.5 cases per million for the vaccine by Moderna — are in line with what happens with other widely used vaccines.

Bruising and bleeding caused by lowered platelet counts have also been reported, though it is not known if they are linked to the vaccines, or coincidental. In total, 9,000 adverse events were reported, with 979 serious and the rest classified as nonserious, according to the most recent C.D.C. report available.

In interviews, public health experts, including current and former officials at the F.D.A. and the C.D.C., expressed a need to improve upon old “passive” surveillance, which depends on self-reporting. They said that funding shortages, turf wars and bureaucratic hurdles had slowed preparing BEST, formally called the Biologics Evaluation Safety Initiative, to monitor the Covid vaccines.

An earlier version of BEST was started in 2017, to improve the F.D.A.’s tracking of new blood products and vaccines, but the agency has only used it on a limited basis. It is considered an “active” surveillance system because scientists can use data collected from clinical care to hunt for safety problems, rather than rely on individuals to report health problems that they believe — but often without proof — were caused by the vaccine. BEST is part of the agency’s move toward using more real-world evidence to vet new products or monitor them after approval. The F.D.A. has done some preliminary studies using BEST to evaluate the safety of shingles and flu vaccines.

When the monitoring system is fully up and running, the F.D.A. expects to have access to more than 100 million individual medical records, and will be able to look for signs of safety problems, and then determine whether they are real. But critics say it is folly for the F.D.A. to be launching a new system in the midst of a pandemic. And several C.D.C. officials said the F.D.A. was not giving them a real sense of when the complex system would begin to work.

“It’s been a puzzle to me,” said one C.D.C. official who was not authorized to discuss the issue and asked not to be identified. “F.D.A. talks about this in a way that is really unclear as to what is up and ready to go and what isn’t.”

The headquarters of the F.D.A. in Silver Spring, Md.Credit…Jim Lo Scalzo/EPA, via Shutterstock

But even BEST will suffer from a data problem that is already hindering existing systems: the dearth of health insurance claims to show who got which vaccine, and when. Typically health care providers and patients submit such claims to insurers, but with the vaccines being given at no charge, often at government-sponsored events, few are bothering to file claims. Critics say that federal health officials should have predicted this glitch and prepared for it.

“The current safety surveillance system in the U.S. is dependent on health insurance claims data and electronic health records,” said Dr. Salmon. “If the vaccine data information doesn’t get into the safety system, then that safety system is unable to function.”

In December, the C.D.C. launched V-safe, a smartphone-based system that checks in with individuals who get the Covid vaccine to monitor for side effects. Roughly two million people who have been vaccinated have enrolled, a small fraction of the total number, and of those, one million have responded to text queries and surveys about their post-vaccine health.

At a recent C.D.C. advisory meeting, Dr. Tom Shimabukuro, who oversees Covid-19 vaccine safety for the agency, said he was pleased that the new app had enrolled so many users, but he also acknowledged problems like errors that indicated men and older women to be listed as pregnant.

It’s also unclear how heartily vaccine providers are promoting V-safe. Some health care providers send post-vaccine emails to patients noting its availability, and others merely put a stack of C.D.C. fact-sheets about V-safe in the vaccination room and hope patients pick it up. Even Dr. Jha said he didn’t sign up for it.

Still, Dr. Shimabukuro said he was confident in the current surveillance system. “For the national Covid-19 vaccination program, we have implemented the most intense safety monitoring in the history of the United States,” he said. “We have multiple systems that are complementary to each other, that are able to rapidly collect information, that are able to rapidly assess the safety of immunizations.”

Medical workers filled doses of Moderna’s vaccine at a a drive-through site in Robstown, Texas.Credit…Go Nakamura/Reuters

One factor slowing down BEST is that the F.D.A. has not yet calculated what are called background rates, the levels of certain health problems that normally occur in the non-vaccinated population. These are critical for determining whether the vaccine is actually causing a spike in certain problems, such as heart attacks, strokes, and other issues that the F.D.A. and C.D.C. consider adverse events of special interest, which require close monitoring.

Rather than calculate them on its own, as the C.D.C. does, the F.D.A. sent a proposal out for public comment, in which it detailed how it planned to compute the background rates. They plan to start working on it in the next few weeks. This delay strikes some public health experts as unnecessary.

“It’s a little bit surprising,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest, and a former associate commissioner at the F.D.A. “That doesn’t feel like a mechanism appropriate to the urgency of a pandemic. It seems to me that a few well-placed phone calls to key people in the field would provide as much information as a request for comment.”

Dr. Peter Marks, the director of the F.D.A.’s Center for Biologics Evaluation and Research, which oversees vaccine approval and safety, said the agency needed outside input.

“The background rates are a critical input for our rapid cycle analysis, so we followed a deliberative and transparent process,” he said in an interview. “We needed to develop an approach that could be used in several health care claims data systems and we needed to account for the possibility that health care utilization may have changed during the pandemic.”

Jeffrey Brown, an associate professor at Harvard Medical School and a leader of the F.D.A. program that monitors adverse reactions to drugs, said he is concerned about the lack of insurance claims data and other holes in the vaccine safety surveillance systems.

“It is imperative to have policies that ensure vaccination data are submitted to insurers to enable effective use of the nation’s investment in active safety monitoring,” said Dr. Brown. “It is not only critical to get needles into arms, but also to get data into databases. We still have a chance to get it done well.”

Denise Grady contributed reporting.

Credit…Jessica Hill/Associated Press

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.”

Hearing Aids Could Use Some Help

the new old age

Hearing Aids Could Use Some Help

The vital medical devices could be inexpensive and available over the counter. But efforts have stalled under the F.D.A.

Isabel Seliger

  • Dec. 14, 2020, 11:56 a.m. ET

By now, we were supposed to be swiftly approaching the day when we could walk into a CVS or Walgreens, a Best Buy or Walmart, and walk out with a pair of quality, affordable hearing aids approved by the Food and Drug Administration.

Hearing aids, a widely needed but dauntingly expensive investment, cost on average $4,700 a pair. (Most people need two.) So in 2017, Congress passed legislation allowing the devices to be sold directly to consumers, without a prescription from an audiologist. The next step was for the F.D.A. to issue draft regulations to establish safety and effectiveness benchmarks for these over-the-counter devices.

Its deadline: August 2020. A public comment period would follow, and then — right about now — the agency would be preparing its final rule, to take effect in May 2021. So by next summer, people with what is known as “perceived mild to moderate hearing loss” might need to spend only one-quarter of today’s price or less, maybe far less. And then we could have turned down the TV volume and stopped making dinner reservations for 5:30 p.m., when restaurants are mostly empty and conversations are still audible.

“These regulations are going to help a lot of people,” said Dr. Vinay Rathi, an otolaryngologist at Massachusetts Eye and Ear. “There could be great potential for innovation.”

So, where are the new rules? This long-sought alternative to the current state of hearing aid services has been delayed, perhaps one more victim of the pandemic.

Of course, the agency has other crucial matters to address just now. Although the office charged with hearing aid regulations is not the one assessing Covid-19 vaccines, an F.D.A. spokesman said via email that it was dealing with “an unprecedented volume of emergency use authorizations” for diagnostics, ventilators and personal protective equipment.

Nevertheless, “issuing the proposed rule remains a priority and we are working expeditiously to do so,” the spokesman added, providing no timetable for when that might happen.

It’s a major undertaking. The F.D.A. has never established such requirements for hearing aids, because ever since it last issued regulations, in 1977, only state-licensed providers have been allowed to prescribe and sell them — and have been presumed able to safeguard wearers. Providers and manufacturers have also kept prices high by combining testing, fitting and sales into one costly package, a practice the new law was designed to disrupt.

No other country has regulated over-the-counter hearing aids, according to Dr. Frank Lin, an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University. “We’ll be the first,” he said. “There are no performance requirements. There’s no precedent.”

But, Dr. Rathi said, “it’s not like the F.D.A. put everything else on hold.” He pointed to an array of regulations issued last month by the agency, including guidance on cross-labeling oncology medications and rules on impurities in animal drugs. “They’re still going about a lot of their regular business.”

Recently he and a colleague wrote an editorial in The New England Journal of Medicine that questioned the delay, under a pointed title, “Deafening Silence from the F.D.A.”

Senator Elizabeth Warren, Democrat of Massachusetts and Senator Chuck Grassley, Republican of Iowa, who were among the sponsors of the bipartisan 2017 law, wrote to the F.D.A. commissioner last month urging action. They noted that “despite the pandemic, hearing loss continues to be a problem for millions of Americans.” In fact, masks and distancing create greater hearing difficulties.

One-quarter of Americans in their 60s and nearly two-thirds of those over 70 have hearing loss. Its damaging consequences can include social isolation, an increased risk of falls and much higher rates of dementia.

Yet a recent analysis of federal data shows that despite modest increases, in 2018 only about 18.5 percent of Medicare beneficiaries over 70 owned and used hearing aids.

Usage was lower among women than men and far lower among Black beneficiaries than white ones; the proportion of low-income seniors using hearing aids actually declined to 10.8 percent in 2018 from 12.4 percent in 2011.

Stigma explains some of that aversion. Hearing aids can feel like “constant reminders of aging,” said Kevin Franck, director of audiology at Massachusetts Eye and Ear and an author of the New England Journal editorial. “We have people who come in who want to hide them.”

The inconvenience of multiple visits to an audiologist or technician for testing, fitting and adjustment probably also plays a role.

But expense constitutes a formidable barrier. Traditional Medicare covers testing but not hardware or other services. (It does cover cochlear implants, for those whose hearing loss grows too severe for hearing aids.) Many Medicare Advantage plans provide some hearing coverage, but beneficiaries still wind up paying 79 percent of the cost out of pocket.

“It’s the No. 1 question we get,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “‘I can’t afford hearing aids and Medicare doesn’t cover them. What do I do?’”

Advocates plan to keep lobbying Congress for Medicare coverage for hearing services and aids, included in the expansive bill H.R.3 that passed the House of Representatives last year but never came to a Senate vote.

In the meantime, over-the-counter devices retailing for several hundred dollars could make hearing aids broadly more affordable, for people or — one day, perhaps — for Medicare.

They could also solve another consumer problem, Dr. Lin added. Manufacturers can legally sell PSAPs — personal sound-amplification products that resemble hearing aids — as long as they don’t advertise them as a remedy for hearing loss. Their quality varies drastically.

The Hopkins team has been testing whether trained community health workers could help low-income seniors improve their hearing. (A pilot study indicates they can.) Their research protocol uses an effective PSAP from Sound World Solutions that retails for about $700 a pair.

But, Dr. Lin said, “most of what you see out there — ‘$50 miracle device!’ — is complete garbage. People can’t tell which to trust.”

Once federal requirements are set for over-the-counter hearing aids, however, manufacturers of quality PSAPs can apply for approval. “All the other PSAPs will go by the wayside,” Dr. Lin said. If their labels say they’re not approved by the F.D.A., “nobody will buy them, and they shouldn’t.”

Eyeing a vast and underserved market, consumer electronics companies (said to include Apple and Samsung) are standing by, along with start-ups. “There’s a lot of venture capital funding for hearing technology, once the barriers come down,” Dr. Rathi said.

Bose acted early, receiving F.D.A. clearance in 2018 for its Hearphone, which the buyer could tune with a smartphone app. But without the new rule, state restrictions would have prevented national sales, so Bose didn’t market it.

The company is working on a new over-the-counter product, however. “We’re cautiously optimistic that 2021 will be the year,” said Brian Maguire, director of the Bose Hear group.

Once the F.D.A. acts and companies and retailers ramp up, expect new products and advertisements to pop up in stores and online. “We’ll have a bit of a Wild West period,” Ms. Kelley said. “People are going to be confused. They’re going to need a lot of information.”

At that point, audiologists will no longer serve as exclusive gatekeepers to hearing aids. But they can still render important services: testing, education and counseling, adjusting devices — even if clients bought them elsewhere.

“Wearing something comfortably in your ear all day, day after day, is a challenge,” Dr. Franck said. “You want it customized. If you hear echoes or feedback, audiologists know a lot about those issues.”

But the country has only about 18,000 audiologists, Ms. Kelley pointed out. Particularly in rural areas, people with hearing loss might need to drive hours to find one.

But a supermarket? A big box store? A pharmacy? A website? Almost everyone can get to one of those.

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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


  • 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.

Don’t Eat Raw Dough, F.D.A. Cautions


Credit iStock

Maybe you’ve swiped a bite of raw cookie dough while preparing a batch to bake. Or perhaps you’ve let your children lick the batter from the cake bowl, or use homemade “play dough” to make crafts. But even if the dough is free of raw eggs, which you think might give you a pass, don’t eat it.

Yesterday, the Food and Drug Administration issued a message warning people not to eat raw dough because of a recent outbreak of E. coli linked to contaminated flour.

So far, a reported 38 people in 20 states have been infected by a strain of bacteria called Shiga toxin-producing E. coli O121 found in flour. The infections began last December, and 10 of those infected have been hospitalized.

Symptoms of the bacterial infection include severe stomach cramps, diarrhea (often bloody), and vomiting. Most people get better within a week, but in some cases, infections can lead to a type of kidney failure called hemolytic uremic syndrome. Those who are most vulnerable to severe illness include children under 5, older adults and people with weakened immune systems.

Investigations by the Centers for Disease Control and Prevention and the F.D.A. traced the source of the outbreak to flour that was produced in November 2015 at the General Mills facility in Kansas City, Mo. General Mills has issued a voluntary recall of 10 million pounds of flour produced between Nov. 14 and Dec. 4, sold under three brand names: Gold Medal, Signature Kitchens and Gold Medal Wondra. Flour that is part of the recall should be thrown away.

Unlike other raw foods, like eggs or meat — which many people recognize as contamination risks — “flour is not the type of thing that we commonly associate with pathogens,” said Jenny Scott, a senior adviser in the F.D.A.’s Center for Food Safety and Applied Nutrition.

In this case, investigators believe that the grain became contaminated in the field, where it is exposed to manure, cattle, birds and other bacteria. “E. coli is a gut bug that can spread from a cow doing its business in the field, or it could live in the soil for a period of time; and if you think about it, flour comes from the ground, so it could be a risk,” said Adam Karcz, an infection preventionist at Indiana University Health in Indianapolis.

Normally, flour is cooked before it is consumed, destroying any pathogens. “For the most part, the risk from flour is pretty low, and most use of flour involves a ‘kill step’ — people bake with it,” Ms. Scott said. In commercial uses like “raw” cookie-dough ice cream, companies generally heat-treat it to eliminate bacteria, she said.

Consumers, then, need to be aware that they should follow food safety guidelines for flour. That means washing your hands thoroughly before and after handling raw flour. And Ms. Scott warned against letting children play with homemade play dough. “Kids are going to handle it and touch their faces, and they’re going to lick their fingers; it’s hard to supervise that,” she said.

At home, Mr. Karcz suggests sealing your flour container and storing it in a cool, dry place to prevent contamination. And after using flour, be sure to clean up your countertops, cutting boards and utensils to prevent the spread of any bacteria.

If you do develop symptoms of infection, contact your health care practitioner for treatment and to report the illness, particularly if you suspect it’s connected to an outbreak.

“We want to encourage consumers to report their illnesses, even though it’s an imperfect system,” Ms. Scott said. “We’d like to have the tests done and get everything reported and identify these outbreaks so we can follow up, discover root causes and make changes in the system so that people don’t get sick in the future.”