F.D.A. Panel Recommends Moderna Booster for Certain Groups
Those eligible for the extra shot would include adults over 65 and others at high risk — the same groups now eligible for a Pfizer-BioNTech boost,
F.D.A. Panel Recommends Booster for Many Moderna Vaccine Recipients
Those eligible for the extra shot would include adults over 65 and others at high risk — the same groups now eligible for a Pfizer-BioNTech boost
WASHINGTON — A panel of independent medical experts on Thursday unanimously recommended Moderna booster shots for many of those who had received the company’s coronavirus vaccine, paving the way to sharply expand the number of people eligible for an additional shot in the United States.
The advisory panel to the Food and Drug Administration voted 19 to 0 in favor of emergency authorization of a half-dose booster, at least six months after the second dose. Those eligible for the extra shot would include people over 65 and other adults considered at high risk — the same groups now eligible for a Pfizer-BioNTech booster.
The F.D.A. typically follows the panel’s advice, and should rule within days.
The recommendations come as the nation is seeing a decline in coronavirus cases but still faces nearly 90,000 new infections and roughly 1,800 deaths per day. The Biden administration has cast booster shots as an additional tool in the battle against the pandemic, while acknowledging that controlling the disease’s spread depends upon vaccinating tens of millions of Americans for the first time.
In a speech at the White House on Thursday, President Biden once again sought to rally businesses to support vaccination mandates that he said would help reduce the ranks of the unvaccinated in the United States, calling the number of people who have not gotten even a first shot “unacceptably high.” Mr. Biden encouraged Americans to seek out booster shots when they become eligible, calling them “free, available and convenient.”
More than seven million people in the United States have already obtained booster doses of the Pfizer-BioNTech vaccine, and more than a million have received third doses of Moderna’s, even though only those with immune deficiencies are officially eligible.
Thursday’s vote was considerably smoother than the one the panel held last month, after a chaotic and at times acrimonious debate on whether the F.D.A. should authorize booster shots for Pfizer-BioNTech recipients.
On Friday, the same expert committee will meet to discuss and vote on whether the roughly 15 million people who received the single-dose Johnson & Johnson vaccine should also be eligible for booster doses. Its members are also supposed to discuss a new federal study that suggests those Americans might be better off getting a booster dose of the Moderna or Pfizer-BioNTech vaccines.
If the F.D.A. quickly authorizes Moderna booster doses, and if the Centers for Disease Control and Prevention signs off after a meeting of its own committee of vaccine experts next week, people in the eligible groups could begin seeking out the shots soon after. In addition to people over 65, those groups include younger adults at high risk of severe Covid-19 or serious complications because of medical conditions or their jobs.
Some committee members on Thursday decried the lack of more robust data justifying a booster. Dr. Archana Chatterjee, an infectious disease expert at Rosalind Franklin University, pointed out that cases were already declining here without widely available booster doses.
Other members said that the F.D.A. had set a precedent by authorizing additional shots for many recipients of the Pfizer-BioNTech vaccine, making it hard to deny vulnerable Americans who received the Moderna vaccine a chance to receive a booster.
“From a pragmatic point of view,” said Dr. Stanley Perlman of the University of Iowa, a committee member, “because we’ve already approved it for Pfizer, I don’t see how we can possibly not approve it for Moderna.”
To date, more than 103 million people in the United States have been fully vaccinated with Pfizer’s product, more than 69 million with Moderna’s and about 15 million with the Johnson & Johnson shot.
Dr. Patrick Moore, a panel member and virologist at the University of Pittsburgh, said he voted to recommend a Moderna booster based on a “gut feeling, rather than based on really, truly serious data.” Others questioned whether half a dose was the right amount, and whether a Moderna booster would work better if it was given at least eight months after the second shot, instead of six months.
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“I’m not sure we have actually identified the optimal regimen for these vaccines,” said Dr. Michael Kurilla, an infectious disease expert at the National Institutes of Health.
The panel made clear it did not favor expanding eligibility for booster shots beyond the higher-risk groups that qualify for Pfizer boosters. No vote was taken on that question, but the committee expressed concern that booster eligibility decisions could become a slippery slope.
Several experts said they were worried about recommending additional shots based on clinical trial results from just a few hundred participants.
“I’m not sure that we want to just explore it willy-nilly by giving it to a lot of people,” said Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.
Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said the agency’s experts would take the panel’s concerns to heart in considering whether younger adults without significant risk factors should become eligible for boosters. The agency “heard pretty loud and clearly that there was not a lot of appetite for moving down the age range very significantly, if at all,” he said.
State health officials say that the staggered rollout of boosters has left some especially vulnerable people — for example, elderly residents of nursing homes who got the Moderna vaccine — in the lurch. But some panel members said on Thursday that nearly two months after the Biden administration announced its booster plan, the rationale remained vague.
The State of Vaccine Mandates in the U.S.
Vaccine rules. On Aug. 23, the F.D.A. granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for mandates in both the public and private sectors. Such mandates are legally allowed and have been upheld in court challenges.College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.Schools. California became the first state to issue a vaccine mandate for all educators and to announce plans to add the Covid-19 vaccine as a requirement to attend school, which could start as early as next fall. Los Angeles already has a vaccine mandate for public school students 12 and older that begins Nov. 21. New York City’s mandate for teachers and staff, which went into effect Oct. 4 after delays due to legal challenges, appears to have prompted thousands of last-minute shots.Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get vaccinated. Mandates for health care workers in California and New York State appear to have compelled thousands of holdouts to receive shots.Indoor activities. New York City requires workers and customers to show proof of at least one dose of the Covid-19 for indoor dining, gyms, entertainment and performances. Starting Nov. 4, Los Angeles will require most people to provide proof of full vaccination to enter a range of indoor businesses, including restaurants, gyms, museums, movie theaters and salons, in one of the nation’s strictest vaccine rules.At the federal level. On Sept. 9, President Biden announced a vaccine mandate for the vast majority of federal workers. This mandate will apply to employees of the executive branch, including the White House and all federal agencies and members of the armed services.In the private sector. Mr. Biden has mandated that all companies with more than 100 workers require vaccination or weekly testing, helping propel new corporate vaccination policies. Some companies, like United Airlines and Tyson Foods, had mandates in place before Mr. Biden’s announcement.
“I just worry that we haven’t clearly defined what the goal” is, said Dr. Paul Offit, an infectious disease expert with the Children’s Hospital of Philadelphia. Declining levels of neutralizing antibodies and eroding protection against mild or asymptomatic infection are “inevitable,” he said, adding that aiming to prevent even mild cases “is a high bar to which we hold no other vaccine.”
Although the F.D.A. took no official stance on Moderna’s request for booster authorization, some agency officials made a general case for booster shots to the committee. Dr. Marks said the vaccines’ effectiveness against mild and moderate disease appears to wane over time, and that even less severe cases of Covid-19 might lead to long-lasting symptoms and other health consequences.
Overall, Moderna officials did not make as strong a case for extra shots as Pfizer last month.
Moderna’s potency has held up better than Pfizer’s over time. Unlike Pfizer, the company did not contend that recipients of its vaccine needed a booster to prevent severe disease or hospitalization, instead concentrating its arguments on preventing infection.
Moderna met one of the F.D.A.’s criteria for a booster shot, reporting that the mean antibody level of participants in its study was 1.8 times as high after the booster than it was after the second shot. But it narrowly failed to meet another requirement. It raised neutralizing antibodies at least fourfold in 87.9 percent of people compared to after the second dose, while the agency required that level of boost for 88.4 percent of participants.
Some experts questioned whether Moderna had gathered enough data on potential side effects. Regulators and scientists have been especially concerned about the risks of the heart conditions myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the lining around the heart.
The F.D.A. in June attached warnings about those risks to the Pfizer-BioNTech and Moderna vaccines, and officials on Thursday cited an elevated risk in men between 18 and 25 who were fully vaccinated with either Moderna or Pfizer-BioNTech.
A key part of Thursday’s discussion revolved around Israel’s booster campaign for the Pfizer-BioNTech vaccine. The Biden administration has been closely watching Israel’s experience, because the country has a nationalized health care system that allows it to closely track vaccine recipients.
A top Israeli health official told the committee that her government’s booster campaign had changed the course of the pandemic there. She said Israel saw dramatically lower rates of both infection and severe disease among those who received a booster shot compared to those who had not. It was not clear, though, whether other factors, such as the decline of the Delta variant, also had an effect.
Dr. Mark Sawyer, a professor in the School of Medicine at University of California San Diego, said even though the Moderna vaccine was different, Israel’s data was compelling.
But Dr. Kurilla of the National Institutes of Health questioned whether Israel’s booster campaign deserved so much credit, noting that the nation’s latest drop in infection rates seemed to fit in with previous waves of the virus.
He asked Dr. Sharon Alroy-Preis, Israel’s director of public health services, whether she believed that a third injection of Pfizer’s vaccine would extend protection for a long time, or whether “you’ll be back in another six months” for another booster.
Dr. Alroy-Preis noted that some vaccines offer protection for years after a booster shot. Whether that is true of coronavirus vaccines, she said, is “the million-dollar question.”