WASHINGTON – The FDA on Friday authorized Pfizer-BioNTech and Moderna booster vaccines for all people age 18 and older, opening the eligibility for tens of millions of fully vaccinated adults.
Moderna and Pfizer announced that regulators have extended approval for their booster vaccines.
The move simplifies eligibility, fulfills President Biden’s promise to offer shots to every American adult, and formally authorizes a practice that already exists in at least 10 states. Fearing that weakening defenses and the onset of winter would trigger a wave of breakthrough infections, a growing number of governors were already offering boosters for everyone 18 and older ahead of the holidays.
Dr. Anthony S. Fauci, the federal government’s chief infectious disease expert, has been relentlessly advocating revaccination for all adults over the past month, a position shared by most of Mr. Biden’s other health advisors. Dr. Fauci said the drop in antibody levels in fully vaccinated people was a clear sign that revaccinations were needed. Public health experts who claim healthy young people don’t need them are ignoring the risks of symptomatic Covid-19, he said.
“Enough is enough. Let’s move on,” he said at an event on Wednesday night… “We know what this data is.”
If the Centers for Disease Control and Prevention agrees, all adults who received a second Pfizer or Moderna shot at least six months ago are likely to be eligible for a weekend booster shot. A meeting of the agency’s external advisers is scheduled for Friday.
At a White House briefing on Wednesday, CDC Director Dr. Rochelle Walenski promised the agency “will quickly review the safety and efficacy data and make recommendations as soon as we hear from the FDA.”
The FDA’s action came after months of bitter debate within the administration and the scientific community about who needs boosters and when. Several FDA and CDC third-party advisors have repeatedly expressed dissatisfaction with how quickly the administration has been proposing injections. Critics said the administration’s vigorous campaign was motivated by practical or political reasons rather than scientific ones, and that federal regulators analyzed safety and efficacy data on the fly.
“There is no evidence that widespread adoption of boosters will actually have such a profound effect on the epidemic,” said Ira M. Longini Jr., a vaccine expert and professor of biostatistics at the University of Florida. He said booster doses could increase someone’s defenses, at least temporarily, but would do little to stop the transmission of the virus that is driven by the unvaccinated. For a nervous public, he said, booster shots may seem like a quick and easy way to contain the virus. But he echoed the often-stated stance by administrations that convincing the unvaccinated to get vaccinated should remain a top priority.
Other public health experts have argued that the government needs to offer boosters for all adults to avoid confusion. The complicated selection rules, they said, combined with a recent government decision to allow people to choose from all three vaccines for their revaccination.
“This decision by the FDA is overdue,” said Dr. Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern University’s Feinberg School of Medicine.
“A lot of people can’t figure out if they should or shouldn’t receive boosters,” she said in a statement. “This message is much clearer – get a booster!”
Until now, people 65 years of age and older, residents of long-term care facilities, people with underlying medical conditions, and those whose work or living conditions in institutions increased their risk were eligible for revaccination.
All Johnson & Johnson single-dose vaccine recipients have already received approval to revaccinate at least two months after injection.
Jason L. Schwartz, associate professor of health policy at the Yale School of Public Health, said the latest approvals were “an acknowledgment that the current approach to revaccination guidelines just doesn’t work.”
“It’s so confusing that I think the public kind of shrugged their shoulders about the importance of boosters,” he said. “And the groups for whom it is really important to get boosters – the elderly, long-term care patients, people with medical conditions – are not getting boosters as quickly as they should. It’s time to reboot. “
Booster adoption is expanding, even as public health experts continue to debate whether young, healthy adults need additional protection. This argument is stronger for recipients of the Pfizer vaccine than for recipients of the Moderna vaccine, which proved to be significantly more potent.
What you need to know about Covid vaccines and boosters
While some studies have shown that the effectiveness of the Pfizer vaccine against infection and hospitalization declines approximately four months after the second dose, the effectiveness of Moderna remains more stable.
At the same time, regulators were alarmed by data from the Nordic and other countries suggesting that young male Moderna recipients may face an increased risk of myocarditis or inflammation of the heart muscle – a side effect also associated with the Pfizer vaccine. The scientists stated that the absolute risk is still very low, most cases are mild and resolved quickly, and that Covid-19 can also cause myocarditis.
Concerns about myocarditis prompted the FDA to delay approval of the vaccine for adolescents.
At the heart of the revaccination debate is the question of what vaccines should do. Critics of the administration’s policy argue that, despite some weakening of protection, vaccines continue to fulfill their mission of protecting against serious illness and hospitalization.
Booster proponents like Dr. Fauci argue that vaccines should also protect against symptomatic illness, especially as some patients avoid hospitalization but suffer long-term consequences.
“I don’t know of any other vaccine that we are only concerned about keeping people out of hospitals,” Dr. Fauci said at a White House briefing on Wednesday. “I think that it is important to prevent the appearance of symptomatic diseases in people, including young people.
In recent weeks, state after state has moved to allow booster shots for all adults, including Massachusetts, Rhode Island, Kansas, Kentucky, Maine, Vermont, Arkansas, California, Colorado, and New Mexico.
Numerous other countries have used the same approach, including Australia, Brazil, Canada, Germany, Hungary, Israel, Japan, Norway, and Saudi Arabia. European Union regulatory bodies have authorized revaccinations of both Moderna and Pfizer-BioNTech for all adults.
Kitty Bennett contributed to the research.