FDA clears coronavirus booster shots for all adults

WASHINGTON – The Food and Drug Administration Friday booster injections allowed Pfizer-BioNTech and Moderna vaccines for all people 18 years of age and over, opening eligibility to tens of millions of fully vaccinated adults.

The move simplifies eligibility, fulfills President Biden’s commitment to offer the injections to every American adult, and officially authorizes a practice already in place in at least 10 states. Fearing that waning protection and the onset of winter would trigger a wave of groundbreaking infections, a growing number of governors had already offered reminders to everyone 18 and over before the holidays.

The agency said the expansion was justified by currently available clinical trial data as well as real-world evidence. In a statement, Dr Peter Marks, who heads the FDA’s division that regulates vaccines, added: Booster dose and make sure booster doses are available to anyone who might need them.

Dr.Anthony S. Fauci, the federal government’s foremost infectious disease expert, has been a tireless advocate over the past month for booster shots for all adults, a position shared by most other health advisers. by Mr. Biden. Public health experts who argue healthy young adults don’t need it, he said, ignore the risks of symptomatic Covid-19.

“Enough is enough. Let’s move on here,” he said at an event on Wednesday night. “We know what the data is. “

If the Centers for Disease Control and Prevention agrees, all adults who received a second injection of Pfizer or Moderna at least six months ago will most likely be able to receive a booster injection by the weekend. The agency’s external advisers are meeting to discuss the matter at noon Friday and will hear from staff from Pfizer, Moderna and CDC. A vote is scheduled at 2:45 p.m.

In a White House briefing on Wednesday, CDC director Dr Rochelle Walensky pledged that the agency “will quickly review the safety and efficacy data and make recommendations as soon as we hear from the drug. FDA ”.

The FDA’s action came after months of fierce debate within the administration and the scientific community over who needed recalls and when. While large studies showed protection against all three federally licensed vaccines to be strong, some outside FDA and CDC advisers have repeatedly expressed unease at the speed with which the administration is moving to deliver. vaccines.

While the FDA has been evaluating data from boosters for months, it has responded to requests from companies with remarkable speed. Pfizer-BioNTech filed its application about 10 days ago and Moderna announced on Wednesday that it had applied but did not specify when.

The agency said it did not convene its independent vaccine advisory committee because the panel had previously discussed the use of booster vaccines extensively and “the requests do not raise questions that would benefit from ‘further discussion “. The recommendations of the panel are not binding.

For Moderna, the regulators said, the data showed that 149 clinical trial participants who received a booster dose had higher antibody levels than 1,055 study volunteers who received only two doses. They said Pfizer data for 200 participants in a clinical trial showed the booster increased antibody levels compared to a month after a second stroke.

Critics said the administration’s recall campaign was motivated by practical or political reasons more than scientific. Some have said federal regulators are analyzing safety and efficacy data on the fly. Others fear that removing the Pfizer and Moderna booster doses for all adults may inadvertently undermine the vaccines and suggest that two doses are not strongly protective.

“There is no evidence that a large deployment of boosters is really going to have as much of an impact on the epidemic,” said Ira M. Longini Jr., vaccine expert and professor of biostatistics at the University of Florida. He said the booster doses could increase protection at least temporarily and could help a nervous public feel like they have another tool in the pandemic, but would do little to stop the transmission of the virus. virus, which is caused by the unvaccinated.

Other public health experts have argued that data from Israel, which launched an aggressive recall campaign over the summer, suggests that boosters may reduce rates of transmission; they say the additional shots are needed both to counter the decline in protection and to limit confusion.

Complex eligibility rules associated with the government’s recent decision to let people choose among the three vaccines for their recall also left the public somewhat perplexed, supporters of the FDA decision said on Friday.

“This FDA decision is long overdue,” said Dr. Elizabeth McNally, director of the Center for Genetic Medicine at the Feinberg School of Medicine at Northwestern University.

“A lot of people have had a hard time figuring out whether or not to receive reminders,” she said in a statement. “This message is much clearer: get a reminder! “

There is near universal agreement among federal officials, state health officials, and outside scientists that persuading the tens of millions of Americans who have yet to receive their first injection should remain the top priority in trying to curb the pandemic.

More than 182 million adults in the United States, or 71 percent, are fully immunized. So far, more than 32 million of them have received an additional injection.

To date, those eligible for recalls have included people 65 years of age and older, residents of long-term care facilities, people with underlying medical conditions, and those whose employment or conditions of care. life in institutions increased their risk.

All recipients of the Johnson & Johnson single injection vaccine have already been cleared for a booster injection at least two months after their injection.

Jason L. Schwartz, associate professor of health policy at the Yale School of Public Health, said the latest move was “an acknowledgment that the current approach to recall recommendations just isn’t working.”

“It’s so confusing that I think the public kind of shrugged their shoulders at the importance of boosters,” he said. “And the groups that it’s really important to get reminders for – the elderly, long-term care residents, people with medical conditions – aren’t getting reminders at the rates they should. It’s time for a reset.

The booster rollout expands even as public health experts continue to question whether healthy young adults need additional protection. The argument is stronger for recipients of Pfizer’s vaccine than for recipients of Moderna, whose protection has been shown to be more durable.

While some studies have shown that the effectiveness of the Pfizer vaccine against infections and hospitalizations decreased about four months after the second dose, the effectiveness of Moderna has remained more stable.

At the same time, regulators have been concerned about data from the Nordic countries and beyond suggesting that young men receiving Moderna may face increased risks of myocarditis or inflammation of the heart muscle – a side effect that also has been linked to the Pfizer vaccine. The FDA updated the vaccine on Friday files It should be noted that some studies have suggested that there may be an increased risk in men under the age of 40 “compared to other authorized or approved Covid-19 mRNA vaccines”.

The regulators said that although the data are limited, the evidence suggests a lower risk of myocarditis after the booster doses than after the second doses of the injection. Concerns about myocarditis prompted the FDA’s decision to wait to approve the Moderna vaccine for adolescents.

Scientists said the absolute risk is still very low, most cases are mild and resolve quickly, and Covid-19 can also trigger myocarditis.

The FDA said on Friday that by reviewing the broader eligibility of recalls for Moderna and Pfizer’s vaccines, it looked at recent virus cases and actual data on myocarditis risks and concluded that the benefits of a recall outweighed the risks. The FDA also noted that the two companies were conducting additional studies on the risk of myocarditis.

At the heart of the recall debate is the question of what vaccines are supposed to do. Critics of administration policy argue that despite some declining degree of protection, vaccines still serve their purpose of protecting against serious illness and hospitalization.

Booster advocates like Dr Fauci counter that vaccines should also protect against symptomatic illnesses, especially since some patients avoid hospitalization but suffer long-term consequences.

“I don’t know of any other vaccine that we only care about keeping people out of hospitals,” Dr Fauci said in a White House briefing Wednesday. “I think that an important thing is to prevent people from contracting symptomatic illnesses,” including younger ones.

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.

Many other countries have taken the same approach, including Australia, Brazil, Canada, Germany, Hungary, Israel, Japan, Norway, and Saudi Arabia. European Union regulators have authorized booster doses of both Modern and Pfizer-BioNTech for all adults.

Kitty bennett contributed research.