F.D.A. Panel’s Vote on Covid Boosters Sets Biden Plan Back

The panel recommended against blanket access to Pfizer boosters for those 16 and older, but urged offering them to those 65 and older and “at high risk,” a term that offers the White House some room to expand access.

Advertisement

Continue reading the main story

An F.D.A. panel’s vote deals the Biden administration’s push for universal booster shots a setback.

President Biden speaking in Washington on Aug. 23, when the Food and Drug Administration gave the Pfizer-BioNTech shots full approval, a first for a Covid vaccine. Credit…Doug Mills/The New York Times

By Ron DePasquale

Sept. 18, 2021, 10:32 a.m. ET

The Biden administration’s push to make Covid-19 booster shots available to most fully vaccinated adults has been stymied for now by a Food and Drug Administration advisory panel’s recommendation that Pfizer boosters be made available only to those 65 and over and those at high risk of severe Covid.

However, the roiling debate over whether the shots are needed more broadly remains unsettled.

The panel of experts on Friday overwhelmingly voted not to recommend boosters for those over 16 after a tense, daylong debate that put divisions within the agency and the administration on public display.

The vote was a blow to President Biden, strengthening criticism of his effort to enhance the immunity of already vaccinated Americans at a time when most residents of poor nations have not even had first doses. The F.D.A. and the Centers for Disease Control and Prevention authorized third shots for some immunocompromised individuals more than a month ago, on the ground that the additional dose would simply lift their protection to the level other people achieve with two shots.

Some F.D.A. experts said that the data from Pfizer and elsewhere still seemed to show that two shots protected against severe disease or hospitalization for months afterward, and that there was not enough evidence that a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.

The panel’s final recommendations left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably be deemed eligible for additional shots of the Pfizer vaccine. And a small but growing number of people have stopped waiting for federal authorization and are finding ways to receive booster shots.

Before the panel met on Friday, the Centers for Disease Control and Prevention released data indicating that, for some people, the level of protection against Covid hospitalizations afforded by the Pfizer-BioNTech vaccine dropped significantly four months after full inoculation.

The C.D.C. study supported some others that suggest the Pfizer vaccine may offer less protection from hospitalization over time. The available data is far from unanimous, though so far it suggests that only older adults will need boosters. Participants in the C.D.C. study skewed older and it was unclear if the same waning of vaccine effectiveness happened among younger vaccinated people.

Understand Vaccine and Mask Mandates in the U.S.

Vaccine rules. On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.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. Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots. Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.

Other studies have shown that Pfizer’s effectiveness against hospitalization has remained above 90 percent, despite the rapid spread of the Delta variant and the passage of time. Pfizer has said that data from Israel suggests a falling effectiveness against severe disease, though it appears that Israel and the United States define “severe disease” differently.

The debate is playing out as the Delta variant continues ravaging less-vaccinated areas of the country. New coronavirus cases and Covid hospitalizations across the United States have started to show signs of decline, although they remain far higher than they were earlier in the summer. And the average number of daily deaths has been increasing since early July, from this year’s low of 175 to nearly 2,000 by the end of this week, according to a New York Times database. About one in every 500 Americans has died from the disease.

The pace of vaccinations remains relatively sluggish. Providers are administering about 775,000 doses per day on average, according to federal data, a fraction of the April peak but still more than 250,000 higher than the low point in July. About 54 percent of Americans are fully vaccinated, according to a New York Times database, the second lowest proportion among the Group of 7 wealthy nations — but Japan’s now aggressive vaccination campaign is likely to leave the United States last among the G-7 shortly.

The F.D.A. has the final word on vaccine approvals, and while it is not obliged to follow the advisory committee’s recommendations, it typically does. The agency will likely issue a decision on boosters by early next week.

Leave a Reply