WASHINGTON — Almost a month ago, President Biden announced a plan to make coronavirus booster shots available to most adults in the United States eight months after they received their second dose. But a week before the plan is to roll out, its contours are up in the air amid a chorus of dissent inside and outside the government.
The White House has already been forced to delay offering boosters to recipients of the Moderna vaccine, and for now it is planning third shots only for those who received the Pfizer-BioNTech vaccine. Depending on what two public health agencies decide in the coming days, the administration may have to change course again, perhaps restricting extra shots to older Americans and others who are particularly vulnerable to serious illness.
A series of dueling reviews this week illustrated the fierce argument among scientists about whether boosters are needed, and if so, for whom. A study released on Wednesday in The New England Journal of Medicine appears to bolster the case made by the White House and its senior health advisers, stating that those who received a third shot of the Pfizer vaccine in Israel were far less likely to develop severe Covid than those who received two injections.
But a review by regulators at the Food and Drug Administration, also made public on Wednesday, looked at broader evidence on third doses of the Pfizer vaccine and raised caveats.
And in The Lancet this week, an article written by two of the Food and Drug Administration’s top vaccine scientists, among others, argued that there was no credible evidence that the vaccines’ potency against severe disease declined substantially over time. The two scientists had announced that they would leave the agency this fall, but their public opposition to the administration’s plan caught the F.D.A.’s top leaders by surprise and forced the White House on the defensive.
Jen Psaki, the White House press secretary, stressed on Wednesday that the administration’s most senior health officials — including Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention — had signed a statement announcing Mr. Biden’s booster plan. “Nothing has changed as it relates to the eight top doctors who put out that statement, almost a month ago,” Ms. Psaki said.
What comes next partly depends on crucial meetings of expert advisory committees to both the F.D.A., which is responsible for authorizing vaccines, and the C.D.C., which typically has the final word on vaccination policies.
The F.D.A. committee will meet on Friday to discuss and vote on Pfizer-BioNTech’s application to offer third shots to people 16 and older. The C.D.C. panel is expected to meet next week. Agency officials are not required to follow the recommendations of their outside expert panels, but they generally do so.
Depending on the experts’ reaction to the data review that F.D.A. regulators posted on Wednesday, the agency could decide to scale back an authorization. Even if the Food and Drug Administration approves the application as it currently stands, however, the C.D.C. might recommend boosters only for those 65 and older or others who are particularly at risk, according to people familiar with the discussions.
The plan to start offering extra shots next week was announced when the White House was under growing pressure to move on boosters. Because of the highly contagious Delta variant, hospitalizations and deaths were soaring, albeit largely among the unvaccinated. Breakthrough infections were becoming more common. France, Germany and Israel were moving faster than the United States to offer boosters. And several governors were publicly calling on Mr. Biden to follow suit.
Understand the Infrastructure Bill
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- One trillion dollar package passed. The Senate passed a sweeping bipartisan infrastructure package on Aug. 10, capping weeks of intense negotiations and debate over the largest federal investment in the nation’s aging public works system in more than a decade.
- The final vote. The final tally in the Senate was 69 in favor to 30 against. The legislation, which still must pass the House, would touch nearly every facet of the American economy and fortify the nation’s response to the warming of the planet.
- Main areas of spending. Overall, the bipartisan plan focuses spending on transportation, utilities and pollution cleanup.
- Transportation. About $110 billion would go to roads, bridges and other transportation projects; $25 billion for airports; and $66 billion for railways, giving Amtrak the most funding it has received since it was founded in 1971.
- Utilities. Senators have also included $65 billion meant to connect hard-to-reach rural communities to high-speed internet and help sign up low-income city dwellers who cannot afford it, and $8 billion for Western water infrastructure.
- Pollution cleanup: Roughly $21 billion would go to cleaning up abandoned wells and mines, and Superfund sites.
Administration officials have started making the case that offering boosters only to older people would not be a huge change from the president’s original plan. Because older adults were vaccinated first, they make up a disproportionate number of those who were vaccinated at least eight months ago.
Several officials suggested that the difference from Mr. Biden’s original announcement would be minimal as long as some people are offered boosters next week — even if it is only older people who received the Pfizer vaccine.
John P. Moore, a virologist at Weill Cornell Medicine, said that the White House was under political pressure after declaring that boosters were necessary and that they would be available next week pending regulatory approval.
“Weeks ago, the administration decided that the public needs cake and deserves cake, and so shall have cake,” he said. “Now, the public expects cake and would be very annoyed if its cake was taken away at this point.”
The backpedaling is a result of what some describe as a double mistake by the White House: First, officials pinpointed a specific week when additional shots would be rolled out. Second, they announced a broad plan covering the Pfizer and Moderna vaccines before regulators had time to review or even gather all the necessary data.
“We just got things turned around,” said Dr. Jesse L. Goodman, a former chief scientist at the Food and Drug Administration. “The administration and the leaders of the scientific agencies who signed on got out in front of any public discussion, airing of the data or vetting of it. That put the F.D.A. and the C.D.C. and their advisory committees in a corner.”
Dr. Woodcock, the acting F.D.A. commissioner, privately warned that it was risky to announce a timetable, especially for multiple vaccines, according to people familiar with the discussions. The F.D.A. and the C.D.C. meetings in the coming days and Pfizer’s application for approval of its booster dose appear to be conforming to the timetable the administration proposed in August.
Like other senior health officials, Dr. Woodcock had hoped that booster shots could be offered this month not only for Pfizer and Moderna recipients, but for recipients of Johnson & Johnson’s one-dose vaccine as well, according to people familiar with the deliberations. But the administration had to limit its plan to Pfizer recipients, officials said, because neither Moderna nor Johnson & Johnson delivered the expected data in time.
While Mr. Biden publicly noted that his strategy depended on regulatory action, he also made the plan sound all but definite. “It’s simple,” he said at the time. “Eight months after your second shot, get your booster shot.”
In interviews, senior administration officials defended the decision to specify a date for the rollout, saying that precious time would have been lost if pharmacies, providers and state officials were not prepared.
The data from Israel, which offered boosters first, was particularly concerning to U.S. health officials.
Understand Vaccine and Mask Mandates in the U.S.
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- 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.
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