WASHINGTON \u2014 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
And in The Lancet this week, an article written by two of the Food and Drug Administration\u2019s top vaccine scientists, among others, argued that there was no credible evidence that the vaccines\u2019 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\u2019s plan caught the F.D.A.\u2019s top leaders by surprise and forced the White House on the defensive.<\/p>\n
Jen Psaki, the White House press secretary, stressed on Wednesday that the administration\u2019s most senior health officials \u2014 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 \u2014 had signed a statement announcing Mr. Biden\u2019s booster plan. \u201cNothing has changed as it relates to the eight top doctors who put out that statement, almost a month ago,\u201d Ms. Psaki said.<\/p>\n
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.<\/p>\n
The F.D.A. committee will meet on Friday to discuss and vote on Pfizer-BioNTech\u2019s 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.<\/p>\n
Depending on the experts\u2019 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.<\/p>\n
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.<\/p>\n
Administration officials have started making the case that offering boosters only to older people would not be a huge change from the president\u2019s original plan. Because older adults were vaccinated first, they make up a disproportionate number of those who were vaccinated at least eight months ago.<\/p>\n
Several officials suggested that the difference from Mr. Biden\u2019s original announcement would be minimal as long as some people are offered boosters next week \u2014 even if it is only older people who received the Pfizer vaccine.<\/p>\n
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.<\/p>\n
\u201cWeeks ago, the administration decided that the public needs cake and deserves cake, and so shall have cake,\u201d he said. \u201cNow, the public expects cake and would be very annoyed if its cake was taken away at this point.\u201d<\/p>\n
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.<\/p>\n
\u201cWe just got things turned around,\u201d said Dr. Jesse L. Goodman, a former chief scientist at the Food and Drug Administration. \u201cThe 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.\u201d<\/p>\n
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\u2019s application for approval of its booster dose appear to be conforming to the timetable the administration proposed in August.<\/p>\n
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\u2019s 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.<\/p>\n
While Mr. Biden publicly noted that his strategy depended on regulatory action, he also made the plan sound all but definite. \u201cIt\u2019s simple,\u201d he said at the time. \u201cEight months after your second shot, get your booster shot.\u201d<\/p>\n
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.<\/p>\n
The data from Israel, which offered boosters first, was particularly concerning to U.S. health officials.<\/p>\n