Booster Confusion

UC (and UCLA) now require faculty, staff, and students to be fully vaccinated. However, the White House report that booster shots may be needed potentially adds to the complexity of what that requirement might mean. Yours truly has reports that individuals with compromised immune systems are already receiving notices from UCLA Health to get a third shot. But from the NY Times comes a report that the three-shot recommendation may or may not occur beyond those with compromised immune systems:

U.S. Booster Policy Is in Flux as Studies Add to Dissent

A week before President Biden’s plan is to roll out, scientists are at odds about whether extra coronavirus shots are needed and for whom.

By Sharon LaFraniere and Noah Weiland, Sept. 15, 2021

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 it 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.

Source: https://www.nytimes.com/2021/09/15/us/politics/booster-shots-fda.html.