Both before and after the 2020 election, Joe Biden complained that President Donald Trump had politicized the Covid-19 pandemic. Biden insisted that he, in contrast with Trump, would “follow the science” and listen to the experts at the Center for Disease Control and Prevention and the Food and Drug Administration. And yet, President Biden has pushed vaccine booster shots for all adults despite opposition from the very agencies he touted as sentinels of science. Now an outside advisory panel to the FDA has overwhelmingly rejected the Biden plan, opting to recommend boosters only for a high-risk subset of those who have received the vaccine.
The administration announced plans for vaccine boosters beginning September 20 before any vaccine maker had even applied for booster approval. The first application, and thus far the only completed application ready for consideration, came from Pfizer on August 25, one week after the booster announcement. It seeks booster authorization for ages 16 and up. Pfizer’s supporting evidence was thin. Its application reported increased immune responses to the original viral variant following boosters in 317 subjects aged 18 to 55 and 12 subjects ages 65 to 85. Evidence on activity against the Delta variant that currently predominates was limited to just 11 subjects aged 18 to 55 and 12 subjects aged 65 to 85. No increase in severe adverse events related to boosters was found in the 329 subjects. Pfizer extrapolated safety and effectiveness for 16-17-year-olds from the adult data even though young males have the highest risk of heart inflammation (pericarditis/myocarditis) reported after initial vaccinations.
Politico reports that several CDC officials disagreed with the Biden administration’s booster plans, announced in mid-August. Many felt that the timetable was too rushed to allow the agency to complete studies and review vaccine manufacturer data that would justify the shots before the September 20 start date.
Two top FDA vaccine regulators, Marion Gruber and Philip Krause, announced their retirements shortly after the announcement in a move that many interpreted as a protest against the plan. Both joined with 16 other authors in a recently published Lancet article that concludes the booster policy is not supported by current evidence. They argue that vaccine efficacy remains high and that the unvaccinated remain the major drivers of transmission. Going ahead with boosters now, before adequate data and analysis are available, risks vaccine side effects that could undermine confidence in vaccines and undercut efforts to increase primary vaccinations. Moreover, they suggest that new vaccines, crafted against currently circulating variants, would likely be better boosters than administering additional doses of the original.
Other reports suggest widespread dissatisfaction among FDA staff and outside vaccine advisers who feel that White House political officials steered the announcement and cut key, career FDA employees out of the decision-making. Members of the CDC’s independent vaccine-advisory panel— the Advisory Committee on Immunization Practices (ACIP)—voiced frustration that the administration announced a plan before scientists had an opportunity to review the data and approve boosters.
Now the outside advisory panel to the FDA has voted 16–2 against recommending additional Pfizer shots for ages 16 and up. The panel did approve the booster for people 65 and older or at high risk of severe Covid-19 illness. The FDA is not obliged to follow the panel’s recommendation, but it usually does. The CDC’s ACIP will be meeting to consider boosters this week.
No one should be surprised that the Biden administration recommended boosters at the height of the Delta surge even though scientific evidence was lacking. The administration has a history of politicizing the pandemic. Candidates Biden and Kamala Harris repeatedly criticized the vaccine development under President Trump and impugned the FDA’s independence and integrity, thereby undermining public confidence in what are highly effective vaccines. The administration extended a politically popular CDC eviction moratorium after acknowledging that it lacked the legal authority to do so, only to have it struck down by the Supreme Court. Now the administration has proposed that OSHA impose workplace vaccine mandates, though it is doubtful that this step can be legally justified.
President Biden and his advisors clearly want to be seen as taking action to end the pandemic. They probably think that they are doing the right thing. But going forward, their policies should follow the science and the law.
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