Biden sows confusion by preempting FDA, CDC on booster shots

WASHINGTON (SBG) — The Biden administration's preemptive push to get booster shots to Americans has created confusion about the need for additional jabs while opening the White House to criticism that it is interfering in the independent operation of public health and regulatory agencies.

The Biden administration made the initial push for booster shots in mid-August, announcing that all American adults would be eligible to get another dose of vaccine starting Sept. 20. The timing of the announcement struck many health authorities as odd. Pfizer-BioNTech had just submitted clinical data to the Food and Drug Administration the day before the White House announcement, yet the administration appeared to have decided that all Americans should get the shot eight months after their last dose.

A week later, reports emerged that the White House was considering recommending boosters at six months, instead of eight.

What the administration did was "not the conventional process," explained Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University School of Medicine. He should know. Schaffner is one of the 15 members of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP), the group that has a final say on the recommended use of vaccines.

By preempting the public health institutions, the White House "got it a little backward," Schaffner noted. "It usually works in the reverse." First, the FDA receives the data from the company and reaches a conclusion about an approval, then the CDC advisory panel has a chance to weigh in on who should receive the shot and how it should be administered.

"In all candor, there were a number of eyebrows raised, my own included, when those announcements came from the White House," he said. Despite the initial confusion, Schaffer said he is confident the FDA and CDC will be rigorous in reviewing the data and making their final recommendations for use in specific populations.

Yet, some have worried that the Biden administration's mixed messaging campaign may have shaken public faith in the independence of federal regulators.

Last week, two leading officials at the FDA announced their resignation citing frustration over the agency's lack of independence in planning for boosters. Endpoints News, a biotech publication, was the first to report Marion Gruber, director of the agency’s Office of Vaccines Research and Review, and her deputy director Philip Krause were leaving the organization.

The White House later asserted that the departures would not affect public trust in the FDA. Coronavirus response director Jeffrey Zients said the agency and other leading public health officials had recommended preparing Americans for a booster.

Some have noted similarities between the Biden and Trump administrations making political pronouncements ahead of regulators and public health agencies.

Any political attempt to sideline the FDA or CDC is problematic, warned Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia a member of the FDA Vaccines and Related Biological Products Advisory Committee. But the Biden administration has not come close to the degree of interference as the previous administration.

"They didn't get ahead of the science, they just got ahead of the process," Offit said of the Biden team.

Former President Donald Trump reportedly pressured regulators and routinely sidestepped public health experts to recommend unproven treatments like hydroxychloroquine or convalescent plasma, which both had their emergency use authorizations revoked by the FDA.

So far, available evidence suggests that a third dose of an mRNA vaccine or second dose of the J&J shot increases antibodies and decreases the chance of asymptomatic or mildly symptomatic infections.

The greater risk in Biden's preemptive announcement is that it sends conflicting messages to the American public. "It sends the message that all those people who thought they were fully vaccinated aren't. That all those people who thought they were protected aren't," Offit said. "I think the message that needs to be sent now is protection against serious disease is still excellent."

According to CDC data, the Pfizer, Moderna and Johnson & Johnson shots remain highly effective in preventing hospitalization and death in people who have received the recommended doses. The delta variant has decreased vaccine efficacy slightly in preventing mild illness. Still, less than 0.01% of fully vaccinated individuals have been hospitalized with COVID-19 and deaths among the vaccinated are even less common.

Additionally, there is limited evidence that protection against serious disease is waning in either of the approved vaccines. U.S. regulators and public health officials have yet to concur with studies from Pfizer and the Israeli Health Ministry that suggested a moderate decline in vaccine efficacy at six months. Meanwhile, World Health Organization officials have urged wealthy nations to pause plans for booster shots until developing nations can close the vaccine gap.

At an ACIP meeting last week, members suggested there was not enough existing data to support the need for widespread boosters. The panel suggested it could consider risk-based recommendations depending on age and vulnerability. ACIP has already recommended a third vaccine dose for individuals with compromised immune systems and could do the same for older and more vulnerable groups, depending on the evidence.

"Protection against severe disease has continued to hold up, according to everything the CDC has presented," Offit noted. "If we move the goal post, so now the goal is to try to prevent asymptomatic or mildly symptomatic infection ... that should be clearly stated."

Recommendations by the FDA and CDC likely will not come within the timeframe initially announced by the White House. The Food and Drug Administration's vaccine advisory panel is scheduled to hold its first meeting on COVID-19 booster shots Sept. 17, just three days before the Biden administration's proposed booster start date. The panel's recommendations must then be considered by the FDA and then the CDC ACIP.

Last week, top health officials at the FDA and CDC reportedly pushed back against the White House's Sept. 20 deadline, warning they would need more time to determine whether to recommend boosters.

The Wall Street Journal reported that the process for Pfizer approval was on track but the approval for a Moderna or Johnson & Johnson booster could take several weeks. Moderna submitted its data to the FDA last week. Johnson & Johnson released initial data on the effectiveness of booster shots but has yet to submit it to federal regulators.