It’s been a murky first few days of September for the Biden Administration regarding COVID-19 booster shots. The latest development came in a Sept. 3 story in which two top federal health officials advised the White House to scale back its booster shot plan, as regulators need more time to collect and review data.
As the New York Times reported, Food and Drug Administration acting commissioner Dr. Janet Woodcock and Centers for Disease Control and Prevention director Dr. Rochelle Walensky warned about needing more time and data to determine whether some or all of Pfizer-BioNTech vaccine recipients would need boosters.
White House spokesperson Chris Meagher noted, “We always said we would follow the science, and this is all part of a process that is now underway. When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, was quoted in a Sept. 2 Yahoo! News story noting that three doses of an mRNA vaccine will be needed for full vaccination.
“I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses,” Fauci said at a COVID-19 White House briefing. He also noted that regulators would ultimately be the ones to make the determination. Fauci additionally pointed to evidence from Israel, where the efficacy of the vaccines — particularly against the delta variant — appeared to wane at about the eight-month mark.
Fauci also stated that the protection provided by the booster shot was “dramatic” and “durable,” with one Israeli study demonstrating that three weeks after the booster shot, a person’s risk of infection dropped by as much as 84%.
As NPR reported, Moderna is seeking booster shot authorization from the FDA to follow Pfizer’s preliminary steps. NPR noted that 344 volunteers who got an additional dose of the vaccine as part of a clinical study had antibodies boosted to “an even higher point than was seen after the initial shots, even though the booster was just half the original dose.” This trend was particularly notable in older adults. That study, like those with Israeli vaccine recipients, found that antibodies decrease over time.
The Biden Administration, in addition to considering the recent guidance, is dealing with the optics of two senior FDA officials, who oversee the agency’s reviews of coronavirus vaccines, announcing their retirement earlier this week. Marion Gruber, head of the Office of Vaccines Research and Review, will depart the agency at the end of October, with deputy Philip Krause leaving the following month.
The Washington Post story on the exits noted that “White House officials sidestepped questions about whether Gruber and Krause’s departures were linked to pressure on the agency.”
“As the president said last week, FDA is the gold standard,” White House coronavirus coordinator Jeff Zients said at a news briefing on Sept. 2. “We are all grateful for the tireless work of the senior team and the whole staff at FDA, especially during the pandemic.”