The Biden administration declared last month that it was planning to begin offering third-shot boosters for fully vaccinated Americans on Sept. 20. The announcement came a week after the FDA authorized third shots for folks who are immunocompromised.
But — as has become habit for federal government experts — the agencies charged with handling the pandemic and its various treatments are muddying the waters and causing further confusion.
Instead of backing President Joe Biden's plan to offer boosters to everyone later this month, the Food and Drug Administration and the Centers for Disease Control and Prevention told the White House to back off on its plan so regulators can collect and review more data, the New York Times reported Friday.
The FDA and CDC rained on the administration's booster parade just hours after White House chief medical adviser Dr. Anthony Fauci told the world Thursday that people will likely need a third dose in order to be considered fully vaccinated and get to enjoy freedom's privileges. And just a week ago, Biden and Fauci were discussing bumping the timeline for boosters up from eight months to five months.
According to the Times, acting FDA Commissioner Janet Woodcock and CDC Director Dr. Rochelle Walensky — both of whom, the Times pointed out, helped craft the Biden booster plan and publicly endorsed it — warned the White House off the booster push as their agencies needed more time to determine whether to recommend boosters for people who have received the Pfizer vaccine — "and possibly just some of them to start."
Health experts said that Woodcock's and Walensky's previous support for the Biden plan "increased pressure on scientists weighing the evidence for boosters within their respective agencies to go along with the administration's strategy."
The likely consternation created by the agency chiefs' push for the Biden booster idea coupled with media and political pressure to approve boosters would appear to explain Politico's report Tuesday that two top vaccine regulators at the FDA quit this week over growing turmoil and disagreement within the agency as political pressure to OK booster shots continued to mount.
White House spokesman Chris Meagher claimed to the Times, "We always said we would follow the science, and this is all part of a process that is now underway."
And of course, sources allegedly told the Times that Woodcock privately "argued that it was risky to set a firm date for a booster rollout before regulators had a chance to thoroughly review the data, some of which had yet to be submitted by the vaccine manufacturers, and decide whether shots were safe and necessary."
Agencies seek more time
So, what are the agencies' concerns? According to the Times:
Among the reasons for delaying is that regulators need more time to decide the proper dosage for a possible third Moderna shot. The company's application asking the F.D.A. to authorize a booster shot contains insufficient data, one federal official familiar with the process said. Other data expected from Johnson & Johnson has not been delivered.
Nor has the raw data that the F.D.A. has been seeking from Israel, which is already giving boosters to everyone 12 and older. Israeli officials say their data shows that the potency of Pfizer's vaccine wanes over time against severe disease and hospitalization, but that a third shot bolsters protection significantly. The F.D.A. wants to see the underlying data, to make sure it backs up summaries that the Israeli government has provided.
At least one member of the FDA's advisory panel charged with examining the booster recommendation, Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told the Times that boosters are currently unwarranted.
"There is no compelling reason to get a third dose" yet, Offit said to the paper.
He further criticized the White House for seeming to expect that the FDA and CDC would "rubber-stamp its booster timeline," the Times said. And he blamed the administration's actions for the resignation of the two top FDA vaccine regulators.
"Bypassing and marginalizing those agencies led veterans who you need in this pandemic to leave the F.D.A.," Offit said.