Acting FDA Commissioner Janet Woodcock sent a memo Tuesday evening to vaccine regulators, reiterating her support as frustration over the process spreads within their ranks.
By SARAH OWERMOHLE
The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.
FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters’ benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team’s top-down booster plan and former President Donald Trump’s attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.
On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency’s lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.https://0308e7d0c6be3aa2509996be37cbbf8f.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html
POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration’s disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.
“We understand the importance of additional vaccine doses for control of this pandemic and will move as rapidly as possible to evaluate all submissions. Responding to this pandemic requires an all of government approach,” an FDA spokesperson told POLITICO. “FDA has and will continue to make regulatory decisions. And the [Centers for Disease Control and Prevention’s vaccine advisory committee] will continue to make clinical recommendations.”
Acting FDA Commissioner Janet Woodcock sent a memo Tuesday evening to vaccine regulators, reiterating her support as frustration over the process spreads within their ranks. “The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges,” Woodcock wrote.
President Joe Biden’s Covid-19 czar Jeff Zients backed up FDA as the regulatory “gold standard” in a Tuesday press briefing shortly after the departure news. “[The booster] decision was made by and announced by the nation’s leading public health officials… and as our medical experts laid out having reviewed all the available data, it is in their clinical judgment that it’s time to prepare Americans for a booster shot,” he said. “We announced our approach to stay ahead of the virus and to be transparent on latest data.”