Biden’s Coronavirus Booster Plan Clashes With the FDA
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.
