Top White House officials have reportedly raised objections to the FDA’s proposed standards for deciding whether a COVID-19 vaccine should be given widely — and don’t appear likely to sign off on them.
The Wall Street Journal, citing unnamed sources, reported White House officials expressed a number of concerns about the Food and Drug Administration draft guidelines, including a proposal to require researchers to monitor study subjects for side effects for two months after getting a shot.
The disagreement comes just ahead of late-stage trials data coming in — maybe as soon as a few weeks.
The FDA wanted the administration’s blessing to reassure Americans that any vaccines they might be offered would meet high standards, the Journal reported. And refusal could reignite concerns the Trump administration might interfere in science-based decision making at the FDA.
Among the White House officials raising concerns were chief of staff Mark Meadows and some high-ranking aides in the Office of Management and Budget, the Journal reported.
The sources told the Journal, however, even without the administration’s signoff, the FDA plans to follow its guidelines. The agency recently sent a letter to major vaccine manufacturers laying out the standards and saying vaccines must meet them in trials to secure authorization, the Journal reported.
The FDA wants to monitor study subjects for side effects for a median of two months following injection because safety issues typically emerge within about six weeks, the Journal reported.
If a vaccine met the standards, the FDA would clear the shot for use during the pandemic through emergency-use authorization, the Journal reported.