In its analysis of data Moderna submitted to support the authorization of its booster shot, the FDA noted that the data on waning immunity against infection and symptomatic disease is mixed. The drugmaker submitted data showing a third dose could boost antibody levels, but it didn’t study how that affects how many people get sick. FDA noted that the data showing robust protection against hospitalization and death remains strong.
“There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” the FDA also noted.
These thorny questions have led to unprecedented public debate, even within the FDA’s ranks, over the role boosters should play in the White House’s pandemic response and whether millions of stockpiled shots should be shipped abroad.
Despite some internal dissent, the FDA’s leaders did not derail the White House’s plans to roll out booster shots during the week of Sept. 20, although the group of people allowed to get a third Pfizer dose was narrower than Biden preferred. Some experts argue Biden politicized a scientific debate by announcing his preferred timeline before the advisers and regulators reached decisions.
“There was a lot of confusion about the goals,” said Jesse Goodman, a Georgetown University biotech expert and former FDA chief scientist, who was not a participant on the call. “But this is what happens when the question and the data aren’t laid out first, but the decision is laid out first. People choose sides and get fixed beliefs.”
Meanwhile, supporters of the booster strategy are getting impatient with calls for more thorough data and calls to donate stockpiled vaccines abroad, saying the White House should be as proactive as possible.
“Every country’s leader’s primary responsibility is to protect the people of that nation,” said William Haseltine, a former professor at Harvard Medical School, HIV expert and biotech investor.
Haseltine said Biden is being unfairly “boxed in” by independent advisers to FDA and CDC.
“We’re betting against the unknown. Every time we’ve bet against the unknown in this pandemic, we’ve lost,” he said.