The booster plan has caused an uproar among the FDA and public health experts, who fear that publicly naming a date before enough data was available would put pressure on the agency to approve booster vaccines even if they did not care for the extra doses held justified. Two leading FDA vaccine regulators resigned last week, a move a senior official said was rooted in frustration with handling the booster launch.
The decision to delay rollout comes in part because Moderna does not have full results of its booster shot clinical trial and the FDA’s window of opportunity to review the data before September 20 is rapidly narrowing. Moderna, which began submitting booster data to the FDA on an ongoing basis this week, announced Friday that it had completed its application.
Officials still believe Pfizer, which completed its booster application with the FDA on Aug. 27, will be ready by the end of September target.
“It always depended on certain things going together, and it turned out that one thing didn’t go together,” said one of the interviewees.
the The New York Times reported first the potential booster delay.
It is also not clear when Johnson & Johnson will file an application to offer a second booster dose of its single vaccine. However, Biden government officials said there was more wiggle room for J&J boosters as the company’s vaccine wasn’t available in the US until months after the Pfizer and Moderna options.
Senior health officials are also waiting for a bunch of data from CDC that they expect to show breakthrough infections are more common than previously reported, especially as the Delta variant became dominant and states have struggled to track the spread of the variants.