Baker frustrated by FDA’s pace on vaccine approvals

Boston Statehouse

FILE – In this March 29, 2021 file photo, a worker readies syringes with the Moderna COVID-19 vaccine in Metairie, La. Moderna plans to expand the size of its study in younger children to better detect rare side effects. The company said Monday, July 26, 2021 it is in talks with the Food and Drug Administration to enroll more patients in its study of the vaccine in children under 12 years old and younger. (AP Photo/Gerald Herbert, File)

BOSTON (SHNS) – The U.S. Food and Drug Administration is shifting employees around as it prioritizes the work necessary to determine whether to grant full approval to Pfizer’s COVID-19 vaccine, a spokesperson said on Friday, the same day that Gov. Charlie Baker criticized the pace of that process.

All three available COVID-19 vaccines were granted emergency use authorization but have not been approved by the FDA. Pfizer’s application for full approval has been pending since early May and Baker blasted the feds on Friday, saying the agency’s seal of approval could help convince more people to get vaccinated.

“Where’s the urgency at the federal level on this one? Where is it? I mean, I hear from people all the time who say to me, ‘I’d really like to see that thing get final approval.’ And I don’t blame them, I would too. I think it would make a really big difference,” the governor said. “And I would love to see the FDA finish their process, put the urgency into it that we all believe it deserves, recognize and understand that 400 million shots later and a ton of evidence that it makes a positive difference in the lives of those who’ve chosen to get vaccinated, that it would help and there’s plenty of data there to support it.”

In a statement issued Friday, an FDA spokesperson said the agency recognizes “that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated.” The spokesperson said the FDA is “identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” according to Yahoo News.

It is unclear how long the FDA’s review could take now that it has prioritized it, but President Joe Biden said last month that he expects a final approval at some point this fall. “But the expectation — they’re not promising me any specific date — but my expectation, talking to the group of scientists we put together … is that sometime maybe in the beginning of the school year — at the end of August, beginning of September, October — they’ll get a final approval,” the president said July 21.

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