Why it may be a 'grave mistake' for FDA to wait much longer for full COVID-19 vaccine approval

·2 min read
Pfizer-BioNTech vaccine.
Pfizer-BioNTech vaccine. FREDERIC J. BROWN/AFP via Getty Images

Zeynep Tufecki, a sociologist who has written extensively on COVID-19 throughout the pandemic, is a proponent of broadening vaccine mandates in the United States, citing precedent in the health-care sector, the military, and schools.

Kentucky, she notes in a piece published Saturday in The New York Times, requires anyone working in a long-term care facility to be vaccinated against the flu and pneumococcal disease unless they have a medical or religious exemption (Brown University's Dr. Ashish Jha, another prominent voice during the pandemic, also pointed to flu vaccine mandates in nursing homes as a reason to implement them for the coronavirus). But Tufecki acknowledged that the fact that the Food and Drug Administration has still not granted full authorization for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines is an obstacle to imposing such requirements.

Both Pfizer and Moderna, which were granted emergency use late last year, have submitted their applications for full approval, and the former is apparently set to receive the green light no later than January 2022. Tufecki, for one, hopes the stamp comes much more quickly than that, however. "It would be a grave mistake for the agency to take another six months," she writes for the Times, explaining that the extra waiting time "has allowed some anti-vaxxers to claim the vaccines are experimental."

Additionally, she argues the holdup "helps feed a misunderstanding" about adverse side effects. The consensus among medical experts is that allergic reactions would occur shortly after inoculation, while other immune reactions could theoretically take longer, but would likely still occur "within the first few weeks and months after vaccination." Waiting, therefore, may suggest to some that the risk of those issues occurring down the line is higher than it is. At this point, Tufecki believes regulators have the six months of data they need, and should move quickly toward approval with the goal of increasing the U.S. vaccination rate again. Read Tufecki's full piece at The New York Times.

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