Why it may be a “big mistake” for the FDA to wait much longer for full COVID-19 vaccine approval



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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 expanding vaccine mandates in the United States, citing precedents in the healthcare industry, the military and schools.

Kentucky, she notes in an article published on Saturday in The New York Times, requires that anyone working in a long-term care facility be vaccinated against influenza and pneumococcal disease, unless they have a medical or religious exemption (Dr. Ashish Jha of Brown University, a another important voice during the pandemic, also underline influenza vaccines warrants 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 a barrier to imposing such requirements.

Pfizer and Moderna, which secured emergency use late last year, have submitted their requests for full approval, and the former is reportedly expected to be given the green light no later than January 2022. Tufecki, for its hand, hope the stamp will come a lot faster than that, however. “It would be a big mistake for the agency to take another six months,” she wrote for the Times, explaining that the additional waiting time “allowed some anti-vaccines to claim that the vaccines are experimental.”

Additionally, she argues that the heist “helps fuel a misconception” about unwanted side effects. The consensus among medical experts is that allergic reactions would occur soon after inoculation, while other immune reactions could theoretically take longer, but would likely still occur “in the first few weeks and months. after vaccination “. Waiting, therefore, may suggest to some that the risk of these problems occurring later is greater than it is. At this point, Tufecki believes regulators have the six months of data they need and should move quickly to approval with the goal of increasing the vaccination rate in the United States again. Read Tufecki’s full article at The New York Times.

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