(p. A19) In December 2020, the F.D.A. approved the distribution of mRNA coronavirus vaccines made by Pfizer and Moderna under the agency’s emergency use authorization provision, which permits an accelerated approval process for medications and treatments during a public health emergency.
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In theory, full approval should be imminent, since Pfizer applied for full approval in early May, and Moderna asked for full approval on June 1. This process is often long, requiring the agency to inspect manufacturing plants and review considerable amounts of documentation for vaccine production. But in this case, because of the urgency of the pandemic, the vaccine makers began to submit this material, called a biologics licensing application, in late 2020, and they’ve continued to submit more information. The F.D.A. has already reviewed some of the submissions and has provided feedback to the manufacturers. The emergency authorizations were granted more than six months ago. That’s more than ample time for the agency to conduct plant inspections and review the applications.
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Fortunately, two doses of the mRNA vaccines appear to provide nearly full protection from Covid-related hospitalization and death, and the shots substantially reduce infections.
The lives and health of millions of Americans rest on the F.D.A.’s decision to fully license these vaccines.
For the full commentary see:
Eric J. Topol. “Vaccines Need Full Approval.” The New York Times (Monday, July 5, 2021): A19.
(Note: ellipses added.)
(Note: the online version of the commentary has the date June 1, 2021, and has the title “It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines.”)