Opinion | The F.D.A. on the Vaccine Reviews: ‘We Want to Assure the Public’

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To the Editor:

Re “Vaccines Need Full Approval,” by Dr. Eric J. Topol (Opinion guest essay, July 5):

We want to assure the public that the review of applications for full approval of Covid-19 vaccines is one of the highest priorities at the Food and Drug Administration. However, an extensive additional amount of manufacturing and clinical information has been collected since the emergency use authorizations and must be reviewed and evaluated by the agency as part of any applications submitted.

Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.

The F.D.A. is notable among the world’s regulatory agencies for its thorough scientific evaluation of submitted applications, which includes review and verification of data at the level of individual subjects enrolled in clinical trials. Our ability to fully approve the vaccines therefore depends on the submission of complete applications by the companies.

This approach helps to ensure that the F.D.A. has all the available data from clinical studies and provides the public with trust and confidence in the quality, safety and effectiveness of any vaccine that the agency approves.

As Dr. Topol correctly notes, all three Covid-19 vaccines currently authorized for emergency use in the United States have been thoroughly evaluated and have met, and continue to meet, the F.D.A.’s rigorous standards. If we truly want our lives to return to normal, the fastest way to do so is simple — get vaccinated right now.

Peter Marks
Silver Spring, Md.
The writer is director of the F.D.A.’s Center for Biologics Evaluation and Research.

To the Editor:

I couldn’t agree more with Eric J. Topol that the Food and Drug Administration needs to accelerate full approval of the Pfizer and Moderna vaccines. I have two granddaughters in their 20s who have adamantly refused to be vaccinated until full approval is given. I am sure they are not alone.

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