We need clarity on FDA vaccine approval

The FDA is undermining its credibility by not communicating more clearly regarding COVID-19 vaccines.

By

Opinion

August 5, 2021 - 8:28 AM

As calls for the Food and Drug Administration to fully approve COVID-19 vaccines grow louder, the agency itself has little to say. This is a mistake. The agency insists it is “working as quickly as possible” and has suggested that full approval may come for at least one vaccine by the end of summer. The public is left wondering: What’s taking so long?

This isn’t just a minor nuisance. It undermines trust in the vaccines and damages the FDA’s most valuable asset — its credibility.

The drug regulators have good reason to insist on thoroughly reviewing many months of clinical trial data before fully licensing any medicine. The emergency use authorizations for the vaccines now administered in the U.S. were based on just two months of follow-up data — enough to be confident that the vaccines are safe, effective, and fit for use in response to a pressing need, but relying on a faster analysis than the FDA requires for its full approval process. To fully approve the vaccines, the FDA looks at more data and satisfies itself on a range of other issues, including developing detailed guidance on use.

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