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You Can Trust the FDA’s Vaccine Process

Thought Leader: Scott Gottlieb
September 22, 2020
Source: Link

By Scott Gottlieb and Mark McClellan (original source Wall Street Journal)

“If one or more Covid vaccines prove safe and effective in large clinical trials, the Food and Drug Administration should make them available, in a careful and limited way, to those at highest risk of contracting infection and suffering a bad outcome.

Last week we wrote on these pages how the FDA could allow a Covid vaccine to be used by specific groups of patients through an Emergency Use Authorization. This authority, created by Congress to allow the FDA to respond to a public-health emergency, lets the agency authorize the distribution of a product before a full approval.

There is concern that an EUA is a lower bar than the FDA’s rigorous standard for safety and effectiveness. Or that the EUA decision could be subject to political influence similar to some clumsy, recent intrusions into reports issued by the Centers for Disease Control and Prevention. We reject the claim that a vaccine EUA inherently falls short of FDA’s gold standard review, or that the process will be hijacked.

The process enables the FDA to grant a staged entry of a vaccine. The FDA has made clear that a vaccine must first demonstrate safety and effectiveness in a rigorous clinical trial with at least 30,000 people. It must show fewer and less severe infections, not merely an immune response as a proxy. It must also show no significant safety issues, which generally arise within the first month or two after vaccination.”

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