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FDA Maps Expectations for COVID Vaccine Proposals

July 9, 2020

Via: PharmTech

With more than 100 vaccine research programs looking to address the pandemic, FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives. The agency recently issued a lengthy guidance outlining recommendations for documenting vaccine quality, safety, and efficacy in order for a product to move forward.

A main point of discussion is the provision that a vaccine should be at least be 50% more effective than placebo in preventing the disease, a standard that some criticized as much too low to tackle COVID-19 effectively.

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