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COVID-19 Vaccine Should Demonstrate At Least 50% Effectiveness, US FDA Says

 
• By Brenda Sandburg

Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.

Medical doctor or laborant holding tube with covid vaccine and microscope. Coronavirus 2019-nCoV COVID concept.
FDA issues guidance for development of COVID-19 vaccines • Source: Shutterstock

The US Food and Drug Administration has set a bar for sponsors to meet in developing COVID-19 vaccines: an efficacy rate of at least 50%. The recommendation is intended to ensure resources are not wasted on a vaccine of limited value and to garner public confidence so people get vaccinated, thereby increasing the likelihood of achieving herd immunity.

The agency set the effectiveness bar in its

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