Coronavirus vaccines need to have 50% efficacy in preventing infection: US FDA

United States Food and Drug Administration (FDA) on June 30 issued guidance for commercial vaccine manufacturers and or entities that are developing COVID-19 vaccine. US FDA said it expects manufacturers to show that vaccine is 50 percent effective in a placebo-controlled trial before it can be widely deployed for treatment of disease. FDA issued guidance to make clear to manufacturers and sponsors what data would be required to meet regulatory standards for COVID-19 vaccine deployment.  

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"We recognize urgent need to develop a safe and effective vaccine to prevent COVID-19 and continue to work collaboratively with industry, researchers, as well as federal, domestic, and international partners to accelerate se efforts. While FDA is committed to expediting this work, we will t cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards. This is particularly important, as we kw that some people are skeptical of vaccine development efforts,” said FDA Commissioner Stephen M. Hahn, M.D. 

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FDA guidance

FDA also encourd to include people from all backgrounds in clinical developments and late phase trials, specifically racial and ethnic mirities who are most affected by COVID-19. It furr stated to provide data to support use of vaccines during pregnancy and size of data should be large eugh to prove effectiveness of vaccine. 

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"Emergency Use Authorization (EUA) of an investigational vaccine – making clear that an assessment regarding any potential EUA for a COVID-19 vaccine would be made on a case-by-case basis considering target population, characteristics of product, and totality of relevant, available scientific evidence, including preclinical and human clinical study data on product’s safety and effectiveness," guidance stated.

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