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

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

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"We recognize the 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 these efforts. While the FDA is committed to expediting this work, we will not 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 know that some people are skeptical of vaccine development efforts,” said FDA Commissioner Stephen M. Hahn, M.D. 

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FDA guidance

The FDA also encouraged to include people from all backgrounds in the clinical developments and late phase trials, specifically racial and ethnic minorities who are most affected by COVID-19. It further stated to provide data to support the use of vaccines during pregnancy and the size of data should be large enough to prove the effectiveness of the 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 the target population, the characteristics of the product, and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data on the product’s safety and effectiveness," the guidance stated.

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