FDA issues guidance on COVID-19 vaccine development

The Food and Drug Administration today issued guidance on development of vaccines to prevent COVID-19.

According to the FDA, the guidance reflects advice it has been offering the past few months to companies, researchers and others, and contains the FDA’s current recommendations on data needed to manufacture, develop and receive final approval.

While it is expediting the work, the FDA still has a responsibility to make sure its decisions are based on science and available data, according to FDA officials. The FDA will only approve or make available a COVID-19 vaccine if it determines that it meets high standards that are expected of the FDA, the official stated.

The guidance, “Development and Licensure of Vaccines to Prevent COVID-19,” is at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19.

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