FDA releases guidance on COVID-19 vaccine approval: 4 things to know

The FDA recently delivered guidance for vaccine developers on how effective a COVID-19 vaccine will have to be to win full regulatory approval.

FDA Commissioner Stephen Hahn, MD, appeared before the Senate Health, Education, Labor and Pensions Committee June 30 to explain the agency's vaccine approval requirements. Here are four things to know about what he said:

  • To receive full approval, a COVID-19 vaccine will have to prevent the disease or lessen its severity in at least 50 percent of people who receive it.

  • Vaccine developers will need to closely monitor their vaccine's effectiveness and safety after winning approval.

  • The FDA expects vaccine developers to involve trial participants who are diverse in race and age.

  • The agency still considers emergency use authorizations, and any decisions made regarding temporary approvals will be made on a case-by-case basis.

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