FDA to Require Proof Virus Vaccine Is Effective Before Approving Its Use - (The Wall Street Journal via NewsPoints Desk)

  • The FDA issued guidelines Tuesday outlining conditions for approving a COVID-19 vaccine, including that any vaccine be at least 50% more effective than placebo in preventing the disease, a benchmark used routinely in influenza vaccines, reported The Wall Street Journal.

  • The agency said it would not approve, or give emergency-use authorization, to any coronavirus vaccine unless the maker had clearly demonstrated proof of its safety and effectiveness in a clinical study.

  • In its new guidance, the FDA noted it would not clear a vaccine simply if it leads to antibodies in patients' bloodstreams as it remains unknown what level of antibodies confers protection.

  • The agency also said it would require a vaccine maker to conduct further safety monitoring after any approval, and recommended that vaccine recipients be followed for a year after treatment.

  • "We have not lost sight of the need to protect our regulatory independence" during the COVID-19 pandemic, said FDA Commissioner Stephen Hahn, adding he is optimistic that therapeutics like convalescent plasma and monoclonal antibodies would play a significant role this fall in helping infected patients.

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