The FDA has released guidance on its standards for approving a COVID-19 vaccine, including the requirement that it must demonstrate that it is at least 50% more effective than placebo (a low bar compared to vaccines for other infectious diseases) .
The agency says it will not approve any candidate unless safety and efficacy have been clearly demonstrated in a clinical study, an obvious criterion, or if the vaccine simply leads to antibodies in the bloodstream (due to the uncertainty of knowing what level of antibodies confer immunity against the SARS-Cov-2 virus).
It will also require a vaccine manufacturer to do more safety monitoring after approval, and will recommend following all vaccinated people for one year.
The FDA has come under fire for its speedy approvals that allow emergency use of diagnostic tests and certain medications during the pandemic. After a series of tests were found to be underperforming, it tightened its review process and nullified the EUA in some trials. ACCEPTED the emergency use of antimalarial drugs, chloroquine and hydroxychloroquine, and then regressed after neither proved effective in treating respiratory infection.
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