FDA guides on COVID-19 vaccine approval criteria

FDA guides on COVID-19 vaccine approval criteria
Jun. 30, 2020 12:01 PM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor 
The FDA has released guidance on its standards for approving a COVID-19 vaccine, including a 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 shown in a clinical study, an obvious criterion, nor 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 maker to conduct further safety monitoring post approval and will recommend following all vaccinated people for a year.

The FDA has drawn criticism over its quick approvals allowing the emergency use of diagnostic tests and certain drugs during the pandemic. After a number of the tests were found to be poor performers, it tightened its review process and rescinded EUA on some assays. It OK'd the emergency use of malaria drugs chloroquine and hydroxychloroquine then backtracked after neither proved effective in treating the respiratory infection.