US FDA Needs To Harmonize Postmarket Safety Plans For COVID Vaccines, CDC Advisors Urge

The common ‘test-negative’ case-control design may have difficulty evaluating COVID vaccines’ real-world performance because of the limited diagnostic capabilities during the pandemic. In a JAMA editorial, Three members of CDC’s Advisory Committee on Immunization Practices push for US FDA guidance to harmonize safety endpoints and protocols to improve the monitoring of COVID-19 vaccines in both post-market trials and pharmacovigilance systems.