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.
You may also be interested in...
Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.
Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.