The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals.
The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to hasten its review process.
In guidance released today, the agency said that data from vaccine candidates’ Phase 3 clinical trials should include a median follow-up of at least two months after study participants have received the full vaccination regimen. The timeframe will give the agency adequate information to assess a vaccine’s benefit-risk profile, including adverse events, cases of severe COVID-19 disease among study subjects, and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect, the guidance says.
FDA commissioner Stephen Hahn has repeatedly said that a vaccine will not be rushed, an assertion he repeated at a major medtech conference yesterday.
You can find out more about the top COVID-19 candidates here.