Science trumps politics in COVID-19 vaccine EUA approval guidance

By: Dr. Anthony Salandy

Date: 7th, October 2020

 

There were huge concerns in from scientist that the COVID-19 vaccine approval process was being politicized. Some argued that the push by the administration to have a vaccine approved before general elections on November 3^rd was overly ambitious and lead to undue influences of those overseeing the process. On October 6^th, the FDA released guidance on criteria for Emergency Use Authorization for COVID-19 vaccine candidates in Phase 3 clinical trials.

The main requirements among others is that to receive an emergency authorization based on the new guidance, potential vaccines will have to provide an “interim analysis” of data proving effectiveness from Phase 3 clinical trials — the final stage of the drug evaluation process.

In addition, data from Phase 3 studies must “include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the guidelines state.

This includes information on adverse events, cases of severe COVID-19 disease among study participants and cases of COVID-19 “occurring during the time frame when … the vaccine would be responsible for a protective effect.”

Given these new requirements, a vaccine will not be approved through the EUA process earlier than the elections on November 3^rd. This new guidance secures the integrity of the scientific process underlying vaccine development and approval.