The FDA recently released stricter guidelines for the development of a coronavirus vaccine, calling on developers to provide comprehensive safety data from clinical trials before the agency grants an emergency authorization. The new recommendations were submitted for White House approval on September 21 and do not carry the force of law.
In June 2020, the agency issued initial guidelines on an acceptable vaccine candidate for developers looking to submit applications for emergency use or full license. The agency hopes the updated guidelines will assure vaccine developers they are being held to a common standard and boost public confidence; opinion polls have shown declining confidence among Americans regarding a coronavirus vaccine that seems to have been rushed through the approval process.
Vaccine developers are advised to follow study participants for a median of 2 months after the final dose and document five cases of severe infection in volunteers who received placebo instead of the vaccine.
The White House opposed the new recommendations and stalled the approval initially, arguing that they add unnecessary burdens on the companies developing the vaccines.
PhRMA, the pharmaceutical industry’s largest trade group, spoke out in support of the guidelines. “We have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines,” it said in a statement. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”