FDA commits to data transparency in COVID EUAs
As the time draws near for the leaders in the global race for a vaccine against COVID-19 to submit emergency use authorization (EUA) authorizations to the US Food and Drug Administration (FDA), the agency has proclaimed a new commitment to transparency.With a stated goal of disclosing information from COVID-19-related EUA review documents “as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals,” FDA also reserved to itself the ability to redact trade secrets or other information that would be exempt from disclosure under the Freedom of Information Act (FOIA) or protected from disclosure by other legislation.
In a 17 November statement announcing the agency’s ongoing commitment to transparency for COVID-19-related EUAs, FDA commissioner Stephen Hahn, MD, said, “I am announcing today that our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response.
“We have already posted some scientific review documents, for instance for an EUA revocation as well as an EUA authorization, and we are committing to continuing to post these documents moving forward,” said Hahn. He clarified that information from review documents will be made available after the agency’s review process has been completed.
Throughout the pandemic, FDA has been posting the letters of authorization it issues to those whose products receive EUAs. These letters specify the conditions under which the product is authorized.
Hahn had previously stated, and reiterated today during a presentation for members of the Regulatory Affairs Professionals Society (RAPS), that all vaccine EUA determinations will be made after an open meeting of the Center for Biologics Evaluation and Research’s Vaccines and Related Blood Products Advisory Committee (VRBPAC) is held so the independent committee can review the authorization application materials and weigh in.
At a 22 October meeting, VRBPAC met to weigh general considerations for approval of a COVID-19 vaccine. This meeting was made available on YouTube, in addition to the webcast arrangements the FDA usually provides for advisory committee meetings.
In October, the European Medicines Agency (EMA) outlined additional transparency measures it was taking during the pandemic, including posting full deidentified clinical trial data for both COVID therapeutics and vaccines.
EMA is making these data available after marketing authorization; the agency currently has rolling reviews underway for three of the leading vaccine candidates, with no announced dates for marketing authorization decisions. (RELATED: EMA outlines regulatory transparency measures amid COVID pandemic, Regulatory Focus 30 October 2020; EMA kicks off rolling review of AstraZeneca COVID vaccine candidate, Regulatory Focus 01 October 2020)
Hahn statement