FDA releases COVID-19 vaccine guidelines

Over the past months as many pharmaceutical companies move towards US Food and Drugs Administration (FDA) license applications for their COVID-19 vaccines, the agency has been developing a set of recommendations for vaccine developers, which it has now released.

The main focus of these guidelines centre around the call for two months of data monitoring after participants received their final doses of vaccine. Despite numerous claims from the White House that a vaccine could be ready before the upcoming election on November 3rd, the latest recommendation means that is no longer a possibility.

The current set of guidelines had been submitted to the White House for publication more than two weeks ago; however, political concerns raised by Chief of Staff Mark Meadows meant the process had stalled. Instead, the guidelines have been released by the FDA as part of the briefing materials for its October 22nd meeting of independent experts, in an appendix summarising advice the agency has given to individual vaccine developers. The document states that even for emergency authorisations, the agency recommends submission of Phase III clinical trial data with “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”.

Moderna, a front-runner in the COVID-19 vaccine race, has agreed to abide by these guidelines and will not be submitting data to the FDA until late November at the earliest. Pfizer, another front-runner, is expecting initial efficacy results from its Phase III clinical trial in late October. A spokesperson for Pfizer has said that only two considerations – safety and efficacy – are guiding their work.

For further details, please read the complete FDA Briefing Document for Vaccines and Related Biological Products Advisory Committee Meeting – Development, authorisation and licensure of vaccines to prevent COVID-19. Further COVID-19 related information can also be found on FDA’s Emergency Preparedness and Response website.

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Published on 7. October 2020 in Interesting Reads, News