FDA details next steps for Moderna COVID-19 vaccine

Chris Davies - Dec 1, 2020, 12:09pm CST
FDA details next steps for Moderna COVID-19 vaccine

The US FDA has set a date for its vaccine advisory committee to evaluate Moderna’s COVID-19 drug, which was submitted for emergency use authorization this week. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is responsible for giving scientific and public health advice on proposed drugs and treatments, like the coronavirus vaccine candidate, ahead of the Food and Drug Administration deciding whether or not to give them the green-light for public use.

Moderna announced earlier this week that it would be submitting its vaccine candidate, mRNA-1273, to the FDA for emergency use authorization (EUA). That’s the mechanism by which the regulator has been fast-tracking potential treatments, medical devices, and other drugs and items considered useful in dealing with the growing COVID-19 pandemic.

The vaccine candidate, however, is the first time it will weigh an EUA for a possible preventative for COVID-19. Unsurprisingly, it’s a hot-topic issue, particularly given contrary advice from different experts and politicians, and an absence of US-wide healthcare guidance and rules. Part of the FDA’s challenge, the agency has previously admitted, is convincing certain skeptical portions of the public that vaccines themselves are safe, particularly if their development was accelerated by the pressing needs of the pandemic.

“In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” Stephen M. Hahn, M.D., FDA Commissioner, said in a statement.

The VRBPAC usually consists of a Chairperson, along with scientific and public health experts, along with consumer, industry, and occasionally patient representatives. It can also add further experts should the topic demand that. While its advice is considered a key part of the FDA’s decision to grant an EUA request, the final decision is the FDA’s alone.

“The FDA understands there is tremendous public interest regarding vaccines for COVID-19,” Hahn continued. “We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.”

The VRBPAC hearing will take place on December 17, with the FDA streaming it online. Documentation should be made available at least two days ahead of time, and will be opening a public docket for comments as well. Even if the committee decides in favor of Moderna’s vaccine, however, that doesn’t mean it can go ahead with distribution.

Instead, the FDA will need to rule on it separately. The more than two weeks between Moderna’s submission and the hearing will be used, the FDA says, “to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.”

Moderna has said it expects to have approximately 20 million doses of mRNA-1273 ready for use in the US by the end of 2020. First supplies are likely to be reserved for the most at-risk groups, including primary healthcare responders and essential workers.


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