The U.S. Food and Drug Administration will convene an outside advisory committee on June 18 to review Moderna’s experimental seasonal influenza vaccine, the agency said in a federal register notice. The meeting will be conducted by the FDA’s Vaccines and Related Biological Products Advisory Committee, which provides independent advice to the agency on vaccine approvals.
Moderna’s mRNA-based flu candidate is currently under FDA review after regulators initially rejected the company’s original application. At the time of that rejection in February, the agency cited concerns about the standard-dose flu shot used in the study’s comparison group. Following discussions with Moderna, the FDA accepted an amended application. That acceptance came with an expectation voiced by Moderna that the company will perform an additional study in older adults once the vaccine is approved.
The agency has set a target date of August 5 for a decision on the application. If the FDA grants approval, Moderna’s vaccine would be the first seasonal flu shot authorized in the United States that uses messenger RNA technology - a platform distinct from conventional flu vaccine manufacturing.
Separately, the company reported results from a large late-stage international trial earlier this month showing that its mRNA flu vaccine performed better than conventional flu shots in a study population of more than 40,000 adults aged 50 and older. Those trial findings are among the data the advisory committee will consider as it advises the FDA on the application.
Political and public perceptions are also noted in the public record. Health Secretary Robert F. Kennedy Jr. is identified as a prominent critic of mRNA technology, which underlies Moderna’s shot as well as most COVID-19 vaccines.
The advisory committee meeting provides a formal opportunity for outside experts to scrutinize Moderna’s data, including the design of its clinical comparisons and the results from the large phase of testing in older adults. The committee’s recommendation will inform the FDA as it proceeds toward the August 5 decision date.
Context and next steps
The June 18 advisory meeting and the August 5 regulatory deadline are the next scheduled milestones in the FDA’s review process for Moderna’s seasonal mRNA flu vaccine. Should the agency approve the shot, Moderna has indicated it will conduct an additional older-adult study after authorization, consistent with the terms discussed between the company and regulators.