FDA to review Moderna’s mRNA-based flu vaccine

The Food and Drug Administration reversed course Wednesday and agreed to review for approval Moderna’s new flu vaccine based on mRNA technology.

The regulatory agency, which falls under the purview of Health and Human Services Secretary Robert F. Kennedy Jr., rejected Moderna’s application for approval of the vaccine last week, citing concerns about the study design in the drug’s clinical trials. 

Moderna said the FDA agreed to review the vaccine after it amended its application and met with regulators. The new application employs an age-based formula that seeks accelerated approval for adults age 65 and older, a group particularly vulnerable to the flu. It seeks regular approval for adults age 50 to 64, the company said Wednesday. 

The FDA’s rejection of Moderna’s initial application ignited concern across the drug manufacturing industry and the medical community, which have been forced to grapple with the Trump administration’s slashing of funding for vaccine research and development. 

Moderna’s flu vaccine hinges on mRNA technology, which Kennedy has repeatedly argued is unsafe and inefficient despite its success with vaccines during the coronavirus pandemic and broad acceptance from public health experts, scientists and medical professionals.

The FDA’s about-face came after further discussion with Moderna led to a revised regulatory approach and the amended application, a spokesperson for the agency said Wednesday. The FDA did not provide details on the discussions. If approved, the vaccine could be available in time for this year’s flu season.

The Trump administration last summer canceled almost $500 million in contracts for the development of mRNA vaccines to prevent viral threats and biological attacks. The federal Biomedical Advanced Research and Development Authority, which oversees the nation’s defenses against such threats, canceled 22 contracts with researchers and universities for the study of mRNA technology. The formula, developed under Trump’s first administration in response to the pandemic, is widely credited as safe and effective among experts. 

Under Kennedy, HHS has dramatically limited the scope of individuals who are eligible to receive the Covid-19 vaccine and has reshaped the childhood vaccine recommendation schedule.