The FDA’s Center for Biologics Evaluation and Research (CBER) has reversed course, deciding to review Moderna’s application for an mRNA flu vaccine after previously refusing. CIDRAP has the news.
Moderna proposed a “revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. Moderna is now seeking full FDA approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.” The FDA accepted its application for review.
The FDA initially refused to review the application because it said “Moderna’s phase 3 study was not ‘adequate and well-controlled.’” This contradicted the FDA’s earlier position, where they did not express “any concern with the safety or efficacy” of the vaccine candidate.
The FDA has “slashed $500 million in mRNA contracts as of last August. [HHS secretary] Kennedy has been a longtime opponent of mRNA vaccines, including the vaccines developed against COVID-19 during Operation Warp Speed under President Donald Trump’s first term.”
