In a significant turn of events, the Food and Drug Administration (FDA) has reversed its previous stance and will now proceed with reviewing Moderna’s groundbreaking flu vaccine for potential approval. This news was shared by Moderna on Wednesday.
Just last week, the FDA had initially dismissed Moderna’s application, citing concerns about the research methodology. However, following further discussions, the agency changed its mind, agreeing to move forward with the review process.
Moderna structured its application in two parts: seeking standard approval for individuals aged 50 to 64, and an expedited review for those 65 and above. The company also committed to conducting a supplementary study for the 65+ age group once the vaccine is on the market.
The FDA has set an August deadline for its decision. Should the vaccine receive authorization, it could be ready for older adults by the upcoming flu season later this year.
This vaccine utilizes messenger RNA (mRNA) technology, a method that has drawn repeated criticism from Health Secretary Robert F. Kennedy Jr., who claims it’s both unsafe and ineffective. Despite these criticisms, the mRNA approach — which essentially teaches the body to create a viral protein fragment to trigger an immune response — was highly successful in COVID-19 vaccines and is generally regarded as safe by leading public health experts and scientists.
Even though mRNA technology saw significant development during the first Trump administration, its application has been severely restricted over the past year, causing considerable disruption within the vaccine industry. Numerous research contracts and projects, totaling hundreds of millions of dollars, have been terminated. Furthermore, agencies overseen by Mr. Kennedy have drastically narrowed guidelines for COVID-19 vaccine administration to specific demographics.
The initial rejection letter for Moderna’s application was signed by Dr. Vinay Prasad, the FDA’s leading vaccine official, despite objections from the agency’s second-highest-ranking vaccine scientist. Dr. Prasad’s primary concern revolved around the control vaccine used for individuals over 65 in Moderna’s extensive 41,000-person study, deeming it not the optimal comparative choice.
Moderna poured hundreds of millions into this study, complemented by a substantial $750 million investment from Blackstone.
During a PhRMA (pharmaceutical industry’s trade group) event in Washington on Tuesday evening, FDA Commissioner Dr. Marty Makary briefly touched upon last week’s vaccine application rejection.
He remarked to the fireside chat moderator, ‘If we’re discussing last week’s events, it’s crucial to be aware of the precise trial results, which are publicly accessible.’
Regarding vaccine policy more generally, he defended the administration’s recent significant reduction in recommended childhood immunizations. He asserted that these changes were intended to foster greater public trust in federal health recommendations, stating, ‘I want to see more kids get vaccinated.’
During Moderna’s earnings call last Friday, CEO Stéphane Bancel expressed concerns to analysts that the FDA’s actions could hinder the advancement of new medical treatments. He emphasized that ‘the current unpredictable nature of the U.S. FDA regulatory environment poses significant obstacles for companies, patients, and the entire innovation sector.’
Meanwhile, other regulatory bodies in Europe, Canada, and Australia are also evaluating Moderna’s vaccine for their respective markets.