Moderna Spikes After FDA’s About-Face on mRNA Flu Vaccine

That was an unexpected and much-needed shot in the arm for Moderna.

On Wednesday, the US Food and Drug Administration announced it would begin reviewing the biotech firm’s new mRNA-based flu vaccine — just a week after the agency initially rejected Moderna’s application, citing flaws in the company’s research design. The reversal is not just a major win for Moderna, but the entire vaccine-making industry, which has struggled in an era of a, shall we say, far more skeptical FDA. 

Political Side Effects

If you recall, mRNA vaccines were seen just a few years ago as a breakthrough, allowing pharma firms to revise and update vaccines to respond to new viral threats far more quickly than old-school dead-virus-based jabs. Better yet, promising signs reveal the technology could have applications for warding off chronic diseases and even cancers. 

Now, the miracle product of Trump 1.0’s Covid moonshot has turned into a headache for pharma firms in the Trump 2.0 era. While the science and medical communities still see the new vaccine type as largely safe, the FDA, under Secretary of Health and Human Services Robert F. Kennedy Jr., is warier. The twist of fate has turned the entire vaccine-making industry upside-down:

• The number of distributed flu vaccine doses has fallen to a roughly 10-year low this season, according to the CDC, with some researchers pointing to medical misinformation. Major flu shot maker CSL is undergoing major cost-cutting amid declining demand, while Moderna has canceled projects to develop mRNA vaccines for ailments including chicken pox, shingles and herpes. 
• Investors, too, have taken note of the new landscape. Last year, venture capital firms invested just $174 million in biotech firms using mRNA technology to develop vaccines, down from $510 million in 2023, according to GlobalData.

“We are more wary,” biotech investor Peter Kolchinsky recently told The New York Times. “It’s clear that some vaccines are going to be harder to get through than others, so we have to invest more cautiously, if at all.”

Bank Shot: The impact for Moderna has been acute. The US government last year canceled some $700 million in contracts with the company to develop a bird flu vaccine; its share price is still down some 90% from its 2021 peak. The FDA reversed course on the company’s flu vaccine after Moderna said it would split the preventative by age bracket, seeking an accelerated approval timeline for patients over 64 and a standard review for those between 50 and 64, while agreeing to conduct an additional study for patients under 50. Shares of the company popped more than 6% on the good news on Wednesday.