Moderna Cancels Vaccine Development, Possibly for STIs

On February 11, Moderna, the U.S. pharmaceutical company, was informed in a “Refusal-to-File” letter from the U.S. Food and Drug Administration (FDA) that the agency would deny formal review and acceptance of Moderna’s filing for an mRNA-based influenza vaccine.¹ Moderna became known worldwide for its Covid-19 vaccine Spikevax, which also relies on the so-called messenger RNA (mRNA) technology and, together with BioNTech’s Comirnaty from Mainz, not only ranked among the first Covid vaccines but among the very first vaccines ever to use mRNA.

Before Phase 3 trials even began, Moderna says it had talks with the FDA in which the agency ostensibly approved the trial design. Yet despite the close collaboration and well-documented assurances from the agency, the FDA gave the company the cold shoulder. The FDA ostensibly has a whole toolbox of constructive levers in its review process to understand and ensure the safety and benefit of a vaccine. But here, choosing the harshest path by flatly rejecting a review process without prior notice suggests that this isn’t a matter of rational decision-making, but a stubborn, ideologically charged political stance.

Erratic Approval Policy

Also fueling this suspicion is the FDA’s justification: Moderna allegedly did not adhere to the clinical trial requirements for submission and used an unsuitable (yet FDA-approved) standard influenza vaccine as a comparator.² FDA guidelines, however, call for the comparator to be a high-dose influenza vaccine. Notably, Moderna’s submission included several studies, one of which used the mandated high-dose vaccine as the comparator.³ All previously published study results also show that the mRNA influenza vaccine demonstrates higher efficacy than traditional vaccines and maintains a favorable safety profile.

This decision could have symbolic implications beyond the current case. Such erratic approval policy risks slowing vaccine research across the board—especially in the realm of mRNA technology. If companies anticipate unpredictable, politically driven headwinds at any time, they will be reluctant to invest multi-million-dollar sums in research.

Vaccine Opponents Leading the Health Department

Under the leadership of Robert F. Kennedy Jr., the U.S. Department of Health and Human Services has already cut roughly $500 million in funding for the development of mRNA vaccines.⁴ The government has also pulled funds from Moderna for advancing an mRNA vaccine against bird flu.⁵ Kennedy has long been known as a vocal vaccine opponent with outspoken yet scientifically unfounded sentiments about vaccines. When the cuts were announced, he again criticized the mRNA technology, which often sits at the center of his concerns about modern vaccines.⁶ He contends that the risks outweigh the benefits, without providing scientifically robust evidence. To give his opposition political expression, he also reorganized the national vaccine advisory panel and urged children and pregnant women to skip Covid-19 vaccination altogether.⁷

The impact of this hostile stance toward mRNA vaccines has been evident for months, especially at Moderna. CEO Stéphane Bancel said at the end of January that, due to political headwinds and rising vaccine skepticism more broadly, all investments in research on vaccines for infectious diseases were being scaled back.⁸ Research programs to develop vaccines against herpes simplex and herpes zoster were already put on ice last year. This cut could soon extend to programs targeting other commonly transmitted pathogens such as HIV, Epstein-Barr virus (EBV), and cytomegalovirus (CMV), as well as against Borrelia, noroviruses, and respiratory syncytial virus (RSV).