Moderna Withdraws Application for Combination COVID and Flu Vaccine

Moderna, Inc. withdrew its application for United States licensure for its combination COVID-19/Influenza vaccine known as mRNA-1083. The company stated the decision came “in consultation with” the U.S. Food and Drug Administration (FDA).¹

The decision came just one day after the FDA announced the agency would require new clinical trials for approval of annual COVID boosters for healthy individuals under age 65. FDA Commissioner Marty Makary, MD, MPH and director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, MD, MPH wrote in The New England Journal of Medicine (NEJM) that the benefit of repeated annual COVID shots for was uncertain. The two also noted that the U.S. was one of few high-income nations recommending yearly COVID shots for healthy adults.¹

“We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose,” Dr. Prasad said.²

Moderna states that it plans to resubmit the application later this year after vaccine efficacy data from the ongoing Phase 3 trial of its experimental mRNA-based seasonal influenza vaccine, mRNA-1010, are available. That data is expected to be released this summer.^{1 3}

 The combination mRNA COVID/Influenza shot was submitted to FDA for licensure last year. Moderna said that the combination vaccine performed well in a phase 3 clinical trial in 2024 and elicited immune responses that were at least as good as those of the standard influenza vaccine or COVID shots.^{1 3}

Lagging Vaccine Uptake and Stock Decline Fuel Strategic Shift

 The Guardian reports that Moderna has been banking on revenue from newer mRNA-based biologicals, such as the combination COVID/Influenza shot, to make up for falling sales of the company’s mRNA COVID vaccine (Spikevax) and lower-than-expected uptake of its respiratory syncytial virus (RSV) vaccine, which sent its shares down nearly 60 percent last year.”³

Polls Show Growing Number of Americans Declining Vaccines

Poll results from the Cleveland Clinic found that 35 percent of Americans are not concerned about influenza, COVID, and RSV (respiratory syncytial virus) cases, and do not feel they need to take vaccines to prevent those infections.⁴

Latest findings looking at influenza vaccine efficacy suggest that the vaccine’s protection is very  short-lived or may even increase the risk of influenza infection over time.⁴ At present, influenza vaccines do not utilize mRNA technology, but companies such as Moderna and Pfizer are planning to develop mRNA influenza biologicals.⁵

Pharmaceutical Companies Want mRNA Technology to Replace Traditional Vaccine Production

The development process for selection of influenza virus strains for annual flu shots involves monitoring influenza viruses that circulate before the flu season begins. The World Health Organization (WHO) and the FDA then make recommendations for selection of type A and type B influenza virus strains to include in flu shots for the upcoming flu season based upon their best guess estimate of which strains will be most prevalent. From there, a candidate influenza virus strain is injected into eggs where it replicates. Two other types of influenza vaccines are (1) cell-based, which uses cultured animal (dog kidney) cells instead of eggs for production, and (2) recombinant, which contains synthetic versions of the influenza virus and uses insect cell baculovirus production technology.^{6 7}

Describing an mRNA-based influenza vaccine waiting to be unveiled in the near future, Verna Welch, Senior Director at Pfizer says that “because mRNA can tell our bodies what types of proteins to make, the sky may be the limit when it comes to its potential to protect or even improve health.” She believes that mRNA could have application in cancer treatments, rare disease therapies, and gene editing.⁸

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