Moderna’s mRNA COVID vaccine is one of two mRNA vaccines currently available in the U.S. A recent phase 3 clinical trial published in the Journal of the American Medical Association showed promising results for Moderna’s combined COVID and flu shot. This new vaccine utilizes the same messenger RNA technology as Moderna’s approved COVID vaccine. The trial, funded by Moderna, involved over 8,000 adults aged 50 and older enrolled between October and November 2023.
In the trial, the new combination vaccine was compared to existing standalone vaccines for both COVID and the flu. Participants either received the existing shots or the new combination vaccine along with a placebo shot. The study aimed to assess the production of antibodies in blood samples against various strains of influenza and the XBB.1.5 COVID variant.
The results indicated that the combination vaccine generated higher antibody levels for COVID and most influenza strains compared to the existing shots. Dr. Buddy Creech from Vanderbilt University Medical Center noted that the antibody levels from the new vaccine were 20% to 40% higher. Dr. Jesse Goodman from Georgetown University expressed optimism that the combination shot could offer robust protection against both COVID and the flu.
While side effects like fever and chills were more common with the new vaccine, this is attributed to the body’s immune response to the vaccine. Experts believe that a combination shot could simplify the vaccination process for both COVID and the flu, especially considering they are typically administered in the fall. Moderna is expected to seek FDA approval based on this data, with a projected approval timeline of 2026. The FDA’s requirement for late-stage efficacy data against the flu may impact the approval process for the combination shot.
The delay in Novavax’s Covid vaccine has led to the need for an additional clinical trial and may result in updated requirements for Pfizer’s and Moderna’s Covid vaccines in the fall. A spokesperson for Moderna declined to provide a comment, while there was no immediate response from an HHS spokesperson to a request for comment. Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, highlighted that mRNA vaccines are a specific target for anti-vaccine activists, leading to the introduction of legislation in several states aiming to ban them. He expressed concerns about the rise of anti-vaccine sentiments in the United States and the specific focus on the mRNA vaccine platform by activists. Hotez emphasized the potential benefits of Moderna’s combination shot, which could streamline vaccination by requiring only one shot for two respiratory viruses and potentially extending to other pathogens like RSV. Meanwhile, Goodman from Georgetown University suggested that an mRNA-based shot targeting the flu could enhance the U.S.’s ability to respond swiftly to a potential influenza pandemic, as the current flu shots rely on a slower production process involving growing virus strains in eggs compared to mRNA vaccines.
