Moderna today said it is developing a combination vaccine that will protect against both influenza and COVID-19. This innovative shot utilizes messenger RNA technology to generate antibodies, potentially offering a dual defense against seasonal flu and the ongoing pandemic virus. The study assessing the vaccine’s efficacy measured antibody levels in participants’ blood after 29 days, indicating a short-term response that suggests some initial disease protection.
The story isn’t over, because U.S. government regulators are asking for more information before giving the green light. The Food and Drug Administration (FDA) has expressed the need for more comprehensive information regarding the vaccine’s capacity to prevent illness. The FDA appears to be seeking a more robust evaluation of the vaccine’s effectiveness. Instead, they’re focusing on the degree to which the shot reduces a person’s chance of developing disease.
In response to these regulatory requirements, Moderna has moved its target date for the vaccine’s approval to 2026. That ask for more data, which was made last week, further underscores the FDA’s temperamental caution with respect to any new vaccine formulations.
Dr. Greg Poland, an expert in vaccine responses at the Mayo Clinic who was not involved in Moderna’s study, commented on the situation. He underscored the need for efficacy data in this scenario.
“I agree in this case with FDA that efficacy data are important to see.” – Dr. Greg Poland
Dr. Poland cast doubt on how much of a public appetite there will be for a combination shot. For that reason, he imagines dual vaccines will have a hard time getting widespread acceptance.
Moderna isn’t alone in these troubling developments — just last week, Novavax came under fire from the FDA for the same. The agency has asked Novavax to run a new clinical trial for its protein-based COVID-19 vaccine. This is a disappointment given that FDA had previously approved the vaccine’s full approval. Vaccination We have been talking a lot about vaccine effectiveness and regulators are now asking for more stringent data on vaccine effectiveness. This trend is incredibly timely as new COVID variants and seasonal flu continue to appear.
