Reviewers with the Food and Drug Administration (FDA) announced that Moderna’s flu vaccine made with mRNA technology is “effective.”
While reviewers noted that there is “clinical benefit” to the inoculation, the review document explains that “efficacy in immunocompromised individuals and very frail older adults has not been established.” The lack of data for this population was described as “significant” as the group faces the “highest absolute risk of severe influenza-related complications and may respond differently to mRNA-based vaccine platforms.”
The reviewers noted that the vaccine did run the risk of adverse reactions. “Solicited adverse reactions (ARs) within 7 days postvaccination were more frequent in mRNA-1010 recipients than in comparator recipients in both pivotal studies but were predominantly mild to moderate in severity with a median duration of approximately 2 days,” the document states. There were no cases of myocarditis or pericarditis within 42 days of postvaccination.
In February, the FDA agreed to review an application from Moderna concerning its mRNA influenza vaccine after previously denying the company’s effort. Moderna held a Type A meeting with the FDA and proposed a “revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010,” a press release explained. Under the company’s revised proposal, it now seeks full approval for adults ages 50-64 and an accelerated approval for those aged 65 and older.
Initially, the FDA’s letter of refusal, signed by the agency’s Center for Biologics Evaluation and Research (CBER) Director Vinayak Prasad, “identified the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna’s application,” Moderna explained in a press release. The company argued that the letter is inconsistent with previous communications.
