A federal vaccine advisory panel has given its stamp of approval to Moderna’s mRNA influenza vaccine, mRNA-1010. CIDRAP has the news.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to “recommend approval of the investigational vaccine, which will be marketed under the brand name mFlusiva, for the prevention of flu in adults age 50 to 64.” Moderna will be required to conduct a phase 4, post-marketing study to demonstrate effectiveness in adults aged 65 and older.
The FDA changed course in February after agreeing to review Moderna’s application for the vaccine, saying the phase 3 trial for mRNA-1010 was inadequate because it used a “standard-dose seasonal flu vaccine as the comparator vaccine.” A week later, the FDA reversed course once again. Now, it looks like the vaccine candidate will be able to move forward with testing and studies.
The trial reviewed by VRBPAC found that the vaccine “provided significantly better protection against flu-like illness than standard-dose shots, with a relative vaccine efficacy of 27%.” VRBPAC member Flor Munoz-Rivas said the data “support that the benefits of the vaccine in both age groups [aged 50 to 64 and ages 65 and older] outweigh the risks.”
