The US Food and Drug Administration (FDA) approved Moderna’s influenza vaccine for older adults on Wednesday. The vaccine, which will be marketed as mFlusiva, is the first licensed flu shot produced using messenger RNA (mRNA) technology.
The FDA issued a standard approval for the vaccine for use in adults aged 50 to 64, while an accelerated approval was granted for adults 65 years and older.
Lower likelihood of contracting test-confirmed influenza in adults aged 50-64 compared to the standard-dose comparator.
In the 50 to 64 age group, trial participants receiving the Moderna vaccine were 27% less likely to contract test-confirmed influenza compared to those who received the standard-dose comparator. While safety profiles between the mRNA vaccine and the standard-dose comparator were similar, more side effects were reported in the mRNA vaccine group; most were described as mild and lasting one to two days.
The Phase 3 clinical trial for the vaccine was conducted across 11 countries. Moderna expects to have doses of the vaccine available before the upcoming flu season.
Flu is a challenge, and mFLUSIVA provides an important new option for America’s seniors.
Regulatory background and trial requirements
The approval follows a series of regulatory events. In February, the FDA’s head of biologics at the time, Vinay Prasad, issued a refusal-to-file notice to Moderna because the agency would not review the vaccine based on the available data package. This decision was reversed a week after Moderna disclosed the FDA decision and its own concern. Vinay Prasad left the FDA at the end of April.
In June, an expert panel advising the FDA on vaccines voted unanimously that the benefits of the vaccine outweighed any risks. As part of the approval for those aged 65 and older, Moderna has agreed to conduct a Phase 4 post-licensure trial to gather more effectiveness data, specifically comparing mFlusiva to existing high-dose or adjuvanted vaccines.
Global expansion and manufacturing
MFlusiva is Moderna’s fourth vaccine to enter the US market. The vaccine has been accepted for regulatory review in the European Union, Canada, and Australia, with plans to submit for review in additional countries later this year.
MRNA vaccines can be manufactured significantly faster than traditional egg-based or cell-based vaccines, which allows for potential updates to targeted strains closer to flu season.
