YourLocalEpidemiologist: “A slippery slope that could hurt vaccine innovation: Moderna vs. a new FDA.” Last week, Moderna asked the FDA to review its new mRNA flu vaccine after completing a large clinical trial. Instead of reviewing it, the agency sent a “Refuse to File” letter. Fortunately, due to overwhelming outcry from the general public + research establishment, this was quickly reversed. Flu vaccines are imperfect. Most years they reduce the risk of hospitalization by roughly 40–60%—but compare that to the measles vaccine, which achieves 97% effectiveness against severe disease. Katelyn Jetalina lists 2 advantages of mRNA technology:
“[1] Speed: mRNA vaccines can be updated much faster than traditional flu vaccines (3 months vs. 6 months), so they could catch up to flu mutations more quickly.”
“[2] Immune response: Early research suggests stronger immune responses, including T cell and memory B cell responses that were comparable to or stronger than those from enhanced flu vaccines used in older adults.”
“So, Moderna invested an estimated $500–700 million to develop a new mRNA flu vaccine candidate, called mRNA-1010, and tested it in a Phase 3 trial involving more than 40,000 adults age 50 and older.’ The study compared the mRNA vaccine with a standard licensed flu shot. “Results showed 26% better protection in adults over 50 with the mRNA flu vaccine than with standard flu shots, a meaningful gain. Side effects such as fatigue + chills were more common (as they are with mRNA Covid-19 vaccines).”
Note that other regulators—such as those in Europe, Canada, and Australia—have agreed to accept the application. If our FDA slow-walks the whole process then the U.S. will fall behind the world. Most countries I suspect would then have the privilege of receiving the novel mRNA vaccine while Americans would not be able to receive the new vaccine in time for next winter. This would be in dramatic contrast to how quickly the covid-19 vaccine was developed in that epidemic.
