Given Kennedy’s unfounded hostility toward mRNA technology and his work to undermine objective vaccine review at CDC, ACIP and FDA… this week’s FDA advisory committee meeting was a surprise.
FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of Moderna’s new mRNA flu vaccine, called mFlusiva, outweigh its risks for adults 50 and older.
Most influenza vaccines are still made using eggs. The egg process works but it’s real slow and when strains change in the Northern Hemisphere summer (S Hemisphere Winter) there’s not enough time to adjust the vaccine antigens.
mRNA vaccines use a different method which makes it a lot faster and also offers a chance to update influenza vaccine makeup for new late arriving strains.
At first, I was shocked at the news that VRBPAC was objective in their review. But then it made more sense when I found out that Kennedy hasn’t (yet) completely stacked the makeup of VRBPAC (yet).
FDA reviewers looked at effectiveness, immune response and safety of the new mRNA influenza vaccine in the clinical trials.
In adults over 50 it worked better than a standard-dose flu vaccine. In people 65 and over it had a better immune response than even the high-dose Egg technology) vaccine.
The side effects were sore arms, fatigue and similar short-term reactions to comparison vaccines. Most were mild to moderate and lasted about two days.
FDA reviewers found no clear safety signal in the larger safety database. Serious adverse events, deaths and adverse events of special interest were balanced between the mRNA vaccine and comparison groups.
What Happens Next
Under normal circumstances, FDA would now finish its review and decide whether to approve the vaccine. The expected decision date is in early August.
If FDA approves it, the next normal step would be for CDC’s ACIP to review the vaccine and decide how it should be recommended. ACIP would consider who should get it, whether it should be preferred for any age group, and how it fits with other flu vaccines. Once adopted by CDC leadership, that recommendation becomes official CDC policy.
That’s the rub then. Kennedy’s chokepoint for the vaccine will likely be at the ACIP which is now largely stacked with anti-vaccine zealots.
