Story at-a-glance
- August 31, 2022, the U.S. Food and Drug Administration authorized Pfizer’s and Moderna’s bivalent boosters, which will be available to those who have received the primary two-dose series
- Pfizer is releasing a bivalent injection targeting Omicron subvariants BA.4 and BA.5, which are the two currently in circulation. Moderna’s bivalent booster targets the already extinct Wuhan strain and Omicron subvariant BA.1
- The reformulated COVID boosters will be rolled out without safety or effectiveness data from human trials. They’re being green-lighted based on antibody data from mice alone, even though antibody levels tell us nothing about effectiveness
- According to the FDA, the reactogenicity profile of Pfizer’s reformulated shot is “overall similar to prototype BNT162b2 vaccine,” and VAERS data prove that’s hardly a selling point
- This fall, health agencies will also push the seasonal flu shot, and all flu vaccines will be quadrivalent this year, meaning they contain antigens against four influenza strains. Seniors may be at greatest risk for vaccine injury, as they will get a high-dose quadrivalent flu vaccine
As the U.S., U.K. and other countries around the world prepare for a fall vaccination campaign against both the flu and COVID, it’s worth taking note of some basic facts. In “Untested Bivalent COVID Jab Being Rolled Out,” I reviewed potential problems with Moderna’s new bivalent COVID shot for adults, authorized by the U.K. in mid-August 2022.
August 23, 2022, Pfizer and Moderna submitted their respective authorization requests to the U.S. Food and Drug Administration.1 Pfizer is releasing a bivalent injection targeting Omicron subvariants BA.4 and BA.5, which are the two currently in circulation, while Moderna’s shot targets the already extinct Wuhan strain and Omicron subvariant BA.1.2
