FDA to approve Omicron bivalent boosters this week.

The WSJ is reporting that the FDA is expected to approve the Omicron-specific bivalent coronavirus boosters this week. Shots in arms potentially as soon as Labor Day.

The WSJ article frames it like the FDA is only relying on animal data, but that isn't very accurate. The FDA has human data for previous Omicron sub-variant BA.1 bivalent vaccines from both Moderna and Pfizer. We are only lacking human data for the BA.5 vaccines.

And as Califf notes here, we have significant real world safety data for the previous coronavirus vaccines. They are extremely safe. Updating the vaccines isn't expected to change that strong safety profile. This is how the influenza vaccine is updated each season to target the expected influenza strains.

VRBPAC will not meet before the FDA approval.