The FDA formally authorized (EUA) updated COVID-19 boosters this week.
BOTTOM LINE: We recommend that anyone who is eligible for this booster should get it.
- Two months after the last vaccine/booster is probably too soon, but about 4 months would be good.
- This delay recommendation could change depending on the initial data.
A major post-Labor Day vaccination push is planned by the CDC and the White House.
There are still approximately 450 deaths per day in the US with COVID (note that this is “with COVID” not necessarily “due to COVID”). Compare to between 30 and 150 for Flu, but flu is averaged over the whole year. At peak flu season, the number of flu deaths is comparable, if not higher.
No significant human testing has been done, but the FDA likens this to the annual approval without testing of the flu vaccine: same basic components, but with a small change in the antigen that improves effectiveness against antigenic variants
- A bivalent vaccine (original/BA1) was authorized/used earlier this year in the UK and it worked well. This finding figured into the FDA decision to approve this version (original / BA5).
While BA5 is the predominate circulating variant, the second is BA4 and it shares the same spike protein targeted by the vaccine with BA5, so this vaccine directly addresses >99% of circulating COVID.
- Specific activity against BA4.6 (7-8% of circulating variant is not quite as clear, but expected to be good).
The CDC is expected to recommend this new “bivalent” booster for anyone (age 12+) who has completed primary vaccination.
- The FDA authorization is for at least two months after completion of the primary series OR after the last booster.
- The CDC is expected to recommend waiting 4 to 6 months after the primary series or last booster although they mainly concur with FDA on only 2 months (this recommendation will be out Thursday later afternoon or Friday morning).
- For now, the bivalent vaccine cannot be used for primary vaccination.
The CDC issued an alert that they expect a surge in COVID cases in late fall and winter.
- This is only based on assumption that fall and winter weather drives an increase in all respiratory diseases and COVID should be no different. No other data driving this and no new variants are on the horizon.
- The timing of this announcement, directly coinciding with the authorization of the new vaccine, means that the timing is likely part of the booster marketing program, but the logic holds.