FDA and CDC simplify COVID-19 vaccine guidance

This week, the FDA made some adjustments to the U.S.’s COVID-19 vaccine guidance in order to standardize all new mRNA shots to bivalent (or Omicron-specific) vaccines, and to allow adults at higher risk to receive additional boosters. The CDC’s vaccine advisory committee and Director Rochelle Walensky both endorsed these changes.

Here are the main updates you should know. For more details, I recommend reading Helen Branswell’s reporting in STAT News and/or Katelyn Jetelina’s coverage in Your Local Epidemiologist.

• Adults are now considered “up to date” on their COVID-19 vaccines if they have received at least one dose of a bivalent/Omicron-specific vaccine. These are the vaccines manufactured by Pfizer and Moderna that became available last fall.
• Any unvaccinated adult should receive one dose of a bivalent vaccine, rather than the former primary series (which was based on the original coronavirus strain). The prior vaccines will essentially go out of use in the U.S.
• Seniors (65 or older) and immunocompromised adults may receive an additional bivalent vaccine dose, starting at four months after their prior dose. Recent research has demonstrated that protection from these shots wanes over a couple of months, so there’s a good case for seeking out a new booster if you fall into one of these high-risk categories.
• Immunocompromised adults may receive more bivalent doses going forward, in consultation with their doctors. This guidance intends to provide more protection to people who are severely immunocompromised, such as those undergoing cancer treatment.
• A new version of the bivalent booster will likely be available in the fall, designed to protect against more recent coronavirus variants. We don’t know much about this yet, but prior FDA and CDC meetings have suggested it will roll out on a similar schedule to the annual flu shot.

These recommendations mostly apply to adults. While the FDA and CDC are also working on simplifying their guidance for children (to similarly prioritize vaccines aligned to current variants), that’s still a more complicated situation right now. See the YLE post for more details.

Another open question, at the moment, is what non-mRNA vaccines may be available, for people who may be allergic to those vaccines or who had severe reactions to earlier doses. Novavax is reportedly working on a bivalent/Omicron-specific option, which people might be able to get this fall. The Johnson & Johnson vaccine is no longer widely used at all.

It makes sense for the FDA and CDC to shift towards bivalent vaccines. Numerous studies have demonstrated that these vaccines perform better against Omicron variants, and this move simplifies the immunization process for everyone involved (doctors, pharmacies, patients, etc.).

However, this shift reveals how poorly the bivalent booster rollout has gone in the U.S. so far. Only 17% of the population has received one, compared to 81% who’s received at least one dose overall, according to the CDC. Even among seniors, only 42% have received a bivalent booster. It would be a massive task for the country to move towards “up-to-date” coverage among all adults.

And the federal government doesn’t appear to be pushing for this in any meaningful way. I’ve already seen several reports on social media of people trying to get an additional booster, and failing—whether because of an insurance issue or because pharmacies have simply stopped offering the shots. This process will only get more challenging when the federal public health emergency ends next month. While the Biden administration has announced funding to cover vaccines for uninsured Americans, that’s just one hurdle among a growing number.

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