FDA moves to simplify COVID vaccination guidance, says second bivalent boosters ok for some

Federal health authorities are working to simplify COVID-19 vaccination recommendations. People older than 65 and those who are immunocompromised may soon be eligible to get a second dose of the updated bivalent boosters. They were rolled out late last year and were changed to protect against the latest COVID-19 variants.

The FDA said most people who are vaccinated, but have not gotten the updated Pfizer or Moderna bivalent vaccines, can get a single dose. Those 65 and older can get an additional booster at least four months after their first dose, and those who are immunocompromised can get another booster at least two months after.

The guidance is pending CDC approval, which could come later this week. The updated vaccines do not prevent infections, but they will reduce risk post-infection.

“Data after data has shown that one, you are protected from getting severe disease and hospitalization and death,” said Dr. Francesca Torriani, program director for infection prevention and clinical epidemiology at UC San Diego Health. “Second, your chances of getting long-haul COVID or other complications are much lower if you’re up to date on your vaccines.”

Protection wanes over time and there may be new variants each year, which means the vaccines could be updated each season. There is currently no annual recommendations for COVID-19 vaccines, but that topic is set to be discussed by an FDA advisory committee in June. Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said in a news conference Tuesday they are moving in the direction of seasonal vaccines.

“It’s going to be simple. It's essentially a single dose of the appropriate strain vaccine as we move into the fall and winter months,” Marks said.

Marks said part of the idea is to increase vaccination rates for those at highest risk. He said 42% of those 65 and older have gotten the updated bivalent boosters and that the older population could see doses recommended every six months.

Torriani said it is unclear what the public's appetite may be for seasonal COVID-19 vaccines, but said the message from health leaders has to be clear and concise.

"It will dependent on a very good vaccination campaign — meaning really showing what the science behind it is and what the results have showed," Torriani said. "I think that certain populations will definitely be favorable to getting this update and it's a question of it becoming culture."

FDA reports almost all Americans 5-years and older have some protection from COVID-19 either from previous vaccinations or infections. Most people under 65 who have gotten one bivalent booster are not eligible for a second dose yet. San Diego County is still holding pop-up vaccination sites. The county’s COVID-19 website shows each day where different vaccination events are being held.