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FDA's latest COVID vaccine guidance: Get a bivalent dose

A person with dark nail polish and rings pushes a syringe into a person's shoulder
Gabriel C. Pérez

The Food and Drug Administration has unrolled a new slate of simplified recommendations for vaccination against COVID-19, which were confirmed by the Centers for Disease Control and Prevention on Wednesday.

Since the first vaccines were made available in late 2020, the COVID vaccination schedule has become more complex. First, folks were recommended to get a two-dose series of the Pfizer or Moderna vaccines, then a one-dose shot became available from Johnson & Johnson, then booster shots were encouraged, followed by bivalent booster shots, which offer protection against both the original strain of COVID and the omicron variants.

As of Tuesday, the FDA’s guidance is more straightforward: Get a bivalent Pfizer or Moderna dose if you haven’t already.

Because the bivalent vaccines offers markedly better protection against the current leading strains of the virus, the FDA has revoked the emergency use authorizations for the original monovalent ones.

People who have not received a bivalent dose will no longer be considered fully vaccinated, even if they received the initial two-dose series of Pfizer or Moderna vaccines. According to CDC officials, that means most Americans are not up-to-date on their COVID vaccinations.

“Four out of five adults have not yet received a bivalent mRNA vaccine and are not up to date with COVID-19 vaccination at this time,” Dr. Evelyn Twentyman, a CDC official, said Wednesday during a presentation to the CDC’s Advisory Committee on Immunization Practices.

When is it time for another shot?

Adults who have never received a bivalent booster can do so at any time — and the FDA recommends it. People who have never been vaccinated can now be considered fully vaccinated after a single bivalent Pfizer or Moderna dose.

Recommendations differ slightly for children: kids aged 6 months to 5 years who haven’t yet received any COVID vaccine can receive either two doses of the Moderna bivalent or a single dose of the Pfizer bivalent vaccine.

Those over 65 who received a bivalent booster four or more months ago can choose to get another dose this spring. Immunocompromised individuals can receive an additional booster every two months, or at the discretion of a health care provider.

Folks who already received a bivalent booster and do not fall into either of these groups, however, have not been given the green light to receive an additional booster yet.

Locally, Austin Public Health says it will update its own recommendations following a review by the Texas Department of State Health Services.

A spokesperson for APH expressed support for the changes.

“This new guidance makes it easier and quicker to get up to date with your COVID-19 vaccines,” William Malm said.

Annual booster shots?

The FDA has indicated that there may be a booster recommended for everyone this fall, which could be the first in an annual series. The agency is set to discuss the matter in June, following a study of which COVID strains may dominate in the coming months. This would create a similar process and schedule as exists for annual flu shots.

“We know that a simplified, annual recommendation could help reduce vaccine and message fatigue. A plan for a fall booster dose could provide added protection at a time when many would be about a year from their last dose,” CDC official Dr. Sara Oliver said Wednesday.

What about other COVID vaccines?

Two additional vaccines are still authorized for use in the United States: Novavax and Johnson & Johnson. However, the FDA currently recommends these vaccines for use only when a patient either cannot receive a bivalent mRNA vaccine for clinical reasons or refuses to get one.

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Olivia Aldridge is KUT's health care reporter. Got a tip? Email her at Follow her on X @ojaldridge.
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