FDA: Single dose of bivalent COVID vaccine enough for most people

The Food and Drug Administration (FDA) on Tuesday announced it was simplifying its recommended COVID-19 vaccine schedule, stating a single dose of the bivalent vaccine specific to the BA.4 and BA.5 strains of the omicron variant is enough for most individuals.

Going forward, the FDA announced all coronavirus vaccines administered to those 6 months and older would be the bivalent doses. The original forms of the COVID-19 vaccines from Pfizer and Moderna are no longer authorized for use in the U.S., the agency said.

The announcement on Tuesday indicates a shift away from the two-dose vaccine schedule that has become the standard throughout the U.S. when it comes to mRNA vaccination. Johnson & Johnson’s coronavirus vaccine was originally the only authorized shot in the U.S. that was administered in a single dose.

According to the FDA, individuals who haven’t gotten a bivalent shot yet or haven’t gotten vaccinated at all are still eligible for a dose, but those who have received a single dose already are “not currently eligible for another dose.”

The agency says it plans to make further decisions on vaccination recommendations in June regarding the fall strain composition of the COVID shot.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Marks said evidence indicated that most of the U.S. population has antibodies against COVID-19, either from prior infection or immunization.

“The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death,” Marks added.

While most people who haven’t received a bivalent dose are eligible for one shot, certain groups of are still able to get more than a single dose.

People over the age of 65 who have received one bivalent dose are eligible for another at least four months apart. Immunocompromised individuals who have already received one dose may also get an additional immunization at least two months after, with additional doses permitted at the “discretion” of their healthcare provider.

Unvaccinated children between the ages of six months and five years are also eligible for a two-dose schedule of Moderna’s updated bivalent vaccine or a three-dose schedule of Pfizer’s version.

Children who are five years old may receive two doses of the Moderna shot or a single dose of Pfizer’s.

Updated at 10:26 a.m.