FDA advisers recommend using omicron Covid injections for all doses

The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing the original Covid vaccine from Pfizer and Moderna used in the United States for each other’s first two vaccinations with the new bivalent omicron vaccines.

If the FDA accepts the advisers’ recommendation, the United States would likely eliminate companies’ vaccines developed in 2020 against the original strain of Covid-19 that emerged in Wuhan, China.

Instead, bivalent omicron vaccines from drugmakers that target the omicron BA.5 subvariant as well as the parent strain would be used for the entire series of vaccinations.

Currently, Pfizer and Moderna’s omicron injections are only allowed as a booster, while the first two doses are still their old injections based on the original Covid strain.

The 21 committee members unanimously backed the proposal, agreeing it would simplify the US Covid vaccination program.

“It’s absolutely the right thing to do for the program. It will make things easier,” said Dr. Melinda Wharton, senior official at the National Center for Immunization and Respiratory Diseases, a division of the Centers for Disease Control and Prevention.

The proposed change would only affect people who have not yet received their two-dose primary series. No timeline was provided on when this change might occur if the FDA accepts the panel’s non-binding recommendation.

The recommendation to adopt a single formulation for all doses comes as the FDA tries to streamline Covid vaccination so that the system is easier for the public and health workers to understand.

“The general idea here is that getting to a vaccine composition for everyone will ultimately be much, much more helpful,” said Dr. Peter Marks, who heads the FDA’s vaccines division.

The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu vaccines each year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in fall and winter. This formulation would be used by all manufacturers for all doses.

According to the proposal, most people who have been exposed to the Covid spike protein twice, either through vaccination or infection, would only receive one Covid vaccine per year in the future. Older people and people with weakened immune systems may need two injections because their immune response is not as strong.

Marks said the goal was to roll out updated Covid and flu vaccines at the same time in the fall to allow people to easily get vaccinated in one visit. This could help increase vaccination coverage and reduce the burden on hospitals as they simultaneously deal with the circulation of Covid, influenza and respiratory syncytial virus, he said.

“The benefit of this is also that if we can see the flu vaccine and the Covid-19 vaccine happen in the same visit, it facilitates a vaccination program which can lead to more people getting vaccinated and to be protected and reduce the amount of disease we see,” Marks told committee members.

But committee member Dr Cody Meissner, a pediatrician at the Geisel School of Medicine, said it was too early to say whether an annual Covid vaccination was needed.

Panel member Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said flu and Covid differ in important ways when it comes to vaccination.

If the flu shot doesn’t match the dominant variant, you don’t have much protection, Offit said. But Covid vaccines still protect well against serious illnesses, he said.

“I think we have to define what we want from this vaccine,” said Offit, who repeatedly emphasized preventing serious disease rather than mild disease.