FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses

The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the U.S. for everyone’s first two immunizations with the new bivalent omicron shots.

If the FDA accepts the advisors’ recommendation, the U.S. would likely phase out the companies’ vaccines developed in 2020 against the original strain of Covid that first emerged in Wuhan, China.

Instead, the drugmakers’ bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series.

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

The possible change would only impact people who have not yet received their two-dose primary vaccination series.

The 21 members of the FDA committee unanimously backed the recommendation, agreeing that it would simplify the U.S. Covid vaccination program.

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

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

“The overall thought here is that getting towards one vaccine composition for everyone will ultimately be much, much more helpful,” said Dr. Peter Marks, who heads the FDA’s vaccine division.

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

Under the proposal, most people who have been exposed to the Covid spike protein twice, either through vaccination or infection, would only receive one Covid shot a year moving forward. Older adults and people with compromised immune systems may need two shots because they don’t mount as strong of an immune response.

This is a developing story. Please check back for updates.