On Thursday, the Food and Drug Administration’s independent advisory panel recommended replacing the original Covid vaccines from Pfizer and Moderna used for the first two doses of immunizations in the United States with new bivalent Omicron shots.
If the FDA accepts the advisers’ recommendations, the United States could phase out a corporate vaccine developed in 2020 against the original strain of Covid that originated in Wuhan, China.
Instead, pharmaceutical company bivalent Omicron shots targeting the Omicron BA.5 subvariant and the original strain will be used for the entire vaccination series.
Currently, Pfizer and Moderna’s Omicron shots are only licensed as boosters, but the first two doses are still older shots based on the original Covid strain.
Twenty-one members of the FDA panel unanimously supported the proposal and agreed to simplify the Covid vaccination program in the United States.
“This is absolutely right for the program. It makes things easier,” said Dr. Melinda Wharton, senior official with the National Center for Immunization and Respiratory Diseases, a division of the Centers for Disease Control and Prevention.
The proposed changes will only affect people who have not yet received the first two vaccination series. If the FDA accepts the panel’s non-binding recommendations, no timeline was provided as to when this switch would take place.
The recommendation to adopt a single formulation for all doses comes as the FDA seeks to streamline Covid vaccination to make the system easier to understand for the general public and healthcare professionals.
Dr. Peter Marks, who heads the FDA’s Vaccines Division, said:
The FDA is proposing moving to a system similar to how the FDA updates and rolls out flu shots each year. Officials plan to select Covid vaccine formulations in June to target variants expected to predominate in the fall and winter. Its formulations are used by all manufacturers in all dosages.
Under the proposal, most people who have been exposed to the Covid spike protein twice through vaccination or infection will only receive one Covid vaccination in the next year. People with HIV may need two doses because their immune response is not as strong.
The goal, Marks said, is to roll out the latest Covid and flu vaccines simultaneously in the fall so people can easily get vaccinated in one visit. But it could reduce the burden on hospitals as they face simultaneous outbreaks of Covid, influenza and respiratory syncytial virus, he said.
“The advantage of this is that if we can see the flu vaccine and the Covid-19 vaccine done in the same visit, more people will be vaccinated and protected, reducing the amount of disease we see. It’s about facilitating vaccination programs that could lead to more,” Marks told committee members.
But panel member Dr. Cody Meissner, a pediatrician at Geisel College of Medicine, said it was too early to say whether annual Covid vaccinations were necessary.
Panel member Dr. Paul Offitt, a vaccine expert at Children’s Hospital of Philadelphia, said influenza and Covid differ in important ways when it comes to vaccination.
If the flu vaccine doesn’t match the dominant variant, Offitt said, it doesn’t provide adequate protection.
“I think we need to define what we want from this vaccine,” said Offitt, who has repeatedly emphasized preventing severe illness, not mild illness.