FDA advisors recommend the use of Omicron COVID shots for all doses

The Food and Drug Administration’s independent advisory panel on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the United States in everyone’s first immunization with new bivalent Omicron shots.

If the FDA accepts the advisors’ recommendation, the US will likely phase out corporate vaccines developed in 2020 against the original Covid-19 strain that emerged in Wuhan, China.

Instead, bivalent omicron shots from pharmaceutical companies targeting the omicron BA.5 variant as well as the original strain will be used for the entire vaccination series.

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

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

“This is absolutely the right thing to do for the program. It will make things simpler,” said Dr. Melinda Wharton, a 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 the initial two-dose vaccination series. No timeline has been provided for when this switch will occur if the FDA accepts the committee’s non-binding recommendation.

The recommendation to adopt a single formulation across all doses comes as the US Food and Drug Administration tries to simplify the Covid vaccine so that it is easier for the public and healthcare workers to understand.

“The general idea here is that eventually getting to one vaccine formulation for all will be much more beneficial,” said Dr. Peter Marks, who heads the FDA’s vaccine division.

The US Food and Drug Administration (FDA) has proposed moving to a system similar to how the agency updates and releases flu vaccines each year. The agency will choose a Covid vaccine formula in June to target the variant that is expected to prevail in the fall and winter. This formula will be used by all manufacturers for all dosages.

Under the proposal, most people who have been exposed to the Covid spike twice, either through vaccination or infection, will only get one shot of Covid each year from now on. Older adults and people with weakened immune systems may need two injections because they do not have a strong immune response.

The goal, Marks said, is to roll out the updated Covid and influenza vaccines at the same time in the fall to make it easier for people to get their vaccines in one visit. He said this could help boost vaccine coverage and reduce the burden on hospitals as they simultaneously face the spread of Covid, influenza and respiratory syncytial virus.

“The advantage of this also is that if we can see the flu vaccine and the Covid-19 vaccine at the same visit, it facilitates a vaccination program that could lead to more people getting vaccinated and protected and reducing the amount of disease that we see,” Marks told panelists.

But panel member Dr. Cody Meisner, a pediatrician at Geisel School of Medicine, said it was too early to say whether an annual Covid vaccination is necessary.

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

If the flu vaccine doesn’t match the mainstream variant, Offit said, you don’t have much protection. But he said Covid vaccines still protect well against severe disease.

“I think we need to decide what we want from this vaccine,” said Offit, who has repeatedly emphasized prevention of severe disease rather than mild disease.

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