FDA advisors recommend use of Covid omicron vaccinations for all doses

The FDA’s independent advisory committee on Thursday recommended replacing the original Covid vaccine from Pfizer and Moderna used in the US for the first two immunizations with the new bivalent omicron shots.

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

Instead, bivalent omicron vaccines targeting the omicron BA.5 subvariant as well as the parent 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 streamline the U.S. Covid vaccination program.

“This is absolutely the right decision for the program. It will make things easier,” said Dr. Wilson. Melinda Wharton is a senior fellow at the National Center for Immunization and Respiratory Diseases, a division of the Centers for Disease Control and Prevention.

The proposed change will only affect people who have not yet received the two-dose primary vaccination. A timeline for when this switch could occur if the FDA accepts the panel’s non-binding recommendation is not provided.

The recommendation to use a single formula for all doses comes as the FDA is trying to simplify Covid vaccination so that the system is more understandable to the public and healthcare professionals.

“The general thought here is that developing a single vaccine formulation for everyone will ultimately be much more beneficial,” the doctor said. Peter Marks, head of the FDA’s Vaccine Division.

The Food and Drug Administration (FDA) has proposed switching to a system similar to how the agency renews and releases flu shots every year. The agency will select a Covid vaccine formulation in June to target a variant expected to dominate the fall and winter. This formulation will 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, will only receive one Covid shot per year going forward. Older people and people with weakened immune systems may need two injections because they don’t have such a strong immune response.

Marks said the goal is to roll out updated Covid and flu vaccines at the same time in the fall to make it easier for people to get vaccinated in one visit. This could help increase vaccination coverage and reduce the burden on hospitals as they simultaneously tackle the spread of Covid, influenza and respiratory syncytial virus, he said.

“The advantage of this is also that if we can see the flu vaccine and the Covid-19 vaccine appear during the same visit, it facilitates the vaccination program, which can lead to more people being vaccinated and protected, as well as reduce the number of observable diseases. “, Marks told the members of the committee.

But committee member D. Cody Meisner, a pediatrician at the Geisel School of Medicine, said it was too early to tell if an annual Covid vaccination is needed.

Panel member Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said the flu and Covid are very different when it comes to vaccinations.

If the flu vaccine doesn’t match the dominant variant, you don’t have enough protection, Ofit said. But Covid vaccines still provide good protection against severe illness, he said.

“I think we need to define what we want from this vaccine,” said Offit, who has repeatedly emphasized preventing severe disease over mild disease.