FDA recommends new COVID vax composition

COVID-19 booster dose in hand stock photo.
Photo credit Getty Images

If you get a COVID-19 booster shot this fall, the U.S. Food and Drug Administration thinks it should include a component that specifically protects against the omicron variant of the SARS CoV-2 virus.

As of this week, U.S. Centers for Disease Control and Prevention data showed that omicron subvariants account for nearly all COVID-19 cases in the country. Subvariant BA.2.12.1 was behind 42% of cases and subvariant BA.5 was behind nearly 37% of cases.

An FDA advisory committee met Tuesday to discuss vaccines and “an overwhelming majority of the advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022,” said a press release from the agency.

A briefing document for the meeting said that the committee discussed “considerations that should inform strain composition decisions to ensure that available COVID-19 vaccines continue to meet public health needs,” earlier this year, including “when and how frequently to consider strain composition changes, and the process that should be used for making a recommendation for updating the vaccine strain composition.”

During the committee discussion, members addressed current data on the evolution of SARS-CoV-2 variants, effectiveness of currently available COVID-19 vaccines, and modeling predictions for the potential future evolution of the COVID-19 pandemic. They also considered recently released recommendations from the World Health Organization and immunogenicity data from clinical studies.

While COVID-19 vaccines already approved by the FDA – such as the Moderna and Pfizer mRNA vaccines – provide significant protection against severe illness, hospitalization and death, breakthrough infections may occur.
Additionally, the primary dose series of these vaccines were first developed before omicron became the dominant variant.

Recently, a group of scientists wrote a letter that said data indicates BA.2.12.1, BA.4, and BA.5 subvariants of omicron can escape neutralizing antibodies induced by both vaccination and infection.

“SARS-CoV-2, the virus that causes COVID-19, has evolved significantly, with recent surges around the world associated with the rapid spread of highly transmissible variants such as omicron,” the FDA explained.

Going forward, the administration advises vaccine manufacturers seeking to update their COVID-19 vaccines to develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine.

“These modified vaccines can potentially be used starting in early to mid-fall 2022,” the FDA said. According to the administration, the coming year is expected to be a “transitional period” for the pandemic. Thus far, they have not recommended changes to the primary series of doses, only booster doses.

Already, both Moderna and Pfizer have announced that they are developing vaccines that provide specific protection against omicron.