FDA Advisory Board Endorses Updating COVID Vaccines to Target Newest Omicron Variant

The COVID-19 vaccines are set for a significant update this fall.

Currently, the vaccines still contain the original strain of the coronavirus, which started the pandemic. However, mutated versions of the virus have since emerged and become dominant.

On Thursday, the Food and Drug Administration’s scientific advisers recommended that the next round of shots in the U.S. should only protect against the newest variants, specifically the XBB branch of the omicron family tree.

The FDA will make the final decision, and vaccine manufacturers have stated that they could have updated vaccines available within a few months, depending on the strain.

While there has been a decline in infections, there is concern that the virus could pose a significant threat next winter, especially as it continues to evolve and immunity wanes.

Here are some key points to know:

The FDA had already informed the public to expect an updated COVID-19 vaccine in the fall, similar to the annual flu shot. Despite previous infections or vaccinations, the coronavirus continues to generate new variants.

The current vaccines in use in the U.S. are combination shots from Pfizer and Moderna, which protect against the original strain as well as last year’s omicron variants. However, only a small percentage of Americans have received a combo booster.

Although the FDA did allow seniors and high-risk individuals to receive an additional booster dose earlier this year, most people will have gone several months without a vaccination by the time fall arrives.

While the available vaccines still provide some protection against severe disease and death, their effectiveness decreases over time and they may not be as effective against milder infections or the new XBB variants.

As one adviser, Dr. Eric Rubin, noted, “We need a better vaccine. We should be updating it.”

Previously, when regulators were deciding how to update the vaccine, a combination shot seemed like the safest choice. However, this approach has a downside called “imprinting,” where the immune system becomes more responsive to the original strain than the new booster dose.

The FDA advisory panel agreed that the fall shot should specifically target the XBB variants. This recommendation aligns with those recently made by the World Health Organization and European regulators.

Another challenge is determining which XBB variant to target, as the virus is expected to continue mutating. Regulators will have to make their best guess, similar to how they formulate the fall flu vaccine each year.

A key question is whether older adults and high-risk individuals with weak immune systems should receive a single fall shot or be eligible for multiple doses. Additionally, it is uncertain how many doses young children who have never been vaccinated would require.

The final recommendations on updated shots and their timing will be made by the Centers for Disease Control and Prevention.

This content is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group. The Associated Press is solely responsible for its content.