FDA committee set to discuss strain selection for next round of COVID-19 boosters

While demand for COVID-19 vaccines has plummeted throughout 2023, healthcare officials remain focused on ensuring that the most effective shots are available for those who need them.

As part of that effort, outside experts on the FDA's Vaccines and Related Biological Products Advisory Committee are meeting June 15 to discuss strain selection for the upcoming fall booster campaign.

In a briefing document ahead of the meeting, FDA staffers said the next slate of vaccines should target a single variant within the XBB parent lineage. If U.S. healthcare officials do indeed take that route, that would be a departure from the bivalent booster vaccines that debuted last year.

A development from the earlier omicron variant, XBB and its subvariants are responsible for nearly all COVID-19 cases in the U.S., according to the latest data from the Centers for Disease Control and Prevention (CDC).

Thursday's FDA advisory committee meeting is just one step in the regulatory process for the next generation of COVID-19 vaccines. Last month, advisers to the World Health Organization recommended that new COVID-19 boosters target XBB subvariants, Reuters points out. And regulators in Europe are on board with the strategy.

In the U.S., the FDA will take its advisers' views into account when it makes the call for the fall booster target. And the CDC's Advisory Committee on Immunization Practices will also likely weigh in. That group will discuss the latest data on COVID-19 vaccines at its meeting next Friday, according to a draft agenda (PDF).

Already, vaccine makers are working on updated vaccines targeting the XBB.1.5 subvariant and others, according to Reuters. The current mRNA boosters target the original virus strain plus the omicron BA.4 and BA.5 variants, according to the CDC.

As COVID-19 has eased over the last year, revenues for the top vaccine makers have rapidly declined. Early this year, Pfizer warned that sales from its top-selling COVID countermeasures would fall by nearly two-thirds in 2023. Moderna is seeing a similar sales decline.