USA — As preparations for the 2023-2024 COVID-19 vaccination campaign get underway, the U.S. Food and Drug Administration’s (FDA) staff reviewers have recommended that the vaccines should target one of the currently dominant XBB variants.

These comments were made in documents released ahead of the FDA’s independent expert panel meeting, scheduled for Thursday, where recommendations will be made regarding the strain that an updated COVID-19 booster should focus on.

This recommendation aligns with the advisory group to the World Health Organization (WHO), which in May proposed that COVID-19 booster shots for the year should be updated to target XBB subvariants.

Last year’s COVID vaccine boosters in the United States included the original strain and the Omicron variant in a bivalent shot.

According to CDC data, approximately 17% of people in the United States received a COVID booster shot during the 2022-2023 vaccination season, as of early May.

COVID-related deaths in the country peaked in January but have since decreased, falling 14.3% in the past week.

Regulators emphasize the need to update vaccines to address the virus’s unpredictable nature. The FDA staff stated, “There is no indication that SARS-CoV-2 evolution is slowing down, though immunity appears to be mitigating severe clinical outcomes.”

The FDA’s reviewers recommend that the COVID vaccination campaign feature a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3.

They note that the proportion of XBB.1.5 cases is declining, while both XBB.1.16 and XBB.2.3 are on the rise.

By early June 2023, XBB subvariants accounted for more than 95% of circulating virus variants in the United States.

The upcoming strain selection will be crucial for companies aiming to compete in the fall when vaccine distribution is expected to shift to the private sector.

Consequently, Pfizer/BioNTech, Moderna Inc., and Novavax Inc. are already developing versions of their vaccines targeting XBB.1.5 and other currently circulating strains.

In a separate development, BioNTech is currently facing compensation claims in Germany brought by two law firms alleging lasting health damage resulting from the company’s COVID-19 vaccine.

While rare, peer-reviewed studies have documented side effects of COVID-19 vaccinations, including neurological complications and myocarditis, an inflammation of the heart.

BioNTech, a publicly listed company, expressed confidence that the claims would be dismissed and revealed that it has not set aside provisions to cover potential compensation claims.

Should a verdict be reached against BioNTech, the financial impact on the company is expected to be limited due to an EU legal shield that primarily holds national governments responsible for unforeseen side effects, providing protection to vaccine manufacturers.

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