US FDA Advisors to Rethink Whether to Target the JN.1 Variation in New COVID Vaccines

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Documents filed on Monday indicated that advisors to the U.S. Food and Drug Administration will cast a vote on whether to suggest that COVID-19 vaccinations for 2024–25 should focus on the JN.1 strain, which is the most prevalent this year.
Novav’s stock shot up 11% in early trading on the release of the documents. The business had stated last month that it would only be able to provide the COVID vaccination in the US this fall if officials approved the injection, it had begun producing to combat the JN.1 type.

In different documents, FDA staff stated that vaccine developers for the new booster injections would want to think about going after one of the JN.1 subvariants, such KP.2, since the virus might eventually evolve away from the older strain.
Prior to the advisers’ Wednesday meeting, the documents were made available online. The FDA requested more time to “obtain surveillance data and other information” regarding the circulating virus, thus the meeting was rescheduled from May 16.
The World Health Organization’s advisors, who suggested in April to focus solely on the JN.1 strain, have a different review process than the FDA staff when it comes to upgrading virus strains for vaccinations in the United States.

Since then, according to statistics from the U.S. Centers for Disease Control and Prevention, the subvariant KP.2 has emerged as the predominant strain in the country, accounting for an estimated 28.5% of cases during a two-week period ending on May 25.