FDA Vaccine Advisory Committee Votes Unanimously to Target JN.1 Family of Viruses for 2025-26 Covid-19 Vaccines

Strategic Insights -

The US Food and Drug Administration's (FDA) Vaccine and Related Biological Products Advisory Committee voted unanimously to recommend targeting the JN.1 family of viruses for the 2025-26 Covid-19 vaccines, giving the agency latitude to keep the current shots or update its formulas to more closely match circulating viruses. This decision was made amidst concerns about the potential impact on access to the shots, particularly for younger adults and children, due to the need for placebo-controlled clinical trials, which take longer and are expensive to run.

Key Takeaways:

  • The FDA advisory committee agreed that next respiratory season's shots should target the JN.1 family of viruses, which swept the globe last year.
  • The JN.1 family of viruses includes the Omicron sublineage KP.2, which was used to make the Pfizer and Moderna Covid-19 vaccines in the US last year, but is no longer circulating.
  • Vaccine manufacturers presented data showing that vaccination with JN.1-or KP.2-based shots continues to boost antibodies to protective levels, even against newer viruses with slightly different mutations.
  • The FDA will consider approving updated shots based on a newer member of the JN.1 family, LP.8.1, which is currently the dominant variant in the US.
  • The agency wants to see placebo-controlled clinical trials for Covid-19 vaccines in healthy younger adults and children, which could delay the vaccine's availability for this group.
  • FDA representatives stated that the goal is not to impact the timely availability of vaccines, but changing the targeted coronavirus strain might put the shots out of reach for some groups this fall.

Statistics:

  • 100%: The FDA advisory committee voted unanimously to recommend targeting the JN.1 family of viruses for the 2025-26 Covid-19 vaccines.
  • 1 year: The viruses that came before the JN.1 family, including the XBB lineage viruses, were circulating in the US.
  • 65 and older: The FDA will accept the same kind of study data it has been using to approve annual flu shots and updated Covid-19 vaccines for this age group and people with underlying medical conditions.
  • 30-40%: The boost in antibodies from vaccination with updated shots based on the LP.8.1 member of the JN.1 family is more robust compared to the current JN.1-or KP.2-based shots.

Sources:

  • CNN article by Brenda Goodman, "FDA advisory committee votes unanimously to recommend next Covid-19 vaccines target JN.1 family of viruses," CNN, [no date mentioned in the original text].
  • World Health Organization, "WHO advises continued use of JN.1 or KP.2-based Covid-19 vaccines," [no date mentioned in the original text].