FDA Advisers Considering Updating COVID Vaccine for New Subvariant
FDA advisers will review antibody data and vote on whether manufacturers should make an XFG shot for the 2026-2027 COVID season.
- On Thursday, the FDA's vaccine advisers will vote on whether an XFG monovalent vaccine should be preferred for COVID-19 shots for the 2026-2027 season, with presentations examining antibody responses and immunogenicity data from updated vaccine candidates.
- XFG's emergence as the dominant variant prompted the review, with CDC data showing it accounted for a majority of U.S. cases through April, following the WHO's recommendation earlier this month for LP.8.1 vaccines.
- While XFG remains dominant, BA.3.2 reached 30% prevalence in some European countries and carries more than 70 spike protein mutations relative to JN.1 descendants; Pfizer, Moderna, and Sanofi have all indicated they are prepared to produce an XFG vaccine for next season.
- VRBPAC will evaluate phenotypic evidence showing BA.3.2's reduced fitness and the WHO's findings that it poses no substantial disease increase despite higher pediatric prevalence, determining whether the variant warrants vaccine inclusion.
- The vaccine decision occurs under new acting Commissioner Kyle Diamantas following Dr. Marty Makary's resignation, as Stony Brook Medicine notes XFG's paradoxical biology—weaker cell penetration but superior immune escape.
19 Articles
19 Articles
FDA Considers Updated COVID Jab
The Food and Drug Administration (FDA) is weighing whether to update the COVID-19 vaccine in the fall. The FDA Vaccines and Related Biological Products Advisory Committee will meet this week and consider whether the inoculation should be updated to target XFG variants. “Recommendations for updating the strain composition of COVID-19 vaccines must consider the time needed for manufacturers to implement and deliver an updated COVID-19 vaccine form…
FDA Vaccine Panel to Consider Reformulating COVID-19 Vaccines
The Food and Drug Administration’s panel of vaccine advisers will consider which COVID-19 strains the agency should direct manufacturers to target in the fall. The FDA Vaccines and Related Biological Products Advisory Committee is scheduled to meet on May 28 and vote on whether vaccines should be reformulated to target XFG variants. The FDA has for years been advising companies to update shots annually, to try to address lower and waning effecti…
FDA's Vaccine Panel to Weigh XFG Variant for New COVID Shots
(MedPage Today) -- The FDA's vaccine advisors will meet Thursday to vote on whether an XFG monovalent vaccine should be preferred for COVID-19 shots for the 2026-2027 season. The Vaccines and Related Biological Products Advisory Committee (VRBPAC...
FDA advisers to weigh updated COVID vaccine targeting XFG subvariant
The Food and Drug Administration’s (FDA) advisory committee on vaccines this week will consider whether to change the COVID-19 vaccine to target the XFG subvariant for the upcoming 2026-2027 respiratory viral season. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Thursday to discuss whether COVID-19 vaccines should target the NB.1.8.1…
FDA to Weigh Updating COVID Shots for XFG Variant
US FDA advisers to weigh updating 2026-27 COVID vaccines for XFG variant
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