May 22 (Reuters) - The U.S. Food and Drug
Administration's advisory panel is set to vote on Thursday to
recommend whether COVID-19 vaccines for the 2025-2026
immunization campaign should target strains of the virus
descending from the JN.1 variant.
According to the Centers for Disease Control and Prevention,
the LP.8.1 strain - a subvariant of the previously recommended
JN.1 strain - accounted for 70% of total cases in the U.S. over
a two-week period ended May 10.
While the LP.8.1 is the predominant circulating strain,
other virus subvariants, including LF.7 and XFG, have also been
increasingly detected in recent weeks,
FDA documents showed earlier this week.
Public health experts say that there is no certainty on
which strains are going to be dominant. The strain selection
process is "intelligent guesswork," Sten Vermund, dean of the
University of South Florida College of Public Health, told
Reuters ahead of the advisory committee meeting.
Top U.S. vaccine regulator Vinay Prasad and FDA Commissioner
Marty Makary, both of whom have been critical of U.S. COVID
vaccine policies, said the benefit of repeated annual shots for
healthy adults remains uncertain after several years of the
virus circulation and vaccine availability.
Earlier this week, the FDA said it plans to require new
clinical trials for approval of annual COVID-19 boosters for
healthy Americans under age 65.
"You would need a huge clinical trial that is very costly
and you wouldn't finish it in time for the COVID virus season,"
Vermund told Reuters.
FDA's Prasad said he was open to hearing the thoughts of the
vaccine advisory panel on the new policy.
Analysts have said the new clinical trials are reasonable
and may help alleviate investor concerns regarding vaccine
manufacturers as they maintain the existing framework for older
adults and at-risk individuals, who are typically the ones
seeking vaccinations.