By Puyaan Singh and Christy Santhosh
May 22 (Reuters) - U.S. Food and Drug Administration
advisers unanimously recommended on Thursday that COVID-19
vaccines for the 2025-26 period should target newer strains of
the JN.1 variant.
COVID vaccine makers are seeing increased regulatory
scrutiny under the new FDA leadership, facing tighter
requirements for their shots that could increase expenses.
FDA Commissioner Martin Makary and top vaccines
regulator Vinay Prasad have both been critical of current U.S.
COVID vaccine policies and have indicated that they were under
review.
The panel's discussion on Thursday touched upon the
prevalence of various strains. Government data indicate that the
LP.8.1 strain - a subvariant of the previously recommended JN.1
strain - accounts for about 70% of total cases in the United
States.
"We cannot predict the future very far out, but it does seem
like (targeting) LP.8.1 is likely to provide us better
coverage," said panelist Eric Rubin, adjunct professor at
Harvard T.H. Chan School of Public Health.
Shares of vaccine makers Novavax ( NVAX ) closed 2.5%
higher, Moderna ( MRNA ) 3.6% higher, while those of Pfizer ( PFE )
closed nearly flat.
The advisory panel also emphasized the need for frequent
reviews, given that the dominant strain could change again.
"This virus is still continuing to mutate ... It might be
worthwhile to take another look [at vaccine composition] ...
particularly for those for whom we are already recommending two
doses during the year," said Archana Chatterjee, dean of Chicago
Medical School.
However, the committee cautioned that updating vaccines more
than once a year would be unfair to manufacturers.
Novavax ( NVAX ) said on Thursday it was prepared to manufacture an
updated vaccine in time for the vaccination season.
Pfizer ( PFE ) and its partner BioNTech expect to supply
the vaccine immediately upon approval, while Moderna ( MRNA ) hopes to
launch it by mid-August.
Based on the panel's discussion, the FDA will soon decide
which strain the vaccine makers should target.