June 26 (Reuters) - A committee of outside experts to
the U.S. CDC are set to vote on whether to expand the age group
of adults who should receive respiratory syncytial virus (RSV)
vaccines this year, as GSK battles rival Pfizer ( PFE )
and new entrant Moderna ( MRNA ) to keep its top position in the
market.
The Centers for Disease Control and Prevention's Advisory
Committee on Immunization Practices will meet on Wednesday
through Friday to consider and recommend who should get RSV,
influenza and COVID-19 vaccines and how strong to make those
recommendations.
Although the CDC generally follows the committee's votes,
the final decision rests with the agency's director.
Last year, GSK's Arexvy and Pfizer's ( PFE ) Abrysvo went head to
head for adults over the age of 60. GSK won two-thirds of the
market, mostly due to its contracts with retail pharmacies,
including CVS. Moderna ( MRNA ) received approval for its shot,
mRESVIA, for the same age group last month.
Headed into this autumn, GSK has FDA approval to expand use
of its vaccine to adults ages 50 to 59, making it the first shot
endorsed for that age group.
Pfizer ( PFE ) said it submitted data for its shot in adults aged 18
to 59 and hopes to get the expanded approval as early as the
fourth quarter.
"Getting to that 50- to 59-year-old population early is
pretty meaningful," said Guggenheim Partners analyst Evan Wang.
"Not only does it add 10 to 15 million more high risk
individuals to the total pool, it also is significant because
... this could give them an edge as they kind of negotiate with
retail pharmacies for contracts," Wang added.
Unlike GSK, Pfizer ( PFE ) has started the contracting season with
an FDA approval in hand for pregnant women in order to protect
their babies. Last year, it did not receive the maternal
approval until late August, after the vaccination campaign had
begun.
RSV typically causes cold-like symptoms but is also a
leading cause of pneumonia in toddlers and older adults, leading
to 177,000 hospitalizations and 14,000 deaths in the United
States annually.
Combined revenue for the Pfizer ( PFE ) and GSK shots in their first
year of availability topped $2.4 billion.
Analysts, on average, expect sales of $1.59 billion for
GSK's RSV shot, $1.47 billion for Pfizer's ( PFE ) and $370 million this
year for Moderna ( MRNA ).
Pfizer ( PFE ) Chief Executive Albert Bourla has acknowledged that
Abrysvo had a "bad launch" last year, and company executives
have said they are focused on improving its performance.
Pfizer ( PFE ) recently secured a contract to supply close to 5
million doses of its vaccine in the UK over the next two years.
Britain-based GSK said it was disappointed not to have been
selected.
Protection from the Pfizer ( PFE ) and GSK shots have been shown in
trials to last at least two RSV seasons.
Analysts believe the market will grow from 2023, in part
because the companies have been marketing the shots directly to
consumers since last year.
"They definitely got the low hanging fruit last year, said
Morningstar analyst Damien Conover.
Guggenheim's Wang said he expects the market to be between
$2.5 billion and $3 billion this year.