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US advisers to consider RSV shots as GSK looks to keep market lead

Wed, 26th Jun 2024 11:00

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 and new entrant Moderna 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 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 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 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 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 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 and $370 million this year for Moderna.

Pfizer 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 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 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. (Reporting by Michael Erman; editing by Caroline Humer and Bill Berkrot)

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