The U.K. drugmaker
GSK
is seeking to expand regulatory approval for its new respiratory syncytial virus vaccine to include younger adults, even as other manufacturers’ new RSV products face shortages across the U.S.
This fall marks the first respiratory virus season in which RSV vaccines are approved for certain age groups. The common respiratory virus, which generally causes mild illness in healthy adults, can lead to serious infections in infants and seniors.
Analysts and executives say that uptake of the RSV vaccines for older adults from
GSK
(ticker: GSK) and
Pfizer
(PFE) has so far been strong, despite a lukewarm recommendation from the influential vaccines advisory committee of the Centers for Disease Control and Prevention.
The CDC said Monday, however, that supplies of another new shot that prevents RSV in infants are very limited, and recommends that doctors ration available doses and only use them for infants at highest risk from RSV infection. The shot, called Beyfortus, was developed by
Sanofi
(SNY) and
AstraZeneca
(AZN), and is sold in the U.S. by Sanofi.
Over the long term, the high demand for RSV prophylactics points to the products developing into substantial blockbusters for these companies. GSK expects sales of its RSV shot Arexvy to peak at more than £3 billion, or $3.6 billion, while Pfizer has said it expects its shot Abrysvo to peak above $2 billion in annual sales.
Investors will learn more next week on how the rollout of the RSV vaccines is going so far, when both Pfizer and GSK report third-quarter earnings—Pfizer on Tuesday and GSK on Wednesday. In a note on Oct. 16, Jefferies analyst Akash Tewari wrote that prescription data showed that Pfizer’s shot has captured about 35% of the market, with GSK’s shot making up the rest.
For now, GSK is looking to expand its approval to allow younger adults to receive the shot. The company said Monday that early results from a new Phase 3 study show the immune responses elicited in adults aged 50 to 59 by the vaccine weren’t worse than those seen in adults aged 60 and above. GSK said it will be the “first company” to hand regulators data on that age group, and that approval could come next year.
“This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD,” GSK’s chief scientific officer, Tony Wood, said in a statement.
The CDC’s vaccines advisors said in June that adults aged 60 and up “may receive” an RSV vaccine, if they and their physician agree it’s right for them. Analysts and investors had expected a more strongly-worded recommendation from the advisory committee. The same advisory committee is meeting Wednesday to consider what additional data it might need to recommend the vaccine for that age group.
Pfizer shares were down 0.6% on Wednesday, while GSK’s American depositary receipt was down 0.1%.
Write to Josh Nathan-Kazis at [email protected]
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