GSK, Pfizer and Moderna are set to see a combined drop in US sales of their RSV vaccine for adults by nearly a third after health panels narrowed recommendations on the vaccine's use, according to new forecasts.
A Centers for Disease Control and Prevention committee has found that the market for respiratory syncytial virus infections among older adults could shrink from $4.7 billion annually to $1.7 billion by 2030, according to a new analysis by data provider Airfinity. Limited support They recommended that older patients and those most at risk not get the vaccine, and chose not to recommend a booster shot for adults.
GSK, Pfizer and Moderna have all recently vaccine It is a cold-like illness that often occurs in winter, and is particularly prevalent among the elderly and young children.
The CDC's Advisory Committee on Immunization Practices in June recommended routine vaccination for people aged 75 and older and those aged 60 to 74 who are at high risk of severe RSV disease, instead of previous guidance that all adults 60 and older should be able to get the vaccine after a doctor's decision. The committee also postponed a decision on whether to expand vaccination to at-risk people aged 50 to 59.
While the CDC's recommendation may be revised as more data on the vaccine becomes available, Airfinity expects RSV vaccine sales to older Americans to fall to $2.2 billion in 2024 from a projected $3.7 billion, according to data provided to the Financial Times.
The recommendation “is likely to hinder revenue growth in the U.S. market unless supported by new data.” [the case for] “We need a booster shot,” said Isabella Huettner, lead RSV market analyst at Airfinity.
GSK's Alexi was the world's first approved RSV vaccine, backed by the U.S. Food and Drug Administration for 2023, just before Pfizer's Avrisvo treatment, which can be given to pregnant women. Infants can receive Bayfortas, an antibody treatment developed by AstraZeneca and Sanofi.
Analysts consider Alexi's U.S. rollout a success. The company quickly captured two-thirds of RSV vaccine sales in the U.S. and achieved blockbuster status, raking in more than $1 billion in revenue within nine months. The company projects Alexi's annual sales to peak at more than $3 billion.
GSK had been betting that use of its vaccine would be expanded to at-risk people over 50 to boost sales, but Airfinity said the ACIP delay had cost it about $300 million in lost revenue this year.GSK, which reports second-quarter results next week, declined to comment on the figures.
The ACIP said more data was needed before recommending wider use of the vaccine after a small number of clinical trial participants developed Guillain-Barré syndrome, a rare disease that affects the immune system.
The ACIP decision in June surprised markets, causing GSK shares to fall 6 percent. The RSV vaccine was Moderna's second approved product. The biotech's shares fell after data showed the protective efficacy of its recently approved mRNA-based vaccine declined more quickly than competing vaccines from GSK and Pfizer.
Citi analyst Peter Berdault said the decision was a “blow” to Pfizer and GSK, noting that the ACIP's decision was “driven primarily by cost-effectiveness.” Alexi has a list price of $280 a dose and Avrisvo $295.
If manufacturers lowered their list prices, RSV vaccines would be considered more cost-effective, he added.
Both companies are expected to see further growth as overseas sales pick up with the launch of their RSV vaccines in Europe and Canada. But GSK suffered a further setback in June after the UK decided to use Pfizer's Avrisvo vaccine for pregnant women and people over 75 in its vaccine rollout this winter.
Airfinity's previous estimate of $4.7 billion in annual sales was based on annual booster vaccinations. If biennial boosters were recommended, annual RSV vaccine sales could reach $6.6 billion by 2030.
GSK said: “We have an extensive development plan for Alexi and continue to see this potential vaccine as a significant long-term growth opportunity for GSK.”
Pfizer said the company “remains well-positioned in this competitive marketplace.” The New York-based drugmaker said the CDC's ACIP's decision “underscores the importance of protecting adults 60 years and older who are at high risk for severe RSV infection.” Moderna declined to comment.
