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Sales of Pfizers new vaccine for respiratory syncytial virus were lower in the third quarter than during the same period last year, but the company pointed to signs of growing market share as reason for confidence in the shots market potential.Between July and September, Abrysvo brought Pfizer $356 million in sales globally, compared to last years total of $375 million, according to third quarter earnings Pfizer reported Tuesday. Revenue across the first nine months was higher, reaching $557 million versus the $375 million last year, because Abrysvo wasnt approved in the U.S. for older adults until the end of May last year.So far, Pfizer has trailed competitor GSK, which has been able to dominate the nascent RSV vaccine market with its shot Arexvy, despite it only winning approval weeks earlier.However, Pfizer said Abrysvos market share has increased, exceeding 50% of shipped volume for the third quarter. Abrysvos slice of vaccinations in the retail setting has also climbed for nine consecutive weeks through mid-October, currently reaching 43%, Pfizer CEO Albert Bourla said in prepared remarks.Both companies are working to expand the number of people eligible for vaccination. Last week, the Food and Drug Administration cleared Abrysvo for use in certain adults aged 18 years to 59 years old who are at higher risk of RSV-related disease. Previously it only had been available for adults 60 years or older, or for pregnant women.On a conference call Tuesday, Pfizers commercial chief Aamir Malik said the company is seeing really good momentum in maternal vaccination. Over the first four weeks of the season, Malik said, Pfizer shipped 56% more units of Abrysvo to obstetricians and gynecologists in health systems than during the same period last year.However, uptake among older adults has been disrupted somewhat by recommendations provided this summer by the Centers for Disease Control and Prevention. The agency narrowed its guidance to urge vaccination most heavily in adults over 75 years old and in those aged 60 to 74 years who are at higher risk.Company executives said the updated guidelines have affected uptake. [Abrysvo vaccinations] are at lower volumes, from a market perspective, than where they were last year,“ said Malik, on Tuesdays call. Malik cited the CDCs recommendation, as well as the timing of COVID vaccination this year.CDC advisers, who have since met again following that recommendation, also havent endorsed expanding their recommendations to adults younger than 60, or recommending previously vaccinated individuals to get another shot.Mikael Dolsten, Pfizers departing chief scientific officer, said Tuesday the company is accumulating evidence on revaccination and suggested that an additional dose might be appropriate after several years.Beyond RSV, Pfizer also talked up its next-generation pneumococcal vaccines that it eventually hopes will replace its top-selling Prevnar 20. One, which covers 25 serotypes of the bacteria that causes disease, is in Phase 2 testing. Another, covering more than 30 serotypes, is in preclinical development.Both shots would provide additional coverage against pneumococcal disease, but Pfizer has competitors. Merck & Co. recently won approval of a 21-valent shot called Capvaxive, while biotechnology company Vaxcyte impressed with early trial data on a rival product. In a note to clients, analysts at Jefferies said Pfizers 25-valent shot might have difficulty competing. '

Exterior view of the headquarters of the Centers for Disease Control and Prevention in Atlanta, Georgia iStock, hapabapa The CDC’s vaccine advisors on Thursday maintained that respiratory syncytial virus immunization is only recommended for adults aged 75 and older, and in seniors 60 to 74 years who are at risk of severe disease. On Thursday, a panel of advisors to the U.S. Centers for Disease Control and Prevention declined to endorse respiratory syncytial virus vaccines for younger adults, insisting that current guidelines are “appropriate.” The CDC’s Advisory Committee on Immunization Practices (ACIP) affirmed that respiratory syncytial virus (RSV) shots should only be recommended for adults 75 years and older, and seniors 60 to 74 years who are at risk of severe disease. The committee’s RSV working group determined that for these populations “the benefits of RSV vaccination outweigh risks.” For those aged 60 and younger, the ACIP maintains that existing data have not “motivated an immediate policy expansion.” Recent evidence provide “increasing certainty” that a specific component of the RSV vaccines is associated with the risk of Guillain–Barré syndrome, a rare but severe side effect where the immune system attacks peripheral nerves, according to the panel. This safety signal muddies the benefit-risk calculation for younger adults, in whom the risk of severe RSV disease is generally lower than in seniors, the committee contends. The ACIP said it “continues to evaluate recommendations” for RSV vaccination. “Developing RSV vaccine policy in adults <60 years will require careful consideration of the balance of public health benefits and risks in this population,” the advisers wrote in Thursday’s presentation. In maintaining these age restrictions, the ACIP delt a blow to GSK, Moderna and and Pfizer. In an October 2024 report, analytics company Airfinity projected that these limitations could cut RSV annual revenues to just $1.7 billion by 2030—a 64% reduction from a prior estimate of $4.6 billion. GSK’s Arexvy—which became the industry’s first FDA-approved RSV shot in May 2023 —was greenlit for use in adults aged 50 to 59 in June 2024 . On Thursday, GSK unveiled Phase IIIb data showing that a single dose of Arexvy could elicit a “robust immune response” in adults aged 18 to 49 years, with an acceptable safety profile. CSO Tony Wood said that these findings suggest that Arexvy “could help expand protection to more adults at risk from RSV disease.” Pfizer’s Abrysvo, which was also originally approved for adults aged 60 and older, won regulatory go-ahead for a younger adult population earlier this week , allowing its use in adults 18 through 59 years who are at increased risk of RSV disease. Moderna’s mResvia is a relative newcomer to the RSV market, winning the FDA’s approval in May 2024 . The mRNA shot is indicated for adults aged 60 and older. GSK is the current RSV market leader. In December 2023, CEO Emma Walmsley said in an investor event that Arexvy was on-track to blockbuster status, having captured most of retail vaccinations in the U.S. Pfizer’s Abrysvo, meanwhile, has largely had a disappointing market showing, CFO David Denton said in a November 2023 conference, as reported by Reuters . By the end of 2023, Arexvy had brought in nearly $1.6 billion , while Abrysvo’s sales sat at $515 million.