Streptococcal Infections

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. '

A panel of advisers to the Centers for Disease Control and Prevention on Wednesday recommended lowering the age for routine pneumococcal vaccination from 65 to 50 years of age, boosting the sales potential for multiple shots on the market or in development.Committee members voted nearly unanimously to make the change, with the agency noting in a statement that it will allow for greater protection at the age when risk of infection substantially increases.Previous guidelines endorsed shots for adults at least 65 years of age, people with certain chronic health conditions, and kids under 5. Adults over the age of 65 and young children are at the highest risk of infection, according to the CDC.The new recommendation could grow a lucrative market for vaccines thats long been dominated by Pfizers Prevnar franchise, but now includes additional and emerging entrants designed to provide broader protection.Merck, for instance,was cleared by U.S. regulators in June to begin selling Capvaxive. That shot protects against 21 types of the bacteria that cause pneumococcal disease,including eight not covered by other vaccines. Merck has said those eight account for more than one-quarter of invasive pneumococcal disease cases in adults 50 years and older.Behind Merck is Vaxcyte, which is developing a shot designed to cover 31 strains. Vaxcyteproduced positive results in a early trialin September and could have Phase 3 data in 2026. GSK is in the mix as well, with a candidate it acquired in a buyout of startup Affinivax in 2022.The panel made its decision based on the hope that it might boost uptake of the shots and reduce the incidence of disease in people currently at risk of poor health outcomes, wrote Jefferies analyst Akash Tewari in a note to investors. Nonetheless, in a separate report, Roger Song, also of Jefferies, called the recommendation a surprise, given it could raise costs and mean people will require an additional shot as they get older.Analysts, as a result, have revised their sales estimates for pneumococcal shots. Tewari boosted peak annual sales projections for Capvaxive from $1.5 billion to $1.8 billion and now expects Prevnar 20 to bring in as much as $7.2 billion annually, from $6.8 billion previously.Leerink Partners analyst Daina Graybosch added that she expects Merck to get the lions share of the adult market in the near term, with the new recommendation leading to a possible $700 million boost in U.S. revenue in the 2026 fiscal year.Mercks dominance will likely be short-lived, however, she cautioned, as Vaxcytes candidate, if approved, could be a formidable competitor by 2028. '

The CDC AdCom recommended for pneumococcal vaccination in all adults older than 50 years and in 19–49 year olds with certain underlying conditions, risk factors and vaccination history. Image credit: Tada Images / Shutterstock. A US Centers for Disease Control and Prevention’s (CDC) Advisory Committee (AdCom) on Immunization Practice (ACIP) voted in favour of lowering the recommended age for pneumococcal vaccines to 50 years, down from 65. The recommendation, backed by CDC director Mandy Cohen, affects approved pneumococcal vaccines such as MSD (Merck & Co)’s Capvaxive and Pfizer’s Prevnar 20. Currently, the CDC recommends pneumococcal vaccination for adults aged 65 years and older, as well as in young adults aged 19 through 65 with certain risk conditions. Prevnar 20 (20-valent pneumococcal conjugate vaccine/PCV20) was approved by the US Food and Drug Administration (FDA) for adults over 18 years of age in 2021. Two years later, the agency expanded the vaccine label to include infants and children, between six weeks and 17 years of age. Prevnar generated $6.4bn in sales last year, according to Pfizer’s financials. GlobalData expects the vaccine to continue to maintain comparable sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology . MSD’s Capvaxive (21-valent pneumococcal conjugate vaccine/PCV21) gained received an FDA accelerated approval in June . The vaccine is indicated for prevention of pneumonia caused by 22 serotypes of S. pneumoniae based on immune responses as measured by opsonophagocytic activity (OPA). See Also: Alpha-9 becomes latest radiopharma to secure funds with $175m Series C Pharmacists “desperation” by Novo Nordisk over semaglutide copycat block Although the AdCom voted in favour of lowering the recommended age for vaccination, a few experts were against including PCV20 in the update noting that the newer PCV21 was more cost effective. Pfizer’s PCV20 vaccine is priced at $262/dose compared to MSD’s PCV21 valued at $287/dose, according to the pricing model presented at the CDC AdCom meeting. MSD was quick to note that Capvaxive “covers the serotypes responsible for approximately 84% of invasive pneumococcal disease (IPD) cases, compared to approximately 52% covered by PCV20, based on CDC epidemiologic data”. Whilst Pfizer highlighted that Prevnar 20, unlike Capvaxive, helps prevent serotype 4 disease, an emergent strain of S. pneumoniae that has been responsible for causing IPD in certain parts of the US. The AdCom recommendations are not binding and will only be official after being reviewed and finalised by the director of the CDC and the Department of Health and Human Services.