The European Commission has granted approval for Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, to prevent lower respiratory tract disease caused by RSV in adults aged 18 to 59 who are at increased risk. This approval, which applies to all 27 EU member states, follows the recommendation from the European Medicines Agency’s expert panel in March.
This approval marks a significant milestone for Pfizer, as it expands the use of its vaccine in Europe, potentially boosting sales for the U.S.-based pharmaceutical giant. By contrast, competitor GSK has yet to receive similar approval for its RSV vaccine for this age group.
RSV, a widespread virus, poses a serious health threat, particularly to infants and elderly individuals. Both Pfizer and GSK have positioned their RSV vaccines as key products in their portfolios, aiming to capitalize on the growing demand for preventive treatments. These vaccines were both launched in the U.S. in 2023, with an eye on long-term sales as the companies face increasing competition from generic drugs in the coming years.
However, both companies have faced challenges in achieving significant sales in the U.S. market, particularly during the second autumn vaccination season since their launch. In Europe, Pfizer has seen more success, notably securing a contract with the British government to supply 5 million doses for older adults and pregnant women over the next two years. Data published last week by the UK Health and Security Agency from the 2024 rollout of Pfizer’s vaccine indicated a notable reduction in hospital admissions among older adults.
This positive data could influence other European countries in their decisions to introduce RSV vaccines into national immunization programs.
Currently, Pfizer’s RSV vaccine is part of immunization programs in four EU countries for older adults. A Pfizer spokesperson confirmed the vaccine’s inclusion in these national programs on Tuesday.
In the U.S., shares of both Pfizer and GSK dropped on Monday after reports that the Food and Drug Administration’s top vaccine official had resigned, adding a layer of uncertainty for both companies in the vaccine market.
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