An advisory committee to the U.S. Centers for Disease Control and Prevention recommended Wednesday lowering the age limit for routine pneumococcal vaccination from 65 to 50 to increase the availability of multiple-dose shots on the market or in development.
Committee members voted almost unanimously in favor of the change, which officials said in a statement would allow for greater protection “at an age when the risk of infection is significantly increased.” Previous guidelines recommended vaccination for adults 65 and older, people with certain chronic health conditions, and children under 5. Adults 65 and older and young children are most at risk of infection, according to the CDC.
The new recommendations could grow a lucrative vaccine market long dominated by Pfizer’s Prevnar franchise but now joined by new entrants aiming to offer broader protection.
Merck, for example, received approval from U.S. regulators in June to begin selling capvaxib. This vaccine protects against 21 types of bacteria that cause pneumococcal disease, including 8 types not covered by other vaccines. Merck said these eight cases account for more than a quarter of all invasive pneumococcal disease cases in adults 50 and older.
Behind Merck is Vaxcyte, which is developing a shot designed to cover 31 stocks. Vaxcyte showed positive results in an initial trial in September, with Phase 3 data possible in 2026. GSK is also among the candidates, with the acquisition of start-up Affinivax in 2022.
Jefferies analyst Akash Tewari said in a note to investors that the committee believes that increased vaccination coverage among people currently at risk for poor health conditions may reduce the incidence of the disease. He wrote that he made the decision based on the expectation that there would be no such thing. Nevertheless, Roger Song, also at Jefferies, said in a separate report that the recommendation was “surprising” given the higher costs and the potential need for additional vaccinations at older ages. He said that.
As a result, analysts revised their pneumococcal vaccine sales forecasts. Tewari raised his peak annual sales forecast for Capvaxiv to $1.8 billion from $1.5 billion, and now expects Prevnar 20’s annual sales to reach $7.2 billion, up from $6.8 billion previously.
Leerink Partners analyst Dina Graybosch said the new recommendations could add $700 million to U.S. revenue in fiscal 2026, and Merck expects to see a “big deal” in the adult-use market in the near future. He added that he expects to win a “portion”.
“However, Merck’s advantage will likely be short-lived,” he cautioned, as Vaxcyte’s candidate, if approved, could become a “formidable competitor” by 2028.
