Dive Brief:
- Merck said Thursday its experimental pneumococcal disease vaccine succeeded in two late-stage studies of adults, findings that may help the company take on market leader Pfizer.
- The trials tested Merck’s V116, a vaccine designed to fight 21 strains of the potentially deadly pneumococcal bacteria. Eight of those strains are unique to V116 and are responsible for about 30% of invasive pneumococcal disease in seniors, according to the drugmaker.
- In one study, researchers tested adults getting a vaccine for the first time and found that V116 elicited significant immune responses compared with Pfizer’s Prevnar 20 on strains that both shots are designed to fight, Merck said, without giving details. In the other trial, V116 sparked an immune response to all 21 strains in patients who had previously received an inoculation.
Dive Insight:
Merck plans to use the results to seek global regulatory clearance of V116 and attempt to position the vaccine as a more attractive option than Pfizer’s Prevnar 20, which has been available since 2021 and won Food and Drug Administration approval for use in children and infants in April.
The two companies have long battled in the pneumococcal market, with Pfizer having the edge. Sales of Pfizer’s Prevnar franchise reached $1.6 billion in the first quarter. Merck chalked up combined sales of $202 million for its older Pneumovax 23 and newer Vaxneuvance products during the same period.
Vaccination against pneumococcal disease is now commonplace for children, but many adults have never gotten a shot. U.S. health officials are trying to change that, recommending routine vaccination for seniors and for younger adults with risk factors. The disease leads to about 150,000 hospitalizations every year in the U.S. and kills as many as 7% of those infected.
In its statement Thursday, Merck focused on the eight strains covered by V116 that aren’t available in any other vaccine, saying the shot may be “an important new preventative option.” The company was the initial leader in the market, winning FDA approval for Pneumovax 23 in 1983. Pfizer followed with Prevnar 13 in 2010.
The continuing need for better options to fight the disease drove Pfizer to develop Prevnar 20 and Merck to bring Vaxneuvance to market. It’s also drawn the interest of other companies; GSK bought Affinivax last year to acquire a 24-valent vaccine, and the biotech Vaxcyte is also developing a 24-valent option that’s shown promise in early testing.