FDA Authorizes Merck Vaccine for Adults Against Pneumonia-Causing Bacteria

On Monday, Merck announced that the Food and Drug Administration (FDA) has given the green light to its new vaccine aimed to protect adults from pneumococcus, a bacteria, which can lead to severe illnesses including pneumonia.

According to CDC data, the new vaccine, CAPVAXIVE, is made specifically for adults and protects against strains that cause around 85% of major pneumococcal infections in adults aged 65 and over. In contrast, Pfizer’s Prevnar targets strains responsible for approximately 51% of cases in the same age group, also based on CDC data.

Analysts at Cantor Fitzgerald predict that the pneumococcal conjugate vaccine market, which is currently worth about $7 billion, could grow to over $10 billion in the next few years.

With its new vaccine approved, Merck could gain a competitive edge over rivals such as Pfizer in this growing market. Although Merck already has two pneumococcal vaccines, neither is specifically designed for adults. For instance, Vaxneuvance is approved in the U.S. for people as young as 6 weeks old.

Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University and a member of Merck’s Scientific Advisory Committee, said, “Complications from invasive pneumococcal disease can lead to hospitalization, organ damage and even death. Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines.”

He added, “CAPVAXIVE is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”

CAPVAXIVE’s authorization by the FDA is supported by four phase 3 trials, incorporating a comparative study with Prevnar 20 on immune responses. The research demonstrated V116’s inferiority in the 10 shared serotypes and its superiority in 10 out of its 11 distinct serotypes.

Before approval, Heather Platt, M.D., Merck’s pneumococcal vaccine lead, said in an interview with Fierce Pharma, “We have eight serotypes in V116 that are not in any currently licensed vaccine. Those eight serotypes are responsible for 30% of invasive pneumococcal disease in adults 65 years of age and older,”

Merck has emerged as a pioneer in developing a vaccine for pneumococcus in adults, positioning itself in a stronger position as other companies working on similar adult vaccines follow behind in the race.

A strong competitor in this space is Vaxcyte, a biotech company based in California. It is working on a 24-valent vaccine for adults that covers all the serotypes in Prevnar 20, along with four additional strains. In a phase 2 trial, Vaxcyte’s vaccine showed promising results compared to Pfizer’s leading product. Vaxcyte also has a 31-valent pneumococcal vaccine in development specifically aimed at children.

Platt stated that the company does “expect there to be rapid uptake of” the new vaccine. She expressed confidence that the data on the new vaccine will strongly resonate with both clinicians and policymakers.