Dive Brief:

• The Food and Drug Administration on Monday approved a new vaccine from Merck & Co. that protects against 21 types of the bacteria that causes pneumococcal disease.
• The vaccine, cleared for use in adults 18 and older, will be sold by Merck as Capvaxive. Pneumococcal disease can lead to severe infection in the lungs or sometimes in the blood and spinal cord, when it is known as meningitis. Adults older than 65 or who have compromised immune systems are at particular risk for the disease.
• Merck expects to make the vaccine available as soon as late July, depending on the recommendations provided by advisers to the Centers for Disease Control and Prevention, who are scheduled to meet later this month.

Dive Insight:

Merck currently sells two pneumococcal vaccines. One, dubbed Pneumovax 23, is for adults at least 50 years of age and children older than two who are increased risk of infection. The other, Vaxneuvance, is for those aged six weeks and older.

But it’s Pfizer’s Prevnar shots that have dominanted the market. The company’s Prevnar 20 gained approval in 2021 for adults 18 years or older and is now also cleared for infants and teenagers. The vaccine protects against 20 serotypes, while Merck’s Vaxneuvance covers 15.

Capvaxive could have an edge there, as it targets 21 serotypes, including eight not covered by other shots.

“[Capvaxive] will be the first approved pneumococcal conjugate vaccine specifically designed to help protect against the serotypes that cause the majority of invasive pneumococcal disease in adults,” wrote Paula Annunziato, vice president of vaccine clinical development at Merck, in an email to BioPharma Dive. “It covers the serotypes responsible for ~84% of cases of [invasive pneumococcal disease] in adults 50 years and older.”

The comparator number for Prevnar 20 is 52%, per Merck. And according to the company, the eight unique serotypes covered by Capvaxive alone account for more than one-quarter of invasive pneumococcal disease cases in adults 50 years and older.

In a note to clients, Cantor Fitzgerald analyst Louise Chen said a preferential recommendation from the Advisory Committee on Immunization Practices, or ACIP, would help boost sales of Merck’s vaccine. The advisory committee is set to meet on June 27.

Merck set the price of Capvaxive at $287 per the single dose used for immunization. In a statement, Merck said most people in the U.S. would have access at no out-of-pocket cost if the CDC panel gives a routine recommendation to Capvaxive.