In June, the U.S. Food and Drug Administration (FDA) approved Merck’s (NYSE: MRK) new pneumococcal vaccine, Capvaxive, for adults aged 18 and older. This approval follows the FDA’s Priority Review of Merck’s application. Capvaxive is designed to protect against pneumococcal pneumonia, which affects approximately 150,000 adults in the U.S. annually and has a fatality rate of about 5% according to the National Foundation for Infectious Diseases. Capvaxive is the first vaccine specifically targeting the Streptococcus pneumoniae serotypes that most commonly infect older adults. It provides coverage for 21 different serotypes, including eight not covered by any existing vaccines.
With Capvaxive’s approval, Merck is entering the market to compete with Pfizer’s Prevnar 20, which is currently the leading pneumococcal vaccine. Prevnar 20 was approved in June 2021 for adults to protect against invasive pneumococcal disease (IPD) and pneumonia. In April 2023, the FDA extended its use to include infants and children from six weeks to 17 years of age. Generating $133 million in revenue in 2024, Visible Alpha consensus estimates show blockbuster sales of $1.1 billion for Capvaxive by 2027. Peak sales of $1.32 billion are estimated by 2033, with the patent set to expire on June 17, 2036. Merck’s Capvaxive joins its 15-valent pneumococcal shot Vaxneuvance, which generated $665 million in sales last year and is expected to generate $902 million in 2024. Pfizer’s (NYSE: PFE) Prevnar family of vaccines, meanwhile, pulled in revenue of $6.5 billion in 2023 and is expected to generate $6.4 billion in 2024.