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The new pneumococcal vaccine from Merck.
Courtesy of Merck
The Food and Drug Administration approved on Monday MerckThe vaccine manufacturer's new vaccine is designed to protect adults against pneumococcal bacteria, which can cause serious illness and a lung infection called pneumonia, the drugmaker said.
Merck's vaccine, called Capvaxive, specifically protects against 21 strains of these bacteria and prevents a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It is the first pneumococcal conjugate vaccine specifically developed for adults and is designed to provide more comprehensive protection than vaccines currently on the market, the pharmaceutical company said.
Healthy adults can develop pneumococcal disease, but older patients and those with chronic or immunocompromised conditions are at higher risk for the disease, particularly the more severe or so-called “invasive” form.
Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area around the brain and spinal cord, as well as an infection in the bloodstream called bacteremia.
“If you have chronic lung disease or even asthma, you're at a higher risk of getting pneumococcus and then being hospitalized and losing your job,” said Heather Platt, head of Merck's product development team for the newly approved vaccine, in an interview with CNBC. “These are things that have a real impact on the quality of life of adults and children.”
About 150,000 adults in the U.S. are hospitalized with pneumococcal pneumonia each year, Platt said.. The mortality rate for the more severe form of the disease is highest in adults over 50, Merck said in a press release in December.
Even after FDA approval, the company's single-dose vaccine will not yet reach patients. An advisory panel at the U.S. Centers for Disease Control and Prevention (CDC) will meet on June 27 to discuss who is eligible for the shot.
Platt said Merck will support the committee's decision and is ready to provide the vaccine by late summer.
Merck’s competitive advantage
Some analysts see Capvaxive as a key growth driver for Merck, which is preparing to offset losses from its successful cancer drug Keytruda, which will lose its exclusivity in the U.S. in 2028.
The market for pneumococcal conjugate vaccines is currently worth around $7 billion and could grow to over $10 billion in the next few years, according to a note published in November by analysts at Cantor Fitzgerald.
Merck's newly approved vaccine could increase its competitive advantage in this field, which includes drug manufacturers PfizerMerck currently markets two pneumococcal vaccines, but neither is specifically designed for adults. For example, the company's existing vaccine, Vaxneuvance, is approved in the U.S. for patients as young as 6 weeks of age.
Pfizer's pneumococcal vaccine Prevnar 20 is currently the market leader in adults, but Merck expects its new vaccine to capture the largest market share in adults, Platt said.
“We expect rapid adoption of Capvaxive,” she said, adding that the company was confident the vaccine data would “resonate strongly” with physicians and policymakers.
Merck's pneumococcal vaccine protects against eight strains of bacteria not included in any other approved vaccine against the disease. These eight strains account for about 30% of cases of invasive pneumococcal disease in patients ages 65 and older, according to a Merck press release, citing CDC data from 2018 to 2021.
The 21 strains included in Merck's vaccine are responsible for about 85% of cases of invasive pneumococcal disease in adults ages 65 and older, Merck said, citing CDC data. Meanwhile, Pfizer's Prevnar targets strains that are responsible for only about 51% of cases in that age group, according to the same CDC data.
The FDA's approval is based in part on Merck's late-stage STRIDE-3 trial, which compared the vaccine to Pfizer's Prevnar 20 in adults 18 years of age and older who had not previously received pneumococcal vaccination.
Correction: This story has been updated to reflect that 150,000 adults in the United States are hospitalized with pneumococcal pneumonia each year.
