The new pneumococcal vaccine from Merck.
Courtesy: Merck
The Food and Drug Administration approved Monday MerckThe drugmaker said the new vaccine developed by the company is designed to protect adults from bacteria known as pneumococcus that can cause serious illness and lung infection called pneumonia.
Merck's shot, called Capvaxive, specifically protects against 21 strains of those bacteria to prevent 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 designed specifically for adults and aims to provide broader protection than vaccines available on the market, according to the drug company.
Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic health conditions or weakened immune systems are at increased risk of contracting the disease, especially the more severe or so-called “invasive” form.
Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation of the area surrounding the brain and spinal cord, and an infection of the bloodstream called bacteremia.
“If you have chronic lung disease, even asthma, you're more likely to get pneumococcal disease, stay in the hospital, and lose work,” says Heather Platt, Merck's product development team leader for the newly cleared vaccine. He told CNBC in an interview. “These are things that have a real impact on adults and children and their quality of life.”
About 150,000 American adults are hospitalized with pneumococcal pneumonia each year, Platt said. Deaths from the most severe form of the disease are highest among adults ages 50 and older, Merck said in a statement in December.
Even after approval by the US Food and Drug Administration, the company's single-dose vaccine will not reach patients yet. A Centers for Disease Control and Prevention advisory committee will meet on June 27 to discuss who should be eligible to get the vaccine.
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 view Capvaxiv as a key growth driver for Merck as it prepares to recoup losses from its blockbuster cancer drug Keytruda, which will lose U.S. exclusivity in 2028.
The pneumococcal conjugate vaccine market is currently worth about $7 billion and could grow to be worth more than $10 billion over the next few years, according to a November note from Cantor Fitzgerald analysts.
Merck's newly approved shot could boost its competitiveness in this space, which includes the drugmaker Pfizer. Merck currently markets two pneumococcal doses, but neither is designed specifically for adults. For example, the company's current Vaxneuvance vaccine is approved in the U.S. for patients 6 weeks of age and older.
Pfizer's single-dose pneumococcal vaccine, Prevnar 20, is the current market leader for adults. Platt said Merck expects its new doses to capture the majority of the market share among adults.
“We expect there will be rapid uptake of Capvaxive,” she said, adding that the company is confident that the data on the shot “will really resonate” with doctors and policy makers.
Merck's pneumococcal vaccine protects against eight strains of bacteria not included in any other approved pneumococcal vaccine. These eight strains account for approximately 30% of cases of invasive pneumococcal disease in patients 65 and older, according to a statement from Merck, citing Centers for Disease Control and Prevention data from 2018 to 2021.
The 21 strains included in Merck's shot account for approximately 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 account for only about 51% of cases in that age group, based on the same CDC data.
The FDA approval is based in part on Merck's late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer's Prevnar 20 in adults ages 18 and older who had not previously received the pneumococcal conjugate vaccine.
Correction: This story has been updated to reflect the 150,000 American adults hospitalized with pneumococcal pneumonia each year.
