Merck's new pneumococcal vaccine.
Courtesy: Merck
The Food and Drug Administration on Monday approved merckThe new vaccine is designed to protect adults from a bacteria known as pneumococcus that can cause serious illness and a lung infection called pneumonia, a spokesperson for the drugmaker said.
Merck's vaccine, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and cause pneumonia. It is the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than commercially available injections, according to the drugmaker.
Healthy adults can get pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at higher risk of contracting the disease, especially the more severe or so-called “invasive” form.
Invasive pneumococcal disease can cause meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia.
“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease and then being in the hospital, losing your job,” Heather Platt, Merck's product development team leader for the vaccine, said recently. approved. she told CNBC in an interview. “Those are things that have a real impact on adults and children, on their quality of life.”
About 150,000 American adults are hospitalized with invasive pneumococcal disease each year, Platt said. Death from the most severe form of the disease is highest among adults aged 50 and older, Merck said in a December statement.
Even after FDA approval, the company's single-dose vaccine won't reach patients yet. An advisory panel from the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible to receive the vaccine.
Platt said Merck will support the committee's decision and is ready to supply the vaccine by the end of summer.
Merck's competitive advantage
Some analysts see Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose US exclusivity in 2028.
The pneumococcal conjugate vaccine market is currently around $7 billion and could grow to be worth more than $10 billion in the coming years, according to a November note from Cantor Fitzgerald analysts.
Merck's newly approved shot could increase its competitive advantage in that space, which includes drugmakers. Pfizer. Merck currently markets two pneumococcal vaccines, but neither is designed specifically for adults. For example, the company's existing Vaxneuvance vaccine is approved in the US for patients 6 weeks of age and older.
Pfizer's single-dose pneumococcal vaccine, Prevnar 20, is the currently recommended product for adults. But Merck expects its new vaccine to capture most of the market share among adults, Platt said.
“We hope there will be rapid adoption” of Capvaxive, he said, adding that the company is confident the data on the shot will “really resonate” with doctors and policymakers.
Merck's pneumococcal vaccine protects against eight strains of bacteria that are not included in any other approved vaccine for the disease. Those eight strains account for about 30% of cases of invasive pneumococcal disease in patients 65 years old, according to a statement from Merck, citing CDC data from 2018 to 2021.
The 21 strains included in Merck's vaccine account for about 85% of cases of invasive pneumococcal disease in adults age 65 and older, Merck said, citing CDC data. Pfizer's Prevnar, meanwhile, targets strains that only account for about 52% of cases, according to the same CDC data.
The FDA approval is based in part on Merck's late-stage trial called STRIDE-3 that compared the vaccine to Pfizer's Prevnar 20 in adults ages 18 and older who had not previously received a pneumococcal vaccine.
