The FDA approves Merck's pneumococcal vaccine, intended for adults

Merck's new pneumococcal vaccine.

Courtesy: Merck

The Food and Drug Administration announced this on Monday approved Merck's new vaccine designed to protect adults against a well-known bacterium such as pneumococci can cause severe disease and a lung infection called pneumonia, the drugmaker said.

Merck's shot, called Capvaxiefspecifically protects against 21 strains of that bacteria to prevent a severe form of it pneumococcal disease which 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 the available recordings on the market, according to the drug manufacturer.

Healthy adults can develop pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the disease, especially 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, and an infection in the bloodstream called bacteremia.

“If you have a chronic lung disease, even asthma, you are at greater risk of becoming ill with pneumococcal disease, and then being in the hospital and losing work,” said Heather Platt, head of Merck's product development team for the recently approved vaccine. told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

About 150,000 American adults are hospitalized with invasive pneumococcal disease each year, Platt said. Death from the more severe form of the disease is highest among adults aged 50 and older, Merck said in an article Edition in December.

Even after FDA approval, the company's single-dose vaccine won't reach patients. An advisory panel from the Centers for Disease Control and Prevention will do that Meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee's decision and is ready to deliver the vaccine by the end of the summer.

Merck's competitive advantage

Some analysts see Capvaxive as a key growth driver for Merck as the company prepares to offset losses from its hit cancer drug Keytruda, which is set to lose out to rivals. exclusivity in the US in 2028.

The market for pneumococcal conjugate vaccines is currently about $7 billion and could grow to more than $10 billion in the coming years, according to a November note from Cantor Fitzgerald analysts.

Merck's recently approved shot could boost its competitive advantage in that area, including the pharmaceutical industry Pfizer. Merck currently markets two of them pneumococcal injections, but neither is specifically designed for adults. For example, the company's existing shot is Vaxneuvance approved in the US for patients 6 weeks and older.

Pfizer's single-dose pneumococcal vaccine, Prevnar 20, is currently the recommended product for adults. But Merck expects its new effort to capture the largest market share among adults, Platt said.

“We expect Capvaxive to be adopted quickly,” she 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 not found in any other approved shot for the disease. These eight strains are responsible for about 30% of cases of invasive pneumococcal disease in patients 65, according to a Merck press release, citing CDC data from 2018 to 2021.

The 21 strains in Merck's shot are responsible for about 85% of cases of invasive pneumococcal disease in adults aged 65 and older, Merck said, citing the CDC data. Meanwhile, Pfizer's Prevnar focuses on strains that represent only about 52% of cases, based on the same CDC data.

The FDA approval is based in part on Merck's late-stage study called STRIDE-3, which pitted the vaccine against Pfizer's Prevnar 20 in adults 18 years and older who had not previously received a pneumococcal vaccine.

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