Merck’s new pneumococcal vaccine.
Courtesy: Merck
Food and Drug Administration approved Monday MerckNew vaccine designed to protect adults from infection a known bacterium As a pneumococcus, it can cause serious illness A spokesman for the drugmaker said there is also a lung infection called pneumonia.
Merck’s shot, known as capasivirwhich specifically protects against 21 strains of this bacteria to prevent severe forms of infection pneumococcal disease It can spread to other parts of the body and cause pneumonia. This is the first pneumococcal conjugate vaccine designed specifically for adults and is designed to provide broader protection than the common pneumococcal vaccine. Available lenses on the market, according to the drugmaker.
Healthy adults can develop pneumococcal disease. But older patients and those with chronic or immunocompromised health conditions are at increased risk for the disease, especially more severe or so-called “invasive” forms.
Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation of the area around the brain and spinal cord, and a blood infection called bacteremia.
“If you have chronic lung disease or even asthma, you’re at a higher risk of developing pneumococcal disease and being hospitalized,” said Heather Platt, head of the product development team for the newly approved vaccine at Merck. , job losses. “These are things that have a real impact on adults and children and their quality of life. “
About 150,000 U.S. adults are hospitalized with invasive pneumococcal disease each year, Platt said. The highest number of deaths from the more severe disease is among adults aged 50 and older, Merck said in a report. release in December.
Even after receiving FDA approval, the company’s single-dose vaccine has yet to reach patients. A Centers for Disease Control and Prevention advisory panel will Meet June 27 to discuss who should be eligible for the shot.
Platt said Merck would support the committee’s decision and be ready to supply a vaccine by the end of summer.
Merck’s Competitive Advantages
Some analysts see Capvaxive as a key growth driver for Merck as the company prepares to offset losses on its blockbuster cancer drug Keytruda, which will lose Exclusive rights to operate in the U.S. in 2028.
A November report from analysts at Cantor Fitzgerald said the market for pneumococcal conjugate vaccines, currently about $7 billion, could grow to more than $10 billion in the next few years.
Merck’s newly approved vaccine could bolster its competitive advantage in the field, including among drugmakers Pfizer. Merck currently sells two pneumococcal vaccine, but neither is designed specifically for adults. For example, the company’s existing lens Vaxneuvance is officially recognized In the United States, for patients 6 weeks of age and older.
Pfizer’s single-dose pneumococcal vaccine Prevnar 20 is currently recommended for use in adults. But Platt said Merck expects its new vaccine to capture a majority of the adult market.
“We do anticipate rapid adoption of Capvaxive,” she said, adding that the company believes the data on the shot will “really resonate with clinicians and policymakers.”
Merck’s pneumococcal vaccine protects against eight bacterial strains that are not included in any other approved pneumococcal vaccine. According to a press release from Merck, citing CDC data from 2018 to 2021, these eight strains accounted for approximately 65% of invasive pneumococcal disease cases in patients.
The 21 strains Merck injected account for about 85% of cases of invasive pneumococcal disease in adults 65 years and older, citing CDC data. Meanwhile, the strain targeted by Pfizer’s Prevnar accounts for only about 52% of cases, according to the same CDC data.
The FDA’s approval was based in part on Merck’s late-stage trial called STRIDE-3, which compared the vaccine to Pfizer’s Prevnar 20 in adults 18 and older who had not previously received a pneumococcal vaccine.
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