FDA approves Merck pneumococcal disease vaccine designed for adults

FDA approves Merck pneumococcal disease vaccine designed for adults

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The new pneumococcal vaccine from Merck.

Courtesy: Merck

The Food and Drug Administration gave approval Monday MerckThe new vaccine is designed to protect adults against a bacteria called pneumococcus, which can cause serious illness and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of these bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. According to the drug manufacturer, it is the first pneumococcal conjugate vaccine developed specifically for adults and is intended to provide more comprehensive protection than vaccinations available on the market.

Healthy adults can suffer from pneumococcal disease. However, older patients and patients with chronic or immunocompromised diseases are at increased risk of the disease, especially the more serious or so-called “invasive” form.

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation around the brain and spinal cord, and an infection of the bloodstream called bacteremia.

“If you have chronic lung disease, even asthma, you have a higher risk of getting pneumococcal disease, then being in the hospital and losing your job,” said Heather Platt, head of Merck’s product development team for the new approved vaccine. said CNBC in an interview. “These are things that have a real impact on the quality of life for adults and children.”

According to Platt, approximately 150,000 adults in the United States are hospitalized with invasive pneumococcal disease each year. Death from the more serious form of the disease is highest among adults 50 and older, Merck said in a news release in December.

Even after FDA approval, the company’s single-dose vaccine still won’t reach patients. A Centers for Disease Control and Prevention advisory panel will meet June 27 to discuss who should be eligible for the vaccine.

Platt said Merck will support the committee’s decision and is ready to deliver the vaccine by late summer.

Merck’s competitive advantage

Some analysts view Capvaxive as a key growth driver for Merck as the company prepares to recoup losses from its blockbuster cancer drug Keytruda, which will lose its exclusivity in the U.S. in 2028.

The pneumococcal conjugate vaccine market is currently worth about $7 billion and could grow to more than $10 billion in the next few years, according to a November note from analysts at Cantor Fitzgerald.

Merck’s newly approved vaccine could strengthen its competitive edge in this space, which includes the drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed 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 expect Capvaxive to be adopted quickly,” she said, adding that the company is confident the vaccination data will “really resonate” with doctors and policymakers.

Merck’s pneumococcal vaccine protects against eight strains of bacteria that are not found in any other approved vaccination against the disease. These eight strains account for about 30% of cases of invasive pneumococcal disease in patients 65, Merck said in a news release, 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 65 and older, Merck said, citing CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for about 52% of cases, according to the same CDC data.

The FDA’s approval is based in part on Merck’s late-stage trial called STRIDE-3, which tested Pfizer’s Prevnar 20 vaccine in adults 18 and older who had not previously received a pneumococcal vaccine.

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2024-06-17 21:48:26