The Food and Drug Administration on Monday approved MerckThe recent vaccine is meant to guard adults from a bacterium known reminiscent of pneumococci, which may cause serious illness and a lung infection called pneumonia, the drugmaker said.
Merck’s shot, called Capvaxivspecifically protects against 21 strains of those bacteria and thus prevents a severe type of Pneumococcal disease which may spread to other parts of the body and result in pneumonia. It is the primary pneumococcal conjugate vaccine specifically developed for adults and is designed to supply broader protection than the available recordings in the marketplace, in accordance with the drug manufacturer.
Healthy adults can develop pneumococcal disease, but older patients and people with chronic or immunocompromised conditions are at higher risk for the disease, particularly the more severe or so-called “invasive” form.
Invasive pneumococcal disease can result in meningitis, an infection that causes inflammation in the realm across the brain and spinal cord, in addition to an infection within the bloodstream called bacteremia.
“If you have chronic lung disease or even asthma, you're at a higher risk of getting pneumococcus and then being hospitalized and losing your job,” said Heather Platt, head of Merck's product development team for the newly approved vaccine, in an interview with CNBC. “These are things that have a real impact on the quality of life of adults and children.”
About 150,000 adults within the U.S. are hospitalized with pneumococcal pneumonia annually, Platt said.. The mortality rate for the more severe type of the disease is highest in adults over 50, Merck said in a release In December.
Even after FDA approval, the corporate's single-dose vaccine won’t yet reach patients. An advisory panel of the Centers for Disease Control and Prevention will meet on June 27 to debate who must be eligible for the vaccination.
Platt said Merck will support the committee's decision and is prepared to supply the vaccine by late summer.
Merck’s competitive advantage
Some analysts see Capvaxive as a key growth driver for Merck, which is preparing to offset losses from its successful cancer drug Keytruda, which is able to lose its exclusivity within the U.S. in 2028.
The marketplace for pneumococcal conjugate vaccines is currently value around $7 billion and will grow to over $10 billion in the following few years, in accordance with a note published in November by analysts at Cantor Fitzgerald.
Merck's newly approved vaccine could increase its competitive advantage on this field, which incorporates drug manufacturers PfizerMerck currently markets two Pneumococcal vaccinationsbut neither is specifically designed for adults. For example, the prevailing vaccine from Vaxneuvance approved within the USA for patients aged 6 weeks and older.
Pfizer's pneumococcal vaccine Prevnar 20 is currently the market leader in adults, but Merck expects its recent vaccine to capture the biggest market share in adults, Platt said.
“We expect rapid adoption of Capvaxive,” she said, adding that the corporate was confident the vaccine data would “really resonate” with doctors and policymakers.
Merck's pneumococcal vaccine protects against eight strains of bacteria not included in some other approved vaccine against the disease. These eight strains account for about 30% of cases of invasive pneumococcal disease in patients ages 65 and older, in accordance with a Merck press release, citing CDC data from 2018 to 2021.
The 21 strains included in Merck's vaccine are liable for about 85% of cases of invasive pneumococcal disease in adults ages 65 and older, Merck said, citing CDC data. Meanwhile, Pfizer's Prevnar targets strains which might be liable for only about 51% of cases in that age group, in accordance with the identical CDC data.
The FDA's approval is predicated partially on Merck's late-stage STRIDE-3 trial, which compared the vaccine to Pfizer's Prevnar 20 in adults 18 years of age and older who had not previously received pneumococcal vaccination.
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