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Merck Wins FDA Nod over Capvaxive

The U.S. Food and Drug Administration on Monday approved Merck’s (NYSE:MRK) new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, 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 lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.
Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form.

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

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

MRK shares lost 26 cents to $127.24.