FDA approves Merck’s vaccine against pneumococcus bacteria - Bio.News

FDA approves Merck’s vaccine against pneumococcus bacteria

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The U.S. Food and Drug Administration (FDA) approved the CAPVAXIVE™ vaccine to protect adults from bacteria that can cause pneumonia and invasive pneumococcal disease (IPD), the vaccine maker Merck said on June 17.

The first pneumococcal disease vaccine specifically designed for adults, CAPVAXIVE™ is a one-dose treatment. It targets 21 serotypes of the pneumococcus bacteria (streptococcus pneumoniae), which cause 84% of cases of IPD in adults over 50, and many of these serotypes also cause pneumonia.

“CAPVAXIVE includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; those serotypes were responsible for approximately 27% of IPD cases in adults 50 years of age and older and approximately 30% in adults 65 years of age and older,” Merck said.

Pneumococcal infections “cause more than 50% of all cases of bacterial meningitis in the United States with approximately 2,000 cases of pneumococcal meningitis occurring each year,” according to the Centers for Disease Control and Prevention (CDC). “Over 150,000 hospitalizations from pneumococcal pneumonia are estimated to occur annually in the United States and it has been demonstrated to complicate influenza infection.”

Other conditions caused by pneumococcal infections include osteomyelitis, bacteremia without focus of infection, pneumonia with bacteremia, and septic arthritis, according to the CDC.

Awaiting recommendation for adults

Creating a vaccine specifically for adults is important because the roughly 100 different types of pneumococcal bacteria impact adults and children differently, research has shown. The older cohort needs to be particularly careful about infection.

“The risk of pneumococcal disease was high among older adults and adults with certain risk conditions, particularly immunocompromising conditions,” a recent study confirmed.

Although the vaccine received FDA approval, it won’t be recommended for use until the CDC weighs in. The CDC’s  Advisory Committee on Immunization Practices (ACIP), which routinely gives strong consideration to FDA approval, is scheduled to meet on June 27 to discuss their recommendations for the vaccine.

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