Tuesday, November 2, 2021

Pfizer’s pneumococcal disease vaccine scores FDA priority review

The US Food and Drug Administration (FDA) has granted Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate a priority review for the prevention of pneumococcal disease.

Pfizer is eyeing approval for the vaccine candidate as a preventative shot against invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.

The FDA has already handed Pfizer a fast track designation for 20vPnC to potentially be used in adults aged 18 years and older for the prevention of invasive pneumococcal disease, as well as a breakthrough therapy designation.

The 20vPnC vaccine candidate comprises capsular polysaccharide conjugates for the 13 serotypes already included in Pfizer’s Prevnar 13, as well as capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD).

The seven additional serotypes have been associated with high case-fatality rates, antibiotic resistance and/or meningitis, Pfizer added in a statement.

Pneumococcal pneumonia causes approximately 500,000 deaths and 30 million episodes in adults aged 70 years and older each year globally.

“The FDA’s acceptance of our application for 20vPnC is yet another significant milestone in Pfizer’s continuing efforts to help protect adults against pneumococcal disease,” said Kathrin Jansen, senior vice president and head of vaccine research and development, Pfizer.

“If approved, 20vPnC will cover more serotypes responsible for the majority of pneumococcal disease than any other pneumococcal conjugate vaccine currently licensed or currently in late-stage clinical development. Importantly, 20vPnC has shown to induce immune memory, which provides protection and efficacy against non-bacteremic pneumonia, particularly in older adults,” she added.

Following the acceptance of the priority review for Pfizer’s 20vPnC, the FDA has set a goal date for a decision on the vaccine candidate in June 2021.

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