Prevnar 20 is the first conjugate vaccine approved to protect against 20 types of invasive pneumococcal diseases and pneumonia
Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia.)
Pfizer has received the US Food and Drug Administration (FDA) approval for its Pneumococcal 20-valent conjugate vaccine, Prevnar 20, for use in people aged 18 years and above.
The conjugate vaccine offers prevention against invasive disease and pneumonia caused by 20 serotypes of Streptococcus pneumoniae (pneumococcus) in adults.
The US Centres for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.
Pfizer senior vice president and vaccine research and development head Kathrin U Jansen said: “Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines.
“With a single injection, Prevnar 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”
Prevnar 20 contains capsular polysaccharide conjugates for the 13 serotypes, which are already included in the Pneumococcal 13-valent conjugate vaccine Prevnar 13.
Also, it includes capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD) and linked to high case-fatality rates, antibiotic resistance and meningitis, said the company.
The US regulatory agency approved Prevnar 20 based on evidence from Pfizer’s clinical programme including Phase 1 and 2 trials, and three Phase 3 trials in adults.
The Phase 3 trials evaluated the safety and immunogenicity of the vaccine in more than 6,000 adults, including adults aged 65 years and above, vaccine-naïve adults, and adults with prior pneumococcal vaccination.
Pfizer Vaccines global president Nanette Cocero said: “PREVNAR 20 builds on Pfizer’s legacy of more than two decades of experience in developing and supplying innovative pneumococcal conjugate vaccines that have had a tangible impact on global disease burden.
“We are thrilled with this approval as it furthers our mission to expand protection against disease-causing bacteria serotypes to help prevent potentially serious respiratory infections like pneumococcal pneumonia throughout the year.”
In February this year, the European Medicines Agency (EMA) has accepted Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate to prevent invasive disease and pneumonia in adults.
EMA’s Committee for Medicinal Products for Human Use (CHMP) formal review process is currently underway.