The PREVNAR 20 vaccine has been developed based on more than 20 years of Pfizer’s research in developing pneumococcal conjugate vaccines, and further advances the US drugmaker’s paediatric pneumococcal vaccine portfolio


Prevnar 20is a 20-valent pneumococcal vaccine. (Credit: Mufid Majnun on Unsplash)

Pfizer has received expanded US Food and Drug Administration (FDA) approval for its 20-valent pneumococcal vaccine candidate, Prevnar 20, to include infants and children.

Prevnar 20 is a conjugate vaccine that offers prevention against invasive pneumococcal disease (IPD), caused by 20 serotypes of Streptococcus pneumoniae (pneumococcus).

It is already approved in the US, for the prevention of IPD in adults.

The current FDA approval expands its indication to include infants and children, aged six weeks to 17 years.

Prevnar 20 is also indicated for the prevention of otitis media in infants, aged six weeks through five years, caused by the original seven serotypes contained in the vaccine.

Pfizer vaccine research and development senior vice president and chief scientific officer Annaliesa Anderson said: “Today’s FDA approval of our vaccine, Prevnar 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children.

“This important Prevnar 20 approval builds on more than 20 years of real-world impact with Prevnar and Prevnar 13, safety data, and effectiveness; highlighting Pfizer’s leadership in developing ground-breaking pneumococcal conjugate vaccines to help protect infants and their families from life-threatening infections.

“We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine.”

Pfizer developed the Prevnar 20 vaccine based on its FDA-approved Prevnar 13 vaccine and includes seven additional serotypes, 8, 10A, 11A, 12F, 15B, 22F and 33F.

The additional serotypes are linked to antibiotic resistance, heightened disease severity, invasive potential, and prevalence in paediatric pneumococcal cases.

The FDA’s approval for Prevnar 20 is based on results from the Phase 2 and Phase 3 clinical trial programs that evaluated the vaccine in the paediatric population.

In three core Phase 3 paediatric studies, Prevnar 20 showed safety, tolerability, and immunogenicity, along with positive results in a Phase 3 study conducted in the US.

The vaccine also showed positive safety and immunogenicity results in a Phase 2 study.

In August 2020, the US FDA granted Breakthrough Therapy Designation for Prevnar 20 to prevent invasive pneumococcal disease (IPD) in the paediatric population.

In August last year, the US drugmaker announced positive results from US Phase 3 study in infants, and secured the US FDA priority review for Prevnar 20, in January this year.