Pfizer’s pneumococcal vaccine approved by the FDA for adults aged 18 years or older

Pfizer’s PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) has been approved by the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia in adults aged 18 years and older. The vaccine helps protect against 20 streptococcus pneumoniae (pneumococcus) serotypes.

Recommendations on the safe and appropriate use of pneumococcal vaccines in adults are expected to be discussed and updated when the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meets in October.

“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,” said Kathrin Jansen, Senior Vice President and Head of Vaccine Research & Development, Pfizer. “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.”

It is estimated that, in the US, up to 250,000 cases of invasive pneumococcal disease (IPD) – including bacteraemia and meningitis – and community-acquired pneumonia are caused by 20 serotypes, along with more than 10,000 deaths in adults aged 18 years or older.

The 20 serotypes that PREVNAR 20 offers protection against cause more than half of all cases of IPD – including bacteraemia and meningitis – in adults aged 65 or older in the US, with seven of the serotypes that PREVNAR 20 offers protection against causing 40% of pneumococcal disease cases and deaths in the US.

Results from Pfizer’s three phase 3 trials, as well as from phase 1 and 2 trials, were used by the FDA to evaluate the safety and immunogenicity of the vaccine. The phase 3 trials, involving more than 6,000 adult subjects 18 years and older, included adults aged 65 and older, vaccine-naïve adults and adults with prior pneumococcal vaccination.

“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,” said Nanette Cocero, Global President of Pfizer Vaccines. “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 September 2017, Fast Track designation was granted by the FDA for PREVNAR 20 for use in adults aged 18 years or older. A year later, in September 2018, Pfizer received Breakthrough Therapy Designation from the FDA for PREVNAR 20.

Earlier this year, in February 2021, Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate was accepted by the European Medicines Agency (EMA) for review, and a formal review by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is currently ongoing.