Pfizer’s next-generation pneumococcal vaccine has been approved by the US Food and Drug Administration (FDA) to help protect infants and children aged six weeks to 17 years against invasive pneumococcal disease (IPD).
Prevnar 20 builds on the company’s approved Prevnar 13 vaccine and includes seven more serotypes of the streptococcus pneumoniae bacteria that causes IPD.
The additional serotypes have been shown to be associated with antibiotic resistance, heightened disease severity, invasive potential and prevalence in paediatric pneumococcal cases, Pfizer said.
They have also been found to be among some of the most common serotypes causing paediatric IPD in countries with existing pneumococcal vaccination programmes.
The updated vaccine has also been approved for the prevention of otitis media – an infection of the middle ear – caused by streptococcus pneumoniae bacteria in infants aged six weeks to five years.
Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development, Pfizer, said: “[The] 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 US infants and children.”
While there are more than 100 different serotypes of streptococcus pneumoniae, a selected number are responsible for the majority of pneumococcal infections and Pfizer reports that there remains ‘a considerable burden of disease’ attributed to those not currently included in approved vaccines.
The FDA’s decision for Prevnar 20 is based on results from the phase 2 and phase 3 clinical trial programmes that showed the vaccine’s safety and tolerability was similar to Prevnar 13.
“We are thrilled with this approval as it signifies a new chapter in paediatric pneumococcal conjugate vaccination,” said Dr Sheldon Kaplan, chief, division of infectious diseases, department of paediatrics, Baylor College of Medicine and chief, infectious disease service, Texas Children’s Hospital.
“Based on the real-world results we’ve observed with Prevnar 13, Prevnar 20 has the potential to greatly reduce the substantial remaining burden of pneumococcal disease among US infants and children and help protect them against this potentially serious disease,” he added.