Prevenar 20 addresses an additional seven serotypes of Streptococcus pneumoniae that give rise to invasive pneumococcal disease. Credits: create jobs 51/Shutterstock.com

Following a US Food and Drug Administration (FDA) approval in April 2023, the European Commission (EC) has awarded marketing approval to Pfizer’s Prevenar 20 (20-valent Pneumococcal Conjugate Vaccine) for the active immunisation and protection of infants and children against common pneumococcal diseases.

The latest EU approval is based on data from four Phase III studies evaluating the safety and immunogenicity of Prevenar 20 in pediatric patients and is accompanied by a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The vaccine is marketed as Prevnar 20 in the US.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Prevenar 20 is a 20-valent pneumococcal conjugate vaccine designed to stave off invasive pneumonia, and acute otitis media caused by 20 different serotypes of Streptococcus pneumoniae. While the vaccine is already approved for use in adults, the latest approval authorises its use in those between the ages of 6 weeks and 18 years.

As per the 13 March press announcement, the latest version of the vaccine expands on Pfizer’s Prevenar 13 and includes protection against serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F, which are global causes of invasive pneumococcal disease. Marketing authorisation of Prevenar 20 addresses “the majority of currently circulating pneumococcal disease in the EU and globally,” Alexandre de Germay, executive VP of Pfizer said in the announcement.

GlobalData’s consensus forecasts predict that Prevenar 20 will bring in $3.7bn in sales in 2028. GlobalData is the parent company of Pharmaceutical Technology.

Pfizer is not alone in the space to develop vaccines against streptococcal pneumonia. Hot on the pharma giant’s heels is MSD’s investigational 21-valent pneumococcal conjugate vaccine V116. The FDA is set to make a decision on the vaccine’s approval by the Prescription Drug User Fee Act (PDUFA) date of 17 June 2024.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

MSD’s biologics licence application (BLA) is partially supported by data from the Phase III STRIDE-3 study (NCT05425732), which compared the safety, tolerability, and immunogenicity of V116 and Pfizer’s pneumococcal vaccine in adults who have not received prior pneumococcal conjugate vaccination. As per the trial findings, V116 induced non-inferior immune responses in both cohorts of the study for the serotypes common to both vaccines, and superior immune responses for 10 of the 11 serotypes included in V116 but not in PCV20. Data from the Phase III STRIDE-4, STRIDE-5, and STRIDE-6 studies also supplement the BLA.  

Note: The last paragraph was updated to correctly reflect the trial findings comparing the two pneumococcal vaccines.