2022-08-12| Trials & Approvals

Vaccine Protecting Against 20 Different Pneumococcal Infections Proves Effective in Trial

by Max Heirich
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On August 12, Pfizer announced that its Phase III trial evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) demonstrated positive top-line results. Based on the data, Pfizer plans to submit a supplemental Biologics License Application (sBLA) by the end of 2022 to the United States Food and Drug Administration (FDA).

Related Article: Novel Inhalable COVID-19 Therapeutic Targeting Viral Replication

What Does the Pneumococcal Infection Vaccine Protect Against?

20vPnC protects against pneumococcal infections caused by a bacteria called Streptococcus pneumoniae. These infections range from simple ear and sinus infections to more severe conditions like pneumonia and bloodstream infections.

Pneumococcal infections are most common in children aged 1-24 months. A couple of vaccines are available to prevent infection, protecting against multiple kinds of pneumococcal infections. However, they neither offer protection against every type of pneumococcal infection nor is the safety a total immunity.

Of the two classifications, 20vPnC is a pneumococcal conjugate vaccine, sharing this group with Pfizer’s other vaccines, PCV13 and PCV20, and Merck’s PCV15. Which vaccine a patient receives depends on differing age ranges and medical status. Infants generally receive the previously approved PCV13 at 2, 4, 6, and 12-15 months of age.

20vPnC builds on PCV13 as it protects against 13 stereotypes PCV13 already does in addition to 7 it does not. According to Pfizer, the 20 stereotypes that 20vPnC protects against are responsible for the majority of currently circulating pneumococcal diseases across the globe.

Topline Results from the Study Match Prior Vaccine

Pfizer initiated a Phase III clinical trial program for the pediatric indication of 20vPnC. Including four studies, the program observed the vaccine’s safety, tolerability, and immunogenicity on 4,700 infants and 800 toddlers and children of all ages.

The data from this program showed that 20vPnC resulted in robust functional responses to all 20 stereotypes. However, patients experienced local reactions, fever, and other systemic events. The local reactions included pain at the injection site, redness, and swelling. Despite that, the vaccine was still consistent with PCV13’s safety profile.

On the findings, Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development at Pfizer said, “We are encouraged by today’s data which show that if approved for a pediatric indication, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine.”

In the latter half of 2022, Pfizer plans to submit an sBLA to the FDA for approval. In addition, Pfizer intends to publish the clinical trial’s outcomes once further analysis of the data finishes. 

Related Article: In Response to Expanding Monkeypox Outbreak, FDA Approves Emergency Use of JYNNEOS Vaccine

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