Pfizer Explors Coadministration of Its 20-valent Pneumococcal Vaccine With a Third Dose of the Pfizer-BioNTech COVID-19 Vaccine

Pfizer announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA).

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow-up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.

The trial will include 600 adults who will be recruited from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine trial and will have received their second dose of the vaccine at least six months prior to entering the coadministration study. The participants are being randomized to one of three groups:

• 20vPnC plus Pfizer-BioNTech COVID-19 Vaccine booster, which is a third dose of the Pfizer-BioNTech COVID-19 Vaccine

• 20vPnC plus placebo

• Pfizer-BioNTech COVID-19 Vaccine booster plus placebo

About 20vPnC Adult

The 20vPnC candidate vaccine is in development for the prevention of invasive disease and pneumonia caused by 20 serotypes of Streptococcus pneumoniae in the vaccine in adults ages 18 years and older.

Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause pneumococcal disease,2,3,4,5,6 and have been associated with high.