Pfizer's Study To Co-administer 20-valent PCV Candidate With Third Dose Of COVID-19 Vaccine

Pfizer Inc. (PFE) Monday said it has initiated a study exploring coadministration of its 20-valent pneumococcal conjugate vaccine or 20vPnC candidate along with a third dose of the Pfizer-BioNTech COVID-19 vaccine in older adults.

The company noted that the first enrolled subjects have received their immunizations as part of the new study in adults ages 65 or older exploring the coadministration of the company's 20vPnC candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration under an Emergency Use Authorization.

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 three groups in the trial include 20vPnC plus Pfizer-BioNTech COVID-19 Vaccine booster, which is a third dose of the Pfizer-BioNTech COVID-19 Vaccine; 20vPnC plus placebo; as well as Pfizer-BioNTech COVID-19 Vaccine booster plus placebo.

The Pfizer-BioNTech COVID-19 Vaccine, developed with BioNTech SE (BNTX) based on its proprietary mRNA technology, is authorized for use under an Emergency Use Authorization for active immunization to prevent covid in individuals 12 years of age and older.

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