On May 24, 2021, Pfizer announced that the first enrolled subjects had 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 under an Emergency Use Authorization. The primary objective in the trial was 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

The Pfizer-BioNTech COVID-19 Vaccine, developed with BioNTech SE (Nasdaq: BNTX) based on its proprietary mRNA technology, has been shipped to 91 countries and territories¹ around the world as part of an emergency use authorization or conditional marketing authorization. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.