COVID-19 Vaccine for COVID-19

Recruiting at 13 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: BioNTech SE

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.

This study is seeking participants who:

* are medically stable

* have not had a recent COVID-19 infection or a recent COVID-19 vaccination

* have not received certain routine vaccines recently

* participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19.

Participants in Cohort 1 of this study will receive a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. The study team and participants will know which injection they receive.

Participants in Cohort 2 of this study will randomly receive 1 injection into their upper arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.

Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people aged 5 and older. Those ages 5-64 must have at least one health condition that raises their risk of severe COVID-19. All participants should be medically stable, not recently infected with COVID-19, and haven't had recent COVID vaccines or certain other routine shots.

Inclusion Criteria

I am at least 5 years old.

I am between 5 and 64 years old and have a health condition that raises my risk for severe COVID-19.

Exclusion Criteria

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)

I have had myocarditis or pericarditis in the past.

I had a COVID-19 vaccine or infection within the last 3 months.

What Are the Treatments Tested in This Trial?

Interventions

BNT162b2

Trial Overview

The study tests updated BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in two groups: one group gets a single known dose; the other randomly receives one of three vaccine versions. The study lasts about 6 months with regular check-ups and sample collection.