No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
700 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for
This trial is looking for children and adults who are at risk for serious COVID-19. Participants will receive a COVID-19 vaccine injection and report any side effects over about 6 months.
Are You a Good Fit for This Trial?
You may be able to join if
I am 5 years of age or older.
I have at least 1 medical condition that increases my risk of severe COVID-19.
You may not be able to join if
I have had a severe allergic reaction to a vaccine.
I have a history of myocarditis or pericarditis.
I received a COVID-19 vaccine or tested positive for COVID-19 in the last 90 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
Key Inclusion criteria:
* Participants 5 years of age or older.
* Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.
Key Exclusion Criteria:
* History of severe adverse reaction associated with a vaccine and/or …
Key Inclusion criteria:
* Participants 5 years of age or older.
* Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.
Key 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).
* History of myocarditis or pericarditis.
* Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment.
Refer to the study contact for further eligibility details.
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