25500 Participants Needed

COVID-19 Vaccine for Coronavirus

Recruiting at 205 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 3
Sponsor: BioNTech SE
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?

This trial explores the effectiveness of the BNT162b2 COVID-19 vaccine in people aged 50 to 64 without serious health issues. Researchers aim to compare the vaccine's performance to a placebo, which resembles the vaccine but lacks the active ingredient. The goal is to assess how well the vaccine protects against COVID-19 in this age group. Candidates should be healthy, have not contracted COVID-19 in the past three months, and have not been recently vaccinated for COVID-19. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that the BNT162b2 Vaccine is likely to be safe for humans?

Studies have shown that the BNT162b2 vaccine, developed by Pfizer-BioNTech, is generally safe. Participants in the research received two doses, which provided 95% protection against COVID-19. Reported side effects were usually mild, such as sore arms and fatigue, while serious side effects were rare.

Most data comes from individuals aged 16 and older, but it also offers insight into the vaccine's effectiveness for those aged 50 to 64. Real-world safety data supports this, indicating that the vaccine is reassuringly safe. Although rare reports of heart inflammation (myocarditis) have occurred, these cases remain uncommon and are closely monitored.

Overall, the BNT162b2 vaccine has been well-tolerated in both studies and real-life use.12345

Why do researchers think this study treatment might be promising?

The BNT162b2 vaccine is unique because it uses messenger RNA (mRNA) technology to instruct cells in the body to produce a protein similar to one found on the surface of the coronavirus. This helps the immune system recognize and fight the virus if exposed. Unlike traditional vaccines that use weakened or inactivated forms of the virus, mRNA vaccines are quicker to produce and can be adapted swiftly if the virus mutates. Researchers are excited about this approach because it offers a potentially faster and more flexible response to COVID-19.

What evidence suggests that the BNT162b2 Vaccine might be an effective treatment for COVID-19?

Research has shown that the BNT162b2 vaccine, which participants in this trial may receive, effectively prevents COVID-19. Studies have found it to be 95% effective at stopping the virus, starting 28 days after the first dose. This vaccine trains the immune system to recognize and fight the virus, reducing the risk of illness. Evidence also suggests that it is safe, with side effects similar to those of other vaccines. This makes the BNT162b2 vaccine a strong choice for protecting people aged 50 to 64 against COVID-19.34678

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This clinical trial is for healthy adults aged 50 to 64 who want to participate in a study about the COVID-19 vaccine. Participants should not have any serious health issues.

Inclusion Criteria

I am between 50 and 64 years old.
People who are healthy and, based on their medical history and a doctor's judgment, are considered suitable to join the study

Exclusion Criteria

I had COVID-19 within the last 3 months.
I have received a COVID-19 vaccine in the last 3 months or plan to during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of either the COVID-19 vaccine or a placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • BNT162b2 Vaccine

Trial Overview

The trial is testing the effectiveness of the BNT162b2 COVID-19 vaccine compared with a placebo, which does not contain active ingredients against COVID-19.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: BNT162b2 VaccineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Pfizer and BioNTech Conclude Phase 3 Study of COVID- ...

Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose; 170 confirmed ...

Pfizer-BioNTech COVID-19 Vaccine | ACIP

A systematic review of evidence on the benefits and harms of a two-dose regimen of Pfizer-BioNTech COVID-19 vaccine among persons aged ≥16 years was conducted.

2024–2025 BNT162b2 COVID-19 vaccine effectiveness in ...

Data are limited on 2024–2025 BNT162b2 COVID-19 vaccine effectiveness (VE). Methods. Retrospective cohort study among non-immunocompromised ...

Study Details | NCT06703190 | Estimated Vaccine ...

This study is a retrospective case control analysis on the real-world effectiveness of the Pfizer-BioNTech BNT162b2 vaccine (2024-2025 formulation) against ...

Safety and Efficacy of the BNT162b2 mRNA Covid-19 ...

A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34592420/

Real-world safety data for the Pfizer BNT162b2 SARS-CoV ...

The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce.

Pfizer Shares Available Analyses of Myocarditis and ...

Comirnaty, the mRNA vaccine developed by Pfizer-BioNTech, demonstrated very high effectiveness (around 95%) against SARS-CoV-2 infection in ...

Real-world safety data for the Pfizer BNT162b2 SARS-CoV ...

The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce.