BNT162b2 Vaccine for COVID-19

Recruiting at 40 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: BioNTech SE

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunocompromised, Pregnancy, Myocarditis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 1 day

1051 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of new vaccine candidates for COVID-19, focusing on different variants. Participants will receive a single dose of one of the vaccines under study, including BNT162b2 (Omi XBB.1.5). The trial seeks healthy individuals aged 12 and older who have either tested positive for COVID-19, received prior mRNA vaccine doses, or are vaccine-naïve. Participants will visit the clinic multiple times over six months to provide blood samples and nasal swabs. As a Phase 2, Phase 3 trial, this research measures how well the treatment works in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to crucial vaccine development.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the BNT162b2 vaccines, including the Omi XBB.1.5, Omi KP.2, and Omi JN.1 versions, are generally safe and well-tolerated. Earlier research found that most side effects were mild to moderate, such as pain at the injection site, tiredness, and headaches, with serious side effects being rare.

For the BNT162b2 (Omi XBB.1.5) vaccine, safety data from previous studies show it is well-tolerated, with side effects similar to other COVID-19 vaccines. Results suggest that serious adverse reactions are uncommon.

The BNT162b2 (Omi KP.2) vaccine is also reported to be safe. Studies indicate it has received FDA approval for use against specific strains, supporting its safety. Most people experienced typical vaccine reactions like soreness or fatigue.

The BNT162b2 (Omi JN.1) vaccine showed a similar safety profile. Research indicates this version is safe, with mostly mild and manageable side effects.

Overall, these vaccines have been tested in many people and have shown a good safety record. Any concerns or unusual symptoms can be discussed with the healthcare team during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the BNT162b2 vaccine, particularly the Omi XBB.1.5 variant, because it targets new strains of the COVID-19 virus, including those that have evolved beyond the original strains that many current vaccines address. Unlike existing vaccines, which were designed to combat earlier strains, this treatment is tailored to combat newer variants, potentially offering enhanced protection. This ongoing adaptability and specificity make it a promising candidate for more effectively managing the evolving virus landscape.

What evidence suggests that this trial's treatments could be effective for COVID-19?

Studies have shown that the BNT162b2 vaccine, updated for the XBB.1.5 variant, effectively prevents severe COVID-19 cases, including hospitalizations. It works well regardless of prior vaccination status, and no current evidence suggests its effectiveness decreases over time. Research indicates that this vaccine strengthens the immune system specifically against the Omicron variant. In this trial, some participants will receive the BNT162b2 vaccine updated for the XBB.1.5 variant, while others will receive the version updated for the JN.1 variant. Early data suggest that the JN.1 variant vaccine is safe, easy to tolerate, and successfully triggers an immune response. Overall, these findings suggest that the BNT162b2 vaccines can effectively help protect against COVID-19 caused by recent variants. ^{1 2 5 6 7}

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 healthy individuals aged 12 and older. Substudy A includes those who've had at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the last being an Omicron BA.4/BA.5-adapted bivalent vaccine over 150 days ago. Substudy B is for COVID-19 vaccine-naïve people who tested positive for SARS-CoV-2 more than 28 days before.

Inclusion Criteria

I am generally healthy, even if I have a stable, pre-existing condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 30 µg dose of BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity, with blood samples and nasal swabs taken at each visit

6 months

At least 5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BNT162b2 (Omi XBB.1.5)

Trial Overview The study tests a new RNA-based COVID-19 vaccine candidate, BNT162b2 (Omi XBB.1.5), targeting recent variants as a single dose to evaluate safety and immune response over about six months with at least five clinic visits involving blood samples and nasal swabs.

How Is the Trial Designed?

Group I: SSC: Group 4 Experimental Treatment 1 Intervention

Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.

Group II: SSC: Group 3 Experimental Treatment 1 Intervention

Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.

Group III: SSC - Group 5 Experimental Treatment 1 Intervention

Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1.

Group IV: SSB: Group 2 Experimental Treatment 1 Intervention

Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1

Group V: SSA: Group 1 Experimental Treatment 1 Intervention

Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.

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

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10010049/

Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04955626

Study Details | NCT04955626 | To Evaluate the Safety, ... Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33301246/

Safety and Efficacy of the BNT162b2 mRNA Covid-19 ... Conclusions: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25001665

A phase 2/3 trial to investigate the safety and ... Here we provide preliminary data on the safety, tolerability, and immunogenicity of a monovalent Omicron JN.1-adapted BNT162b2 vaccine.

5. fda.gov fda.gov/media/188871/download?attachment

Statistical Review Memo, August 27, 2025 - COMIRNATY This study will assess the efficacy of. BNT162b2 in the prevention of laboratory-confirmed COVID-19 disease following 1 dose of BNT162b2 (LP.

6. clinicaltrials.biontech.com clinicaltrials.biontech.com/trials/BNT162-21

Safety and Effects of an Investigational COVID‑19 Vaccine ... This is an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05997290

NCT05997290 | A Study to Learn About New COVD-19 ... This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,. in people who are 12 years of age ...