What side effects are associated with this type of intervention?

mRNA-based COVID-19 vaccines, such as the BNT162b RNA-based SARS-CoV-2 vaccine candidates, commonly cause mild to moderate side effects including pain at the injection site, redness, swelling, fever, fatigue, headache, muscle pain, chills, and nausea. Rare but more severe side effects include myocarditis, pericarditis, and thrombosis with thrombocytopenia syndrome (TTS). Continuous monitoring and studies are in place to ensure the safety of these vaccines.

What prior FDA approvals exist?

The FDA has approved several mRNA-based vaccines for the treatment of COVID-19, which are similar to the BNT162b RNA-based SARS-CoV-2 vaccine candidates being studied. The first mRNA vaccine approved was BNT162b2 (Comirnaty) by Pfizer-BioNTech, which instructs cells to produce the spike protein of SARS-CoV-2, eliciting an immune response. Another mRNA vaccine approved is mRNA-1273 by Moderna, which operates on a similar mechanism. Both vaccines have shown high efficacy in preventing COVID-19 and have been authorized for emergency use in various age groups and booster doses.

What other types of research exist?

Promising, novel alternatives to BNT162b RNA-based SARS-CoV-2 vaccine candidates for COVID-19 patients in 2024 include mRNA-1273 (Moderna) and Ad26.COV2.S (Johnson & Johnson). Both vaccines have shown significant effectiveness in preventing COVID-19. Additionally, ongoing research into other vaccine platforms, such as protein subunit vaccines and viral vector vaccines, may provide further options.

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New COVID-19 RNA Vaccines for COVID-19

Phase 2 & 3

Waitlist Available

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of giving signed informed consent.

Must not have

Immunosuppressants/radiotherapy: Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for 7 days following the study vaccination

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new versions of a COVID-19 vaccine to ensure they are safe and effective. It includes healthy participants who have already received previous COVID-19 vaccines. The vaccine works by using RNA to help the body recognize and fight the virus.

Who is the study for?

Healthy individuals aged 12-55 with prior COVID-19 vaccinations, including a booster shot received at least 90 days before the study. Participants must be able to consent and follow the study schedule. Excluded are those on immunosuppressants, with severe vaccine reactions or bleeding disorders, pregnant/breastfeeding women, and anyone with conditions that may risk participation.

What is being tested?

The trial is testing new RNA COVID-19 vaccines in people who've had previous vaccinations. It involves single doses of various bivalent (targeting two strains) or monovalent (single strain) vaccines to assess safety and immune response over approximately six months with multiple clinic visits for blood sampling.

What are the potential side effects?

Potential side effects include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea; rare risks may involve allergic reactions or heart inflammation as seen in very few cases with similar vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to understand and sign the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken immunosuppressants or had radiotherapy in the last 60 days.

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 7 days following the study vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 7 days following the study vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 7 days following the study vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All Cohorts: Percentage of participants reporting adverse events

All Cohorts: Percentage of participants reporting local reactions

All Cohorts: Percentage of participants reporting serious adverse events

+14 more

Secondary study objectives

Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels.

Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E).

Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E).

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

14Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)Experimental Treatment1 Intervention

Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1

Group II: Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)Experimental Treatment1 Intervention

Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Group III: Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)Experimental Treatment1 Intervention

Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Group IV: Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)Experimental Treatment1 Intervention

Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Group V: Cohort 3 - Group 2: >55 years; 30 µgExperimental Treatment1 Intervention

Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.

Group VI: Cohort 3 - Group 1: 18-55 years; 30 µgExperimental Treatment1 Intervention

Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.

Group VII: Cohort 2 -Group 1: 12-17 years; 30 µgExperimental Treatment1 Intervention

Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Group VIII: Cohort 2 - Group 5: >55 years; 60 µgExperimental Treatment1 Intervention

Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Group IX: Cohort 2 - Group 4: >55 years; 30 µgExperimental Treatment1 Intervention

Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Group X: Cohort 2 - Group 3: 18-55 years; 60 µgExperimental Treatment1 Intervention

Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Group XI: Cohort 2 - Group 2: 18-55 years; 30 µgExperimental Treatment1 Intervention

Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.

Group XII: Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)Experimental Treatment1 Intervention

Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.

Group XIII: Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)Experimental Treatment1 Intervention

Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.

Group XIV: Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)Active Control1 Intervention

Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BNT162b2 Bivalent (WT/OMI BA.1)

2022

Completed Phase 3

~1460

BNT162b2 Bivalent (WT/OMI BA.4/BA.5)

2022

Completed Phase 3

~1460

BNT162b6 Bivalent (Original/OMI BA.4/BA.5)

2022

Completed Phase 3

~1460

BNT162b7 Monovalent (OMI BA.4/BA.5)

2022

Completed Phase 3

~1460

BNT162b7 Bivalent (Original/OMI BA.4/BA.5)

2022

Completed Phase 3

~1460

BNT162b5 Bivalent (Original/OMI BA.4/BA.5)

2022

Completed Phase 3

~1460

BNT162b5 Bivalent (WT/OMI BA.2)

2022

Completed Phase 3

~1460

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

mRNA-based COVID-19 vaccines, such as the BNT162b RNA-based candidates, work by instructing cells to produce the spike protein of the SARS-CoV-2 virus. This spike protein triggers the immune system to produce antibodies and activate T-cells, preparing the body to fight off the actual virus if encountered. This mechanism is important for COVID-19 patients as it provides immunity without causing the disease, thereby reducing the risk of severe illness, hospitalization, and death.

Potential Therapeutic Targets and Vaccine Development for SARS-CoV-2/COVID-19 Pandemic Management: A Review on the Recent Update.Nanomedicine for the SARS-CoV-2: State-of-the-Art and Future Prospects.A review of potential treatments to date in COVID-19 patients according to the stage of the disease.