COMIRNATY Vaccine Long-Term Effects for Myocarditis

Recruiting at 37 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Pfizer

Disqualifiers: Pre-existing cardiac conditions, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age \<21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.

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 trial coordinators or your doctor.

What data supports the effectiveness of the COMIRNATY vaccine for myocarditis?

The Pfizer-BioNTech COVID-19 vaccine, also known as COMIRNATY, has been shown to reduce confirmed infections and severe illness even against common variants of the virus, particularly after the third (booster) dose. Despite some cases of myocarditis (inflammation of the heart muscle) reported, the benefits of vaccination, such as preventing severe COVID-19, likely outweigh the risks. ^{1 2 3 4 5}

Is the COMIRNATY (Pfizer-BioNTech) vaccine generally safe in humans?

The COMIRNATY (Pfizer-BioNTech) vaccine has been associated with a risk of myocarditis (inflammation of the heart muscle), especially in young males after the second dose, but most cases are mild. Safety data from studies show that adverse events are generally rare and the vaccine is widely used, with millions of doses administered. ^{1 3 4 6 7}

How does the COMIRNATY vaccine differ from other treatments for myocarditis?

The COMIRNATY vaccine, an mRNA-based COVID-19 vaccine, is unique because it is primarily designed to prevent COVID-19 rather than treat myocarditis. However, it has been associated with a risk of myocarditis, particularly in young males after the second dose, which is not a typical feature of other myocarditis treatments. Unlike standard myocarditis treatments, which focus on managing symptoms and inflammation, the vaccine's role is preventive against COVID-19, with myocarditis being a rare side effect. ^{1 3 4 6 8}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This study is for people under 21 who've had myocarditis/pericarditis symptoms within a week of getting the COMIRNATY COVID-19 vaccine. They must be able to consent or have a guardian who can, and should not have other heart conditions that could affect results.

Inclusion Criteria

I likely have or am confirmed to have heart inflammation.

I have COVID-19 or MIS-C with heart inflammation not caused by the COMINARTY vaccine.

I was evaluated in the ER or hospitalized at a participating medical center.

Exclusion Criteria

Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement)

I do not have serious heart conditions that could affect the study.

The site will check if there could be another reason for heart inflammation based on their usual way of looking for causes of heart inflammation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Initial Assessment

Participants are enrolled and initially assessed for myocarditis/pericarditis following COMIRNATY or COVID-19/MIS-C

2 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term cardiac and non-cardiac outcomes, including quality of life assessments

Up to 5 years

Regular follow-up visits as per protocol

Treatment Details

Interventions

• COMIRNATY
• Diagnostic Test

Trial Overview The trial investigates the safety of the COMIRNATY vaccine in preventing COVID-19 and its potential link to heart inflammation (myocarditis/pericarditis). Participants will undergo cardiac imaging over up to five years to monitor long-term effects.

Participant Groups

Group I: myocarditis/pericarditis following COVID-19 or MIS-C Experimental Treatment 1 Intervention

myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY

Group II: myocarditis/pericarditis following COMIRNATY Experimental Treatment 1 Intervention

myocarditis/pericarditis following COMIRNATY within 28 days of dose

COMIRNATY is already approved in European Union, United States, Canada, United Kingdom for the following indications:

Approved in European Union as Comirnaty for:

• Prevention of COVID-19 in individuals aged 12 years and older

Approved in United States as Comirnaty for:

• Prevention of COVID-19 in individuals aged 12 years and older

Approved in Canada as Comirnaty for:

• Prevention of COVID-19 in individuals aged 12 years and older

Approved in United Kingdom as Comirnaty for:

• Prevention of COVID-19 in individuals aged 12 years and older

Who Is Running the Clinical Trial?

Pfizer

Lead 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

National Health Lung Blood Institute

Collaborator

Trials

1

Recruited

300+

Carelon Research

Collaborator

Trials

76

Recruited

125,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

HealthCore-NERI

Collaborator

Trials

73

Recruited

111,000+

Findings from Research

A large national study in Israel found that mRNA COVID-19 vaccines, particularly the second dose, are associated with an increased risk of myocarditis, especially in young males, with an incidence ratio of 5.34 compared to historical data.

Despite the risk of myocarditis, the third booster dose of the Pfizer-BioNTech vaccine has been effective in reducing COVID-19 infections and severe illness, although a case of severe myocarditis following this booster has been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Acute Myocarditis after the Third (Booster) Dose of mRNA COVID-19 Vaccination. Mengesha, B., Asenov, AG., Hirsh-Raccah, B., et al.[2022]

In a study of 4 patients diagnosed with myocarditis after receiving the COVID-19 booster vaccine, symptoms appeared on average 5.75 days post-vaccination, and the cardiac imaging results indicated relatively mild conditions.

The cardiac magnetic resonance imaging (CMR) findings were consistent with previous reports following the first two vaccine doses, suggesting that myocarditis cases after the booster may not be more severe, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Series of Myocarditis Following Third (Booster) Dose of COVID-19 Vaccination: Magnetic Resonance Imaging Study. Shiyovich, A., Witberg, G., Aviv, Y., et al.[2022]

In a study of 324 health care workers receiving the fourth dose of the BNT162b2 mRNA vaccine, only 0.62% experienced vaccine-related myocardial injury, indicating a very low incidence of this adverse effect.

Both cases of myocardial injury were mild or asymptomatic, with no significant clinical consequences, suggesting that the fourth vaccine dose is generally safe for healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons. Levi, N., Moravsky, G., Weitsman, T., et al.[2023]

A rare case of myocarditis was reported in a 17-year-old boy following the first dose of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine, highlighting that myocarditis can occur even after the initial vaccination, not just after the second dose.

This case adds to the understanding of potential adverse events related to mRNA COVID-19 vaccines, emphasizing the need for monitoring and awareness of myocarditis symptoms post-vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Myocarditis Presenting With a Hyperechoic Nodule After the First Dose of COVID-19 mRNA Vaccine. Park, S., You, J.[2023]

Among 177 million fully vaccinated individuals, there have been 1,148 reported cases of myocarditis or pericarditis, indicating a rare potential side effect of the Pfizer mRNA COVID-19 vaccine.

A case study of a 16-year-old male who developed acute myopericarditis after his second dose showed that with anti-inflammatory treatment, he made a full recovery, suggesting that the benefits of vaccination likely outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of myopericarditis following administration of the Pfizer COVID-19 vaccine. Morton, Z., Green, D., Grisham, M.[2022]

In a study of 2030 healthcare workers, those previously infected with COVID-19 reported a higher incidence of side effects after the first dose of the Comirnaty vaccine compared to those who had not been infected, with 46.76% experiencing side effects versus 29.15%.

After the second dose, the side effect rate for previously infected individuals was lower (63.23%) compared to those not previously infected (70.79%), suggesting that prior infection may influence the vaccine's side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. Ossato, A., Tessari, R., Trabucchi, C., et al.[2023]

Three patients experienced chest pain after receiving either the Pfizer/BioNTech or Moderna COVID-19 vaccines, which was linked to myocarditis as confirmed by clinical presentation, biomarkers, and cardiac MRI.

This report highlights the importance of monitoring and reporting potential side effects of COVID-19 vaccines to enhance understanding of their safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myocarditis in the Setting of Recent COVID-19 Vaccination. Onderko, L., Starobin, B., Riviere, AE., et al.[2021]

A 15-year-old developed myocarditis four days after receiving the second dose of the BNT162b2 mRNA vaccine, presenting primarily with chest pain and elevated Troponin-I levels.

The myocarditis was mild, with preserved left ventricular function, and symptoms resolved quickly with symptomatic treatment and bed rest, indicating a generally favorable outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Myocarditis following mRNA vaccine]. Formanek, A., Wagner, T., Newrkla, S., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Severe Acute Myocarditis after the Third (Booster) Dose of mRNA COVID-19 Vaccination. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Case Series of Myocarditis Following Third (Booster) Dose of COVID-19 Vaccination: Magnetic Resonance Imaging Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

A Case of Myocarditis Presenting With a Hyperechoic Nodule After the First Dose of COVID-19 mRNA Vaccine. [2023]

5. Romania pubmed.ncbi.nlm.nih.gov

A case of myopericarditis following administration of the Pfizer COVID-19 vaccine. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Myocarditis in the Setting of Recent COVID-19 Vaccination. [2021]

8. Austria pubmed.ncbi.nlm.nih.gov

[Myocarditis following mRNA vaccine]. [2023]