COMIRNATY Vaccine Long-Term Effects for Myocarditis

Recruiting at 43 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term effects of the COMIRNATY vaccine, focusing on heart inflammation (myocarditis or pericarditis) that may occur post-vaccination. The researchers aim to determine whether these heart issues are linked to the vaccine or the COVID-19 virus itself. Participants will be followed for up to 5 years, with detailed heart tests conducted. Individuals under 21 who have been evaluated in the ER or hospitalized and have experienced heart inflammation after receiving the vaccine or after having COVID-19 may be suitable candidates. As a Phase 4 trial, the vaccine has already received FDA approval and proven effective; this research seeks to understand its benefits for more patients.

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 is the safety track record for this treatment?

Research has shown that the COMIRNATY vaccine, made by Pfizer-BioNTech, works effectively against COVID-19. However, rare cases of heart inflammation, known as myocarditis and pericarditis, have occurred after vaccination, mostly in young males aged 12 to 24.

Safety information from numerous studies indicates these cases are uncommon but are monitored closely. The FDA has added a warning to the vaccine's label about this potential risk. Although these conditions are rare, participants should be aware of them. Overall, the vaccine is well-tolerated and approved for preventing COVID-19. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the COMIRNATY vaccine because it offers new insights into the long-term effects of the vaccine, particularly concerning myocarditis and pericarditis. Unlike traditional treatments for myocarditis, which often involve anti-inflammatory medications and supportive care, this trial focuses on understanding how a vaccine itself might impact these conditions. The study is unique in that it examines cases of myocarditis/pericarditis following the COMIRNATY vaccine within 28 days of vaccination, as well as those following COVID-19 or MIS-C without exposure to the vaccine. This could help identify any specific patterns or risk factors associated with the vaccine, potentially leading to more informed vaccine use and enhanced patient safety.

What evidence suggests that the COMIRNATY vaccine is effective for preventing COVID-19?

Research shows that the COMIRNATY vaccine helps prevent COVID-19. Rare cases of heart inflammation, known as myocarditis and pericarditis, have occurred after vaccination. These cases are mostly mild and occur more often in males aged 12 to 24. This trial will compare individuals with myocarditis/pericarditis following COMIRNATY to those with myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY. An Australian study found that most people with vaccine-related myocarditis had mild cases and recovered well over time. Due to these findings, the FDA has added a warning about this risk to the vaccine's label. Overall, while there is a small risk, the benefits of vaccination against COVID-19 are much greater. ^{1 2 4 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. pfizer.com pfizer.com/news/announcements/pfizer-shares-available-analyses-myocarditis-and-covid-19-vaccines

Pfizer Shares Available Analyses of Myocarditis and ... A recent prospective study from Australia, recruiting 256 individuals with COVID-19 vaccine associated myocarditis and a longer follow-up of 18 ...

2. cdc.gov cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html

Myocarditis after COVID-19 Vaccines Cases of myocarditis and pericarditis have rarely been observed after COVID-19 vaccination in the United States and evidence from multiple vaccine safety ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9130641/

Myocarditis and/or pericarditis risk after mRNA COVID-19 ... The risk of myocarditis and/or pericarditis is higher after mRNA-1723 vaccination than BNT162b2 vaccination in those aged 18–39 years, especially in males aged ...

4. fda.gov fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and

FDA Approves Required Updated Warning in Labeling of ... The observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age.

5. tewhatuora.govt.nz tewhatuora.govt.nz/assets/Publications/Immunisation/Report-Long-term-outcomes-of-myocarditis-and-pericarditis-following-vaccination-with-Comirnaty-PfizerBioNTech-COVID-19-vaccine.pdf

Long-term outcomes of myocarditis and pericarditis ... International data suggests that most people presenting with myocarditis and/or pericarditis after vaccination with a COVID-19 vaccine have a mild form of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9273527/

Risk of myocarditis and pericarditis following BNT162b2 and ... Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males.

7. comirnaty.com comirnaty.com/

COMIRNATY® (COVID-19 Vaccine, mRNA) | Safety Info Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received ...