mRNA COVID-19 Vaccine Safety With Childhood Vaccines

No longer recruiting at 4 trial locations

Overseen By Emily A Randolph, MBA

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must be taking: mRNA COVID-19 vaccine

Must not be taking: Antipyretics, Steroids

Disqualifiers: Seizures, Allergies, Immunosuppression, 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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of administering the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty or BNT162b2) alongside other routine childhood vaccinations in a single visit, compared to separate visits. The researchers aim to determine if vaccinating children against COVID-19 and other diseases simultaneously is as safe and effective. Children due for these vaccinations, whose parents plan to vaccinate them, may be suitable participants. This study could simplify vaccine appointments for families and help ensure children remain protected against multiple illnesses efficiently. As a Phase 4 trial, this research involves an FDA-approved vaccine and focuses on understanding its benefits when given with other vaccines, offering families a chance to contribute to optimizing vaccination strategies.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, if your child is on long-term steroids or has received certain vaccines recently, they may not be eligible to participate.

What is the safety track record for these treatments?

Research shows that the Pfizer-BioNTech COVID-19 vaccine is generally well-tolerated. In studies, about 11% of vaccine recipients reported severe reactions like high fever or fatigue, compared to just 2% of those who received a placebo (a harmless shot with no effect). Serious side effects, such as allergic reactions and heart inflammation, are rare.

For children, this vaccine has been thoroughly studied. Real-world data indicates it is safe for kids aged 5 to 11. Some children might experience side effects like a sore arm or tiredness, but these usually resolve quickly.

Routine childhood vaccines are also well-researched and considered safe. They have been used for a long time to protect against diseases like measles and polio. Side effects are usually mild, such as a small fever or a sore spot where the shot was given.

In summary, both the Pfizer-BioNTech COVID-19 vaccine and routine childhood vaccines have strong safety records. Most side effects, if they occur, are mild and resolve on their own. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the safety and practicality of giving the mRNA COVID-19 vaccine alongside routine childhood vaccinations. Unlike the current standard where vaccines are usually given in separate visits to avoid overwhelming the immune system, this study looks into simultaneous vaccination, which could simplify the vaccination schedule for kids and increase overall vaccination rates. By testing both sequential and simultaneous vaccination strategies, researchers aim to discover if combining these vaccines is just as safe and effective, which could lead to more efficient and convenient healthcare practices for families.

What evidence suggests that this trial's treatments could be effective?

Research has shown that the Pfizer-BioNTech COVID-19 vaccine effectively prevents COVID-19, with studies indicating up to 95% effectiveness in individuals aged 16 and older. The vaccine is generally safe, with most side effects being mild. In this trial, participants in the simultaneous vaccination arm will receive the COVID-19 vaccine alongside routine childhood vaccines during the same visit. No evidence suggests that the COVID-19 vaccine reduces the effectiveness of routine vaccines when administered together. Early data indicates no significant increase in side effects when given simultaneously. Therefore, both the COVID-19 vaccine and routine shots should remain effective when administered at the same time. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael J Smith, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for children aged 6 months to under 5 years who are due for their mRNA COVID-19 vaccine and at least one other non-live routine vaccine. Parents must be willing to delay the COVID-19 shot up to 3 weeks, consent to medical information release, and ensure follow-up. Children with active COVID-19, history of MIS-C, recent or planned experimental treatments, immunosuppression, certain severe allergies or reactions to vaccines are excluded.

Inclusion Criteria

The parent/LAR must be available for follow-up and must at minimum have telephone access

The parent/LAR must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed)

I intend for my child to receive the mRNA COVID-19 vaccine and another recommended vaccine.

Exclusion Criteria

Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Any child or grandchild of a study investigator or study team member

You had a serious allergic reaction in the past to a vaccine or any of its ingredients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Vaccination

Participants receive either simultaneous or sequential vaccinations, including mRNA COVID-19 and routine childhood vaccines

1 day

Visit 1 and Visit 2

Monitoring

Participants are monitored for fever and other adverse events for 7 days following each vaccination visit

7 days

Follow-up

Participants are monitored for serious adverse events and parental perceptions are assessed

Up to 105 days

What Are the Treatments Tested in This Trial?

Interventions

• Pfizer-BioNTech COVID-19 Vaccine
• Routine Childhood Vaccinations

Trial Overview The study tests the safety of giving young children the mRNA COVID-19 vaccine simultaneously with other childhood vaccines compared to spacing them out over separate visits. It's a prospective (looking forward in time), randomized (participants randomly assigned), open-label (no placebo control) trial.

How Is the Trial Designed?

Group I: Simultaneous vaccination arm Experimental Treatment 2 Interventions

The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.

Group II: Sequential vaccination arm Experimental Treatment 2 Interventions

The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.

Pfizer-BioNTech COVID-19 Vaccine 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 disease in individuals 12 years of age and older

Approved in United States as Comirnaty for:

• Prevention of COVID-19 disease in individuals 6 months of age and older

Approved in Canada as Comirnaty for:

• Prevention of COVID-19 disease in individuals 6 months of age and older

Approved in United Kingdom as Comirnaty for:

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

A study analyzing 4838 reports from the European database EudraVigilance found that mRNA COVID-19 vaccines, particularly BNT162b2, have a favorable safety profile in children aged 5-11, with serious adverse events reported in 38.7% of cases, but most were manageable.

The most common side effects included fever, headache, and vomiting, with only 20 cases of Multisystem Inflammatory Syndrome reported, indicating that while monitoring is essential, the benefits of vaccination in this age group outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study. Zinzi, A., Gaio, M., Liguori, V., et al.[2023]

The Pfizer-BioNTech COVID-19 vaccine (Comirnaty) has been approved for individuals aged 16 and older and is also authorized for emergency use in children aged 5-11, with over 248 million doses administered in the U.S. by November 2021.

The vaccine demonstrates high efficacy of over 90% in preventing COVID-19 in children aged 5-11, and the Advisory Committee on Immunization Practices (ACIP) concluded that the benefits of vaccination outweigh the risks, emphasizing its importance in protecting children and reducing virus transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021. Woodworth, KR., Moulia, D., Collins, JP., et al.[2021]

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]

The active pharmacovigilance study conducted in central Italy assessed the safety of the mRNA BNT162b2 COVID-19 vaccine in children aged 5-11 years, providing important data on its safety profile.

The correspondence highlights the ongoing discussion and scrutiny regarding the vaccine's safety in this age group, emphasizing the need for transparent communication of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Author's reply to correspondence. Ripabelli, G., Salzo, A., Tamburro, M.[2023]

A survey of 197 parents in central Italy revealed that 84.3% of children aged 5-11 experienced at least one adverse event after receiving the mRNA BNT162b2 vaccine, with most events being mild to moderate in severity.

The most common adverse reactions were local symptoms at the injection site, with no serious adverse events reported, indicating a favorable safety profile for the vaccine in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy. Ripabelli, G., Sammarco, ML., D'Amico, A., et al.[2023]

In a case series of 15 children hospitalized with myocarditis after receiving the Pfizer-BioNTech COVID-19 vaccine, symptoms typically appeared 1 to 6 days post-vaccination, with chest pain being the most common symptom.

Despite the diagnosis of myocarditis, the patients were mildly affected overall, with most showing resolution of symptoms shortly after hospitalization, indicating that while myocarditis can occur, it appears to be manageable in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Myocarditis With BNT162b2 Messenger RNA COVID-19 Vaccine in a Case Series of Children. Dionne, A., Sperotto, F., Chamberlain, S., et al.[2022]

A study involving 21 children with a history of pediatric inflammatory syndrome temporally associated with COVID-19 (PIMS-TS) and 71 healthy controls found that the Pfizer-BioNTech COVID-19 mRNA vaccine (Comirnaty®) was safe, with no severe adverse events reported in either group.

The frequency of adverse events was similar between the PIMS group and controls, although local hardening at the injection site was more common in the PIMS group. Importantly, the vaccine did not trigger any PIMS-like symptoms in any of the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 mRNA BNT162b2 vaccine safety and B-cell and T-cell reactogenicity among children with a history of paediatric multisystem inflammatory syndrome temporally associated with COVID-19 (PIMS-TS) - preliminary study. Ludwikowska, KM., Popiel, A., Matkowska-Kocjan, A., et al.[2023]

Citations

1. cdc.gov cdc.gov/acip/grade/covid-19-pfizer-biontech-vaccine.html

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.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2034577

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9746476/

Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA ... We reviewed the safety profile of the BNT162b2 COVID-19 vaccine in adolescents using mostly real-world data to assist decision-making.

4. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating

Pfizer and BioNTech Announce Topline Data ... Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include: Non-severe allergic reactions ...

5. pfizer.com pfizer.com/news/announcements/pfizer-reaffirms-safety-and-efficacy-covid-19-vaccines

Pfizer Reaffirms Safety and Efficacy of COVID-19 Vaccines Recent vaccine effectiveness during 2024–2025 season: In a recent study, the latest Pfizer-BioNTech KP.2 vaccine showed 41–75% effectiveness ( ...

6. cdc.gov cdc.gov/covid/hcp/vaccine-considerations/index.html

Interim Clinical Considerations for Use of COVID-19 ... Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for children ages 6 months–4 years. The only FDA-approved COVID-19 vaccine available for this age ...

7. pfizer.com pfizer.com/science/coronavirus/updates

All COVID-19 Updates Pfizer Inc. and BioNTech SE today announced that they submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY® (COVID-19 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9746364/

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech ... This survey investigated on adverse events after vaccination with mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine in children aged 5–11 years ...