What side effects are associated with this type of intervention?

The most common side effects of mRNA-based COVID-19 vaccines, such as mRNA-1273, include mild to moderate reactions like pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea. Rare but more severe side effects have been reported, including myocarditis/pericarditis, thrombosis with thrombocytopenia syndrome (TTS), and Guillain-Barré Syndrome (GBS). Other treatments for COVID-19, such as antiviral drugs and monoclonal antibodies, can also cause side effects like gastrointestinal symptoms, allergic reactions, and liver enzyme abnormalities.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several mRNA-based vaccines for the treatment of COVID-19, including the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) and the Moderna COVID-19 vaccine (mRNA-1273). These vaccines work by encoding the spike protein of SARS-CoV-2, which triggers an immune response to protect against the virus. Additionally, the FDA has approved the use of bivalent vaccines that target both the original virus and specific variants, such as the Moderna bivalent booster for individuals aged 6 years and older.

What other types of research exist?

Promising novel alternatives to the mRNA-1273 vaccine for COVID-19 patients in 2024 include: 1. Protein subunit vaccines (e.g., Novavax's NVX-CoV2373) which use purified pieces of the virus to stimulate an immune response. 2. Viral vector vaccines (e.g., Johnson & Johnson's Ad26.COV2.S) which use a modified virus to deliver genetic material from SARS-CoV-2 to cells. 3. Next-generation mRNA vaccines that target multiple variants or use self-amplifying RNA for enhanced immune response. 4. DNA vaccines (e.g., Inovio's INO-4800) which use plasmid DNA to induce an immune response. These alternatives are in various stages of development and have shown promising results in clinical trials.

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Vaccine

mRNA COVID-19 Vaccine for Children

Q: What is the mechanism of action of this treatment?

The mRNA-1273 vaccine, like other mRNA-based vaccines, works by encoding the spike protein of SARS-CoV-2, prompting the body to produce this protein and subsequently inducing an immune response. This prepares the immune system to recognize and combat the actual virus if encountered. Antiviral drugs, such as remdesivir, inhibit viral replication by targeting viral RNA polymerase, reducing the viral load in the body. Monoclonal antibodies, like those targeting the spike protein, neutralize the virus by preventing it from entering human cells. These treatments are crucial for COVID-19 patients as they either prevent infection, reduce the severity of the disease, or aid in faster recovery by enhancing the body's ability to fight the virus.

Phase 2 & 3

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

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

Must have

Key

For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).

Must not have

Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment.

Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 57 (1 month after second injection)

Summary

This trial is testing the mRNA-1273 COVID-19 vaccine in healthy children. The vaccine helps the body learn to fight COVID-19 by showing it a harmless piece of the virus. The study aims to find out how safe and effective the vaccine is for children.

Who is the study for?

Healthy children aged 6 months to less than 12 years, including those with stable chronic diseases like asthma or diabetes. They must not have had a recent SARS-CoV-2 infection, exposure, or COVID-19 vaccination. Participants should meet specific growth standards and their parents must agree to follow the study's procedures.

What is being tested?

The trial is testing different doses of mRNA-1273 COVID-19 vaccine in children through intramuscular injections. It will explore the safety and effectiveness of two initial doses plus an optional third dose or booster.

What are the potential side effects?

Possible side effects may include pain at the injection site, fever, fatigue, headache, muscle pain, chills, joint pain and nausea. Side effects are generally mild to moderate but can vary for each child.

Eligibility Criteria

Inclusion Criteria

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

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It looks like the criterion is incomplete. Could you please provide more details or context for me to assist you accurately?

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My child was born full-term and weighed at least 2.5 kg.

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My child's BMI is at or above the 3rd percentile for their age.

Exclusion Criteria

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

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I haven't received COVID-19 prophylaxis treatments like monoclonal antibodies in the last 6 months.

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I have received a vaccine for COVID-19 or another coronavirus.

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I haven't had COVID-19 or been in close contact with someone who has, in the last 2 weeks.

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I have not received blood products like red cells or platelets in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 57 (1 month after second injection)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 57 (1 month after second injection)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 (1 month after second injection) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19

Secondary study objectives

Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Number of Participants with a First Occurrence of COVID-19

Side effects data

From 2022 Phase 4 trial • 41 Patients • NCT04792567

24%

COVID-19

18%

Lymphopenia

18%

Injection site pain

12%

Liver function test increased

12%

Pain in extremity

12%

Multiple sclerosis relapse

Escherichia urinary tract infection

Visual impairment

Fatigue

Pyrexia

Injection site pustule

Rhinitis

Urinary tract infection

Upper limb fracture

Back pain

Myalgia

Dizziness

Headache

VIth nerve paralysis

Menstrual disorder

Cough

Flushing

100%

80%

60%

40%

20%

Study treatment Arm

Siponimod Continuous

Siponimod Interrupted

DMT or No MS Treatment

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1273Experimental Treatment2 Interventions

Part 1: Participants will receive 2 IM injections of mRNA-1273 at doses pre-specified for this study, on Days 1 and 29. Participants will be offered an optional BD of mRNA-1273 lower than the dose chosen for primary series, ≥6 months after Dose 2. After protocol amendment (PA) 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214. Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1 on Days 1 and 29. Participants (6 to \<12 year) will be offered an optional BD of mRNA-1273 lower than the dose chosen for primary series, ≥6 months after Dose 2. After PA 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214. Part 3: Participants will receive 2 IM injections of mRNA-1273 on Days 1 and 29 as primary series then 1 IM injection as Dose 3, on Day 149 ≥3 months and ≤5 months after receipt of Dose 2 of primary series. All 3 injections will be administered at lower dose than that of Part 1.

Group II: PlaceboPlacebo Group3 Interventions

Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo on Day 1 and Day 29. Participants (6 to \<12 year old) will be offered an optional BD of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2. After PA 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1273.214

2021

Completed Phase 3

~20910

mRNA-1273

2021

Completed Phase 4

~58720

0 / 7Eligibility 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

The mRNA-1273 vaccine, like other mRNA-based vaccines, works by encoding the spike protein of SARS-CoV-2, prompting the body to produce this protein and subsequently inducing an immune response. This prepares the immune system to recognize and combat the actual virus if encountered. Antiviral drugs, such as remdesivir, inhibit viral replication by targeting viral RNA polymerase, reducing the viral load in the body. Monoclonal antibodies, like those targeting the spike protein, neutralize the virus by preventing it from entering human cells. These treatments are crucial for COVID-19 patients as they either prevent infection, reduce the severity of the disease, or aid in faster recovery by enhancing the body's ability to fight the virus.

Insights on the mechanisms of action of ozone in the medical therapy against COVID-19.mRNA-1273 efficacy in a severe COVID-19 model: attenuated activation of pulmonary immune cells after challenge.