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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366

Awards & highlights

Study Summary

This trial is testing a vaccine for children. It will evaluate how well it works given in 2 or 3 doses, with an optional booster dose.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody

Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody

Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation

+8 more

Secondary outcome measures

GM Value of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb)

GM Value of SARS-CoV-2- Specific Neutralizing Antibody (nAb)

Number of Participants with SARS-CoV-2 Infection Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein in Participants with Negative SARS-CoV-2 at Baseline, in the Absence of Any COVID-19 Symptoms

+2 more

Side effects data

From 2022 Phase 4 trial • 41 Patients • NCT04792567

24%

COVID-19

18%

Lymphopenia

18%

Injection site pain

12%

Pain in extremity

12%

Multiple sclerosis relapse

12%

Liver function test increased

Back pain

Flushing

VIth nerve paralysis

Escherichia urinary tract infection

Visual impairment

Fatigue

Injection site pustule

Rhinitis

Upper limb fracture

Myalgia

Dizziness

Headache

Menstrual disorder

Cough

Pyrexia

Urinary tract infection

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

~20920

mRNA-1273

2021

Completed Phase 4

~58750

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

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.