What side effects are associated with this type of intervention?

The most common side effects of mRNA COVID-19 vaccines, such as mRNA-1273.214 and mRNA-1273.815, include mild to moderate reactions like pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea. Rare but more serious side effects can include myocarditis, particularly in younger males, and severe allergic reactions. These vaccines have been shown to be generally safe and effective in eliciting an immune response against SARS-CoV-2.

What prior FDA approvals exist?

The FDA has approved several mRNA vaccines for the treatment of COVID-19, including the BNT162 vaccine developed by Pfizer/BioNTech and the mRNA-1273 vaccine developed by Moderna Inc. These vaccines encode the spike protein of SARS-CoV-2 to elicit an immune response. Both vaccines have shown around 95% clinical efficacy and have received emergency use authorizations for vaccination in the USA.

What other types of research exist?

Promising alternatives to mRNA-1273.214 and mRNA-1273.815 for COVID-19 treatment in 2024 include: 1) BNT162b2 (Pfizer-BioNTech), another mRNA vaccine with proven efficacy and safety. 2) NVX-CoV2373 (Novavax), a protein subunit vaccine that has shown strong immunogenicity and safety profiles. 3) AZD1222 (AstraZeneca), a viral vector vaccine with robust efficacy data. 4) Monoclonal antibody treatments, such as sotrovimab and casirivimab/imdevimab, which have been effective in treating COVID-19. 5) Oral antiviral medications like molnupiravir and nirmatrelvir/ritonavir (Paxlovid), which have shown promise in reducing the severity of COVID-19.

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Virus Vaccine

mRNA-1273.214 Vaccine for COVID-19 in Children

Phase 3

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

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

Must have

Participants with chronic diseases (asthma, diabetes mellitus, cystic fibrosis, HIV infection) must have stable disease status for at least 6 months prior to Screening Visit

Participant must be 2 years or older with a BMI at or above the 2nd percentile according to WHO Child Growth Standards, or less than 2 years with height and weight at or above the 2nd percentile

Must not have

Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to enrollment

Acutely ill or febrile 24 hours prior to or at the Screening Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests updated COVID-19 vaccines on young children. The vaccines use mRNA to teach the body to recognize and fight the virus. The study aims to ensure these vaccines are safe and effective for this age group.

Who is the study for?

Healthy children aged 6 months to less than 6 years, with normal growth standards, who have either not received a COVID-19 vaccine or had two doses of mRNA-1273 at least four months prior. Children with stable chronic diseases can join. Those acutely ill, febrile, or previously infected with SARS-CoV-2 within the last 90 days are excluded.

What is being tested?

The trial is testing the safety and immune response to the mRNA-1273.214 COVID-19 vaccine in young children. It involves two parts: one for those who haven't been vaccinated and another for those previously given two doses of mRNA-1273 as a primary series.

What are the potential side effects?

Possible side effects include typical reactions at the injection site like pain and swelling, fever, fatigue, headache, muscle pain, chills and nausea. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

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

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My chronic condition (like asthma or diabetes) has been stable for at least 6 months.

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I am 2 years or older with a healthy weight, or under 2 with proper height and weight.

Exclusion Criteria

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

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I haven't taken immune-suppressing drugs for more than 2 weeks in the last 6 months.

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I have not been seriously ill or had a fever in the last 24 hours.

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I have received a COVID-19 vaccine that is not mRNA-1273.

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I haven't had any vaccines 14 days before or plan to within 14 days after the study vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 & 3 trial • 3548 Patients • NCT05249829

COVID-19

Headache

Upper respiratory tract infection

Nausea

Seasonal allergy

Asymptomatic COVID-19

Nasopharyngitis

Arthralgia

Pneumonia

Cough

Dyspnoea

Fatigue

Diarrhoea

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: mRNA-1273

Part 1: mRNA-1273.529

Part 2: mRNA-1273

Part 2: mRNA-1273.214

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Group I: mRNA-1273.815 (Part 4)Experimental Treatment1 Intervention

Participants in Part 4 Cohort A will receive a single IM injection of mRNA-1273.815 vaccine on Day 1. Participants in Part 4 Cohort B will receive IM injections of mRNA-1273.815 vaccine on Day 1 and Day 29.

Group II: mRNA-1273.815 (Part 3)Experimental Treatment1 Intervention

Participants who have previously been vaccinated with an authorized/approved COVID-19 vaccine, will receive a single IM BD of mRNA-1273.815 vaccine on BD Day 1, at least 4 months after the last dose of a COVID-19 vaccine.

Group III: mRNA-1273.214 (Part 2)Experimental Treatment1 Intervention

Participants who have previously been vaccinated with a mRNA-1273 primary series, will receive a single IM BD of mRNA-1273.214 vaccine at least 4 months after completion of the mRNA-1273 primary series.

Group IV: mRNA-1273.214 (Part 1)Experimental Treatment1 Intervention

Participants who have not been previously vaccinated against SARS-CoV-2, will receive 2 intramuscular (IM) injections of mRNA-1273.214 vaccine on Day 1 and Day 29.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moderna COVID-19 Vaccine

FDA approved

mRNA-1273.815

2021

Completed Phase 3

~5410

0 / 6Eligibility 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 most common treatments for COVID-19 include antiviral drugs like remdesivir, which inhibits viral replication, and immunomodulators like dexamethasone, which reduce inflammation. mRNA vaccines, such as mRNA-1273.214 and mRNA-1273.815, work by encoding the spike protein of SARS-CoV-2, prompting the body to produce an immune response. This mechanism is crucial as it prepares the immune system to recognize and combat the virus effectively, reducing the severity of the disease and preventing infection. These treatments are vital for COVID-19 patients as they target different aspects of the virus's life cycle and the body's response, offering a multi-faceted approach to managing and preventing the disease.

Prevalence and outcome of COVID-19 among Iranian celiac patients.Current Therapeutics for COVID-19, What We Know about the Molecular Mechanism and Efficacy of Treatments for This Novel Virus.Antimicrobial peptides: features, applications and the potential use against covid-19.