What side effects are associated with this type of intervention?

Common side effects of mRNA COVID-19 vaccines, such as mRNA-1273 and BNT162b2, include local reactions at the injection site (pain, redness, swelling) and systemic reactions (fever, fatigue, headache, muscle pain, chills). Severe allergic reactions like anaphylaxis are rare. Other rare side effects include myocarditis and pericarditis, particularly in younger males.

What other types of research exist?

Promising alternatives to mRNA-1273.214 for COVID-19 patients 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 immune responses. 3) AZD1222 (AstraZeneca), a viral vector vaccine with widespread use and effectiveness. 4) Therapeutic monoclonal antibodies, which can provide immediate passive immunity. 5) Oral antiviral medications like Paxlovid (nirmatrelvir/ritonavir) that reduce viral replication and severity of illness.

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Virus Vaccine

mRNA-1273.214 Vaccine for Infant COVID-19 (BabyCOVE Trial)

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

The most common treatments for COVID-19 include mRNA vaccines, antiviral drugs, and monoclonal antibodies. mRNA vaccines, such as mRNA-1273.214, work by instructing cells to produce a protein that triggers an immune response against SARS-CoV-2, helping the body recognize and fight the virus more effectively. Antiviral drugs inhibit the replication of the virus within the host cells, reducing the viral load and severity of the disease. Monoclonal antibodies are lab-made proteins that mimic the immune system's ability to fight off harmful pathogens, providing immediate but temporary immunity. These treatments are crucial for COVID-19 patients as they can prevent severe illness, reduce hospitalizations, and decrease the spread of the virus.

Q: What prior FDA approvals exist?

The FDA has granted Emergency Use Authorizations (EUAs) for several mRNA vaccines for the treatment of COVID-19. Notably, the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine have been approved. These vaccines work by instructing cells to produce a protein that triggers an immune response against SARS-CoV-2. Additionally, the FDA has authorized bivalent booster doses for these vaccines, which include components targeting both the original virus strain and the Omicron BA.4/BA.5 variants.

Phase 2

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will test a new COVID-19 vaccine in young infants to ensure it is safe and effective. The vaccine works by using mRNA to teach the body to fight the virus.

Who is the study for?

This trial is for healthy infants aged between 2 and <6 months who were born at or after 34 weeks gestation, with a minimum birth weight of 2.5 kg. They should not have received COVID-19 prophylaxis, have no known allergies to vaccine components, and must not be acutely ill or febrile before the study.

What is being tested?

The trial tests the safety and effectiveness of mRNA-1273.214 SARS-CoV-2 vaccine in infants compared to a placebo. Infants will receive either the vaccine or placebo to determine how well it works and monitor any reactions.

What are the potential side effects?

Possible side effects include typical reactions seen with vaccines such as pain at injection site, fever, fatigue, irritability, loss of appetite, and sleepiness. Severe allergic reactions are rare but possible.

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

Nasopharyngitis

Cough

Nausea

Fatigue

Pneumonia

Asymptomatic COVID-19

Dyspnoea

Arthralgia

Seasonal allergy

Oropharyngeal pain

Diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: mRNA-1273

Part 2: mRNA-1273

Part 2: mRNA-1273.214

Part 1: mRNA-1273.529

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: mRNA-1273.214Experimental Treatment1 Intervention

Participants will receive 2 doses of mRNA-1273.214 by IM injection approximately 8 weeks apart (Day 1 and Day 57).

Group II: Part 1: mRNA-1273.214 Dose BExperimental Treatment1 Intervention

Participants will receive 2 doses of mRNA-1273.214 Dose B by IM injection approximately 8 weeks apart (Day 1 and Day 57).

Group III: Part 1: mRNA-1273.214 Dose AExperimental Treatment1 Intervention

Participants will receive 2 doses of mRNA-1273.214 Dose A by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).

Group IV: Part 2: PlaceboPlacebo Group1 Intervention

Participants will receive 2 doses of placebo by IM injection approximately 8 weeks apart (Day 1 and Day 57).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1273.214

2021

Completed Phase 3

~20910

Do I qualify?Apply below to find out

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 mRNA vaccines, antiviral drugs, and monoclonal antibodies. mRNA vaccines, such as mRNA-1273.214, work by instructing cells to produce a protein that triggers an immune response against SARS-CoV-2, helping the body recognize and fight the virus more effectively. Antiviral drugs inhibit the replication of the virus within the host cells, reducing the viral load and severity of the disease. Monoclonal antibodies are lab-made proteins that mimic the immune system's ability to fight off harmful pathogens, providing immediate but temporary immunity. These treatments are crucial for COVID-19 patients as they can prevent severe illness, reduce hospitalizations, and decrease the spread of the virus.

TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.Investigation of immune cells on elimination of pulmonary-Infected COVID-19 and important role of innate immunity, phagocytes.Reaction Cycles of Halogen Species in the Immune Defense: Implications for Human Health and Diseases and the Pathology and Treatment of COVID-19.