Lancet Infectious Diseases
Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial
In this ongoing, randomized, observer-blind, active-controlled, phase 3 trial, participants ≥ 12 years of age were assigned to receive 1 dose of original + omicron BA.4/BA.5 bivalent mRNA-1283 (10 μg) or mRNA-1273 (50 μg). Results suggested improved vaccine efficacy of mRNA-1283 versus mRNA-1273, particularly in adults >65 years, and higher nAb responses against omicron BA.4/BA.5 and SARS-CoV-2 D614G at day 29. mRNA-1283 was well tolerated with no new safety concerns (July 2025)

JAMA
Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial
This article reports safety, reactogenicity, and immunogenicity findings of a phase 3 active-controlled trial of mRNA-1083, a multicomponent mRNA vaccine against seasonal influenza and SARS-CoV-2, in adults aged 50 years or older (May 2025)

Frontiers in Immunology
mRNA-1273 COVID-19 vaccine induces CD4+ T-cell responses among solid organ transplant recipients
This article reports findings from the P304 trial (NCT04860297) in which cell-mediated immunity of mRNA-1273 was evaluated as an exploratory objective in a subset of adult solid organ transplant recipients and healthy participants who received the mRNA-1273 primary series or an additional dose. Exploratory endpoints included magnitude, phenotype, and percentage of cytokine-producing spike protein-specific T cells as measured by flow cytometry (April 2025)

Advances in Therapy
Comparative Effectiveness of mRNA-1273 and BNT162b2 COVID-19 Vaccines Among Adults with Underlying Medical Conditions
Systematic Literature Review and Pairwise Meta-Analysis Using GRADE: This systematic literature review and pairwise meta-analysis evaluated the comparative effectiveness of mRNA-1273 versus BNT162b in patients with at least one underlying medical condition at high risk for severe COVID-19 (March 2025)

Current Medical Research and Opinion
Indirect comparison of the relative vaccine effectiveness of mRNA-1283 vs. BNT162b2 vaccines against symptomatic COVID-19 among US adults
(February 2025)

Vaccines (Basel)
Safety, Tolerability, and Immunogenicity of the Pneumococcal Vaccines PPSV23 or PCV15 Co-Administered with a Booster Dose of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adults ≥50 Years of Age
(February 2025)

Human Vaccines & Immunotherapeutics
Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents
This study evaluated the safety, immunogenicity, and inferred effectiveness of a homologous booster dose of mRNA-1273 (50 μg) during the peak early omicron period in January 2022 in healthy adolescents in the Part 1C–1 of the TeenCOVE trial. Furthermore, the immunogenicity of a single mRNA-1273 booster dose in adolescents with and without prior SARS-CoV-2 infection was also evaluated (January 2025)

2024

Infectious Diseases and Therapy
Evaluating the Effectiveness of mRNA-1273.815 Against COVID-19 Hospitalization Among Adults Aged ≥ 18 Years in the United States
This observational, matched cohort study used medical and pharmacy claims data from HealthVerity comparing adults vaccinated with mRNA-1273.815 (between September 12-December 31, 2023, and followed through January 26, 2024) with matched with individuals unvaccinated with any 2023–2024 COVID-19 vaccine. mRNA-1273.815 significantly protected against COVID-19-related hospitalizations and medically attended COVID-19 across diverse adult populations and demonstrated durability of the effect (December 2024)

Lancet Infectious Diseases
Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older
An observer-blinded, placebo-controlled, randomised, phase 3 trial (November 2024)

Open Forum Infectious Diseases
Effectiveness of the 2023-2024 Omicron XBB.1.5-containing mRNA COVID-19 vaccine (mRNA-1273.815) in preventing COVID-19-related hospitalizations and medical encounters among adults in the United States
This study evaluated vaccine effectiveness of the mRNA-1273.815 vaccine against COVID-19-related hospitalizations and any medically attended COVID-19 in adults aged ≥18 years (November 2024)

Expert Review of Vaccines
A descriptive review on the real-world impact of Moderna, Inc. COVID-19 vaccines
This descriptive review discusses the benefits and risks associated with the marketed Moderna, Inc. mRNA-based COVID-19 vaccines, with an emphasis on their real-world effectiveness and safety profiles in various age groups. Adverse events of interest and potential benefits of vaccination are reviewed, including the reduced risk for severe COVID-19 and associated long-term health outcomes, reduced economic and societal costs, and reduced risk for SARS-CoV-2 transmission (October 2024)

Expert Review of Vaccines
A review of the immunogenicity and safety of booster doses of omicron variant-containing mRNA-1273 COVID-19 vaccines in adults and children
This review detailed comprehensively the available evidence (published through July 2024) from ongoing clinical trials on omicron variant-containing mRNA-1273 vaccines administered as additional doses in previously vaccinated target demographics (September 2024)

Clinical Infectious Diseases
Safety and Immunogenicity of an mRNA-1273 Booster in Children
This study evaluated the safety, immunogenicity, and efficacy of an mRNA-1273 booster dose administered 6 months or more after primary series in children aged 6 months–11 years. The results demonstrated that the booster dose safety profile was generally consistent with that of the primary series in children and no new safety concerns were identified; the booster dose elicited robust neutralizing antibody responses and met prespecified noninferiority success criteria (August 2024)

Nature Communications
Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases
This study presented the final results of the longer-term safety and efficacy data of the mRNA-1273 (100-μg) primary vaccination series plus a 50-μg booster dose administered in Fall 2021 (August 2024)

eClinicalMedicine
Safety and durability of mRNA-1273–induced SARS-CoV-2 immune responses in adolescents: results from the phase 2/3 TeenCOVE trial
This study reported long-term safety, immunogenicity, and COVID-19 incidence following a 2-dose mRNA-1273 100-μg primary series, and immunogenicity following a single dose of mRNA-1273 50 μg in vaccine-naïve adolescents (July 2024)

IDT
Immunogenicity of mRNA‑1273 and BNT162b2 in Immunocompromised Patients: Systematic Review and Meta‑analysis Using GRADE
This systematic literature review and pairwise meta-analysis compared seroconversion rates, total and neutralizing anti-spike antibody titers, and cellular immunity levels in immunocompromised individuals after vaccination with 2 or 3 doses of mRNA-1273 or BNT162b2. The GRADE framework was used to evaluate evidence reported in this meta-analysis (May 2024)

Hum Vaccin Immunother
Effectiveness and durability of mRNA-1273 BA.4/BA.5 bivalent vaccine (mRNA-1273.222) against SARS-CoV-2 BA.4/BA.5 and XBB sublineages
This study evaluated the effectiveness of mRNA-1273 bivalent COVID-19 vaccine against sequencing confirmed BA.4/BA.5-r and XBB-related sublineages in a large, socio-demographically diverse population (Kaiser Permanente Southern California) (April 2024)

Clinical Infectious Diseases
COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials
This study reported COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled efficacy trials (April 2024)

The Journal of Infectious Diseases
Safety and Immunogenicity of the mRNA-1273 Coronavirus Disease 2019 Vaccine in Solid Organ Transplant Recipients
This study reported interim findings from the phase 3b trial assessing the safety and immunogenicity of mRNA-1273 administered as a 3-dose primary series and an additional dose in adult solid organ transplant recipients aged ≥18 years (April 2024)

Open Forum Infectious Diseases
Global Safety Assessment of Adverse Events of Special Interest Following 2 Years of Use and 772 Million Administered Doses of mRNA-1273
This article reviewed the safety profile of the original mRNA-1273 vaccine following 2 years of use (>772 million administered doses), primarily focusing upon predefined safety topics (ie, adverse events of special interest) proposed in advance of COVID-19 vaccine use (March 2024)

Infectious Diseases and Therapy
Comparative effectiveness of mRNA-1273 and BNT162b2 COVID-19 vaccines among older adults: Systematic literature review and meta-analysis using the GRADE framework
This systematic literature review and meta-analysis assessed the comparative effectiveness of mRNA-1273 versus BNT162b2 in older adults aged ≥50 years (March 2024)

Hum Vaccin Immunother
No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial
This study assessed the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV) (March 2024)

2023

Vaccines
Comparative Effectiveness of Bivalent (Original/Omicron BA.4/BA.5) COVID-19 Vaccines in Adults
This retrospective cohort study evaluated data from a large nationwide dataset to estimate the relative vaccine efficacy of the mRNA-1273.222 variant-containing vaccine with BNT162b2 bivalent vaccine administered for the prevention of COVID-19-related hospitalizations and outpatient visits in adults in the United States (November 2023)

Human Vaccines & Immunotherapeutics
Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults
This study reported on the preliminary safety, reactogenicity, and immunogenicity data for mRNA-1283 administered to adults aged 18-55 years as part of the phase 1 clinical trial (April 2023)

Nature Communications
Effectiveness of mRNA-1273 vaccination against SARS-CoV-2 omicron subvariants BA.1, BA.2, BA.2.12.1, BA.4, and BA.5
This test-negative case-control study evaluated the effectiveness of mRNA-1273 against SARS-CoV-2 infection and COVID-19 related hospitalizations for omicron subvariants, including BA.4 and BA.5, in the United States Kaiser Permanente Southern California healthcare system (January 2023)

2022

NEJM
Neutralization of Omicron Subvariant BA.2.75 after Bivalent Vaccination
This study evaluated neutralizing titers against BA.2.75 and cross-neutralization potential against multiple omicron variants following a booster dose of mRNA-1273.214 in adults (November 2022)

NEJM
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age
This study reports on the safety, reactogenicity, immunogenicity, and efficacy of mRNA-1273 as part of the phase 2-3 KidCOVE trial in children aged 6 months to 5 years (October 2022)

NEJM
A Bivalent Omicron-containing Booster Vaccine Against Covid-19
This study evaluated safety and immunogenicity of an omicron-containing bivalent booster (mRNA-1273.214; 50-μg) in adults (September 2022)

Clinical Infectious Diseases
Analysis of Myocarditis Among 252 Million mRNA-1273 Recipients Worldwide
This study assesed the cumulative risk of myocarditis/myopericarditis among mRNA-1273 recipients from December 2020 to February 2022 using Moderna's global safety database. Rates for the overall population of mRNA recipients were not higher than expected. Rates for males aged 18-24 were higher than expected (June 2022)

NEJM
Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age
This study reports on the interim safety, immunogenicity, and efficacy of the phase 2-3 KidCOVE trial administering 2 doses of mRNA-1273 (50 µg, 28 days apart) in children aged 6-11 years (May 2022)

Nature Medicine
Immune response to SARS-CoV-2 after a booster of mRNA-1273
an open-label phase 2 trial: This study reports immunogenicity, safety, reactogenicity, and antobody persistence in participants who received a single 50 µg booster dose (209 days after completion of the primary series) during the phase 2 mRNA-1273 trial (open-label, interventional phase) (March 2022)

Nature Medicine
Effectiveness of mRNA-1273 against SARS-CoV-2 Omicron and Delta variants
This study reports the vaccine effectiveness of mRNA-1273 against infection and hospitalization with omicron and delta within the Kaiser Permanente Southern California (KPSC) healthcare system (February 2022)

NEJM
SARS-CoV-2 Omicron Variant Neutralization after mRNA-1273 Booster Vaccination
This study evaluated omicron neutralization by serum samples obtained from participants (COVE trials) who had received 2 doses of mRNA-1273 (100 µg), a booster dose of the mRNA-1273 (50 or 100 μg dose), the bivalent mRNA-1273.211 vaccine ( 1:1 mix of mRNA-1273 and beta specific construct; total dose of either 50 or 100 μg), or the bivalent mRNA-1273.213 vaccine (1:1 mix of beta and delta constructs; 100 μg) (January 2022)

2021

NEJM
Phase 3 Trial of mRNA-1273 during the Delta-Variant Surge
This is exploratory analysis evaluated COVID-19 cases identified between 01 July 2021 and 27 Aug 2021 (when delta variant surged in the United States) in the ongoing COVE trial. Incidence rates of COVID-19 were lower during the months when delta was the dominant variant among COVE participants vaccinated more recently (Dec 2020 to Apr 2021) compared with those vaccinated earlier (Jul-Dec 2020), suggesting potential waning of immunity (November 2021)

The Lancet Regional Health Americas
Real-world effectiveness of the mRNA-1273 vaccine against COVID-19: Interim results from a prospective observational cohort study
This real-world study measured the effectiveness of 2 doses of mRNA-1273 against asymptomatic infection, COVID-19 diagnosis, and severe outcomes in groups of 350,000 vaccinated and unvaccinated matched individuals. The study provided reassuring evidence of VE of 87·4% against COVID-19 diagnosis, 95·8% against COVID-19 hospitalization, and 97·9% against COVID-19 hospital death (November 2021)

NEJM
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase
This study reports the final analysis of efficacy and safety data from the observer-blinded phase of the phase 3 trial of mRNA-1273 (COVE study). At 5 months after vaccination, mRNA-1273 had an acceptable safety profile, remained efficacious in preventing COVID-19 illness (VE 93.2%) and severe disease (VE 98.2%), and had lower protection against asymptomatic infection (September 2021)

NEJM
Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents
The TeenCOVE study confirmed the safety and non-inferiority of mRNA-1273 in adolescents (12-17 years) compared with participants aged 18-25 who were enrolled in the phase 3 COVE study (August 2021)

NEJM
Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19
This study showed persistence of neutralizing antibodies 6 moths after 2nd injection in patients from phase 1 mRNA-1273 study (June 2021)

NEJM
Serum Neutralizing Activity Elicited by mRNA-1273 Vaccine — Preliminary Report
This study evaluated the neutralizing activity of sera from participants in phase 1 mRNA-1273 trial against emerging variants (March 2021)

Vaccine
A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
This phase 2 clinical study of mRNA-1273 reports the safety and immunogenicity results of participants aged 18 years and older who received 50 µg and 100 µg given as a two-dose regimen. There were significant immune responses to SARS-CoV-2 with an acceptable safety profile and immunogenicity (February 2021)

2020

NEJM
Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Phase 1 clinical study of mRNA-1273 vaccine against SARS-Cov-2 showed a higher level of neutralizing antibodies with a 100-µg dose in healthy older adults with an acceptable safety profile (September 2020)

NEJM
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
This phase 3 clinical study of mRNA-1273 vaccine reports interim safety and primary efficacy results in participants who received the 100 µg two-dose regimen of the vaccine given 28 days apart; mRNA-1273 was well-tolerated and demonstrated vaccine efficacy of 94.1% at preventing symptomatic COVID-19 (September 2020)