mRNA-1273

A COVID-19 mRNA vaccine.

Phase of research

Emergency use authorization

How it helps

Vaccine

Drug status

Experimental

22
Supporting references
0
Contradictory references
34
Clinical trials

General information

mRNA-1273 is a COVID-19 vaccine developed by Moderna/NIAID. It is an LNP-encapsulated mRNA type of candidate vaccine. It is based on the RNA platform, which is also used for multiple non-COVID-19 candidates. This COVID-19 vaccine has completed Phase II of clinical evaluation. Preliminary reports show that the mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. Phase III clinical trial is underway. On November 16, 2020, Moderna reported that its RNA-based vaccine is more than 94% effective at preventing COVID-19, on the basis of an analysis of 95 cases in its ongoing phase III efficacy trial. mRNA-1273 has been found to elicit a durable immune response. The vaccine has been granted an emergency use authorization by the FDA on December 18, 2020, for use in individuals 18 years of age and older. On December 23, 2020, the Moderna COVID-19 vaccine received conditional authorization in Canada. On January 4, 2021, the vaccine received authorization in Israel. On January 6, 2021, the Moderna COVID-19 vaccine was granted conditional marketing authorization by the European Commission, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. On January 8, 2021, the Moderna vaccine received temporary authorization in the UK. On January 12, 2021, the vaccine was authorized in Switzerland. 

On May 5, 2021, Moderna announced positive initial booster data against SARS-CoV-2 variants of concern. A single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants. Booster dose of mRNA-1273.351, a strain-matched candidate, achieved higher titers against B.1.351 than a booster dose of mRNA-1273. mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated. Evaluation of a multivalent vaccine booster candidate, mRNA-1273.211, is ongoing; data is expected shortly.


Marketed as

SPIKEVAX


Supporting references

Link Tested on Impact factor Notes Publication date DB entry date
Exponential increase in neutralizing and spike specific antibodies following vaccination of COVID‐19 convalescent plasma donors
Spike protein RNA Case series Mixed substance
Vaccinated convalescent COVID-19 subjects. 2.80

Analysis pooled with

Apr/08/2021 May/03/2021
Neutralization of SARS-CoV-2 Variants B.1.429 and B.1.351
Spike protein RNA Protein factor Mixed substance Cohort study
Sera of vaccinated individuals; SARS-CoV-2 Spike pseudovirus (B.1.429 and B.1.351) 74.70

Sera from vaccinated individuals displayed only a modest decrease in neutralization capacity against SARS-CoV-2 Spike-psudotyped virus corresponding to the B.1.429 strain (“California”). The magnitude of decrease of neutralization titres against B.1.351 strain, however, was of a greater concern.

Apr/07/2021 Apr/24/2021
SARS-CoV-2 mRNA vaccines induce broad CD4+ T cell responses that recognize SARS-CoV-2 variants and HCoV-NL63
RNA Mixed substance Cohort study
Peripheral blood mononuclear cells from vaccinated individuals 11.86

Vaccination elicited CD4+ T cell response which might effectively recognize some of the common SARS-CoV-2 variants.

Apr/06/2021 Apr/24/2021
Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19
RNA Phase I clinical trial Mixed substance Cohort study
Sera from vaccinated subjects (18+ years of age) 74.70

209 days after the administration of the second vaccine dose, antibody activity remained high in all age groups (although the titres were lower in the higher-age groups). Based on the model used, the antibody binding activity half-life was 43 or 109 days, neutralizing antibody activity half-life against pseudovirus infection was 69 or 173 days, and neutralizing antibody activity half-life against live virus infection was 68 or 202 days. The model suggesting longer half-lives assumes that decay rates decrease over time. Sample size: 33 donors. Dosage: Two doses of 100 μg.

Apr/06/2021 Apr/24/2021
Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers - Eight U.S. Locations…
Spike protein RNA Mixed substance Cohort study
Frontline/healthcare workers 13.61

(Analyses pooled with

Apr/02/2021 Apr/05/2021
Reactogenicity, safety and antibody response, after one and two doses of mRNA-1273 in seronegative and seropositive healthcare workers
Spike protein RNA Mixed substance Cohort study
Seropositive or seronegative subjects 4.84

A single dose administration in most of the subjects who were seropositive prior to the vaccination elicited presumably sufficient immune reaction. Adverse reactions were more frequent in this cohort compared to infection-naïve subjects. Generally, adverse reactions were more frequent after the second dose administration. Sample size: 151 seronegative + 55 seropositive. Dosage: One or two doses.


Mar/31/2021 Apr/16/2021
mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection
Spike protein RNA In vitro Mixed substance Cohort study
Sera of (non)vaccinated convalescent and vaccinated naïve donors; SARS-CoV-2 Spike Wuhan-Hu-1 and B.1.31 pseudoviruses 41.85

(Data pooled with those for

Mar/25/2021 Mar/31/2021
COVID-19 vaccine response in pregnant and lactating women: a cohort study
RNA Cohort study
pregnant and lactating women 6.50 2019

COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in non-pregnant women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

Mar/25/2021 Apr/01/2021
Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort
Spike protein RNA Non-randomized controlled open trial Mixed substance
Patients with chronic inflammatory conditions and immunosuppressive therapy 16.10

A pooled analysis with

Mar/24/2021 Mar/30/2021
Antibody response to a single dose of SARS-CoV-2 mRNA vaccine in patients with rheumatic and musculoskeletal diseases
Spike protein RNA Mixed substance Cohort study
SARS-CoV-2-naïve patients with rheumatic and musculoskeletal diseases 16.10

(Analyses pooled with

Mar/23/2021 Apr/03/2021
Early Evidence of the Effect of SARS-CoV-2 Vaccine at One Medical Center
Spike protein RNA Mixed substance Cohort study
Frontline healthcare workers 74.70

(Data pooled with

Mar/23/2021 Apr/03/2021
Infection- and vaccine-induced antibody binding and neutralization of the B.1.351 SARS-CoV-2 variant
RNA In vitro Mixed substance Cohort study
in vitro binding assay; Vero E6 cells; sera of vaccinated individuals; SARS-CoV-2 strains EHC-083E (B.1) and B.1.351 15.92

Although 3.8-fold decrease in neutralizing titres against B.1.351 compared to B.1 was observed in the sera of vaccinated individuals, the sera were still capable to neutralize the SARS-CoV-2 variant in vitro.

Mar/20/2021 Apr/13/2021
Neutralizing Antibodies Against SARS-CoV-2 Variants After Infection and Vaccination
Spike protein RNA In vitro Mixed substance
mRNA-1273-vaccinated patients’ sera; SARS-CoV-2 strains nCoV/USA_WA1/2020, EHC-083E, B.1.1.7 and a N501Y carrying strain. 45.54

Sera of vaccinated subjects (14-days post second dose) displayed titres of SARS-CoV-2-neutralizing antibodies which should be protective against the infection; although, the neutralizing capacity against assayed emergent strains (e. g. B.1.1.7) was significantly weaker compared to an earlier variant (nCoV/USA_WA1/2020).

Mar/19/2021 Mar/26/2021
Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity
RNA In vitro Mixed substance
in vitro binding assay; sera of vaccinated individuals; 293T-ACE2 cells; SARS-CoV-2 Spike pseudovirus (various variants) 38.64

SARS-CoV-2 Spike protein of some strains, especially of B.1.351 (“South Africa”), seems to be several-fold more resistant to neutralization by antibodies from vaccinated subjects compared to the wild type virus. This is especially true for individuals with a single dose vaccination without prior SARS-CoV-2 infection or exposure. The sera of subjects vaccinated with two doses, or of those with previous virus exposure, seem to retain neutralizing capacity to some extent, however.

Mar/12/2021 Mar/26/2021
SARS-CoV-2 variant B.1.1.7 is susceptible to neutralizing antibodies elicited by ancestral spike vaccines
Spike protein RNA Protein factor Mixed substance Cohort study
Sera of vaccinated or convalescent adults; HEK293T/17 cells; SARS-CoV-2 Spike pseudovirus 15.92

Although the capacity of sera of vaccinated subjects and convalescent individuals to neutralize SARS-CoV-2 B.1.1.7 variant Spike pseudovirus decreased, the decrease was only modest (2.1-fold and 1.5-fold, respectively); therefore, SARS-CoV-2 variant B.1.1.7 should not be of a major concern for mRNA-1273 recipients and convalescent individuals.

Mar/05/2021 Mar/22/2021
Binding and Neutralization Antibody Titers After a Single Vaccine Dose in Health Care Workers Previously Infected With SARS-CoV-2
RNA Mixed substance Cohort study
Sera of health-care workers vaccinated with a single dose 45.54

At days 7 or 14 after a single-dose vaccination, the health-care workers with prior SARS-CoV-2 infection developed higher anti-Spike antibodies and more potent live virus neutralizing capacity compared to the non-infected subjects. Sample size: 13 with evidence of previous symptomatic SARS-CoV-2 infection + 10 with evidence of previous asymptomatic SARS-CoV-2 infection + 7 seronegative. Data were pooled with

Mar/01/2021 Mar/16/2021
mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants
RNA Cryo-EM In vitro Mixed substance
sera of immunized volunteers (the source of antibody-producing B cells); in vitro binding assay; cryo-EM; hACE2-293T cells; HT1080ACE2.cl14 cells; SARS-CoV-2 variant Spike-pseudotyped viruses 42.78

Some of the antibodies identified in the B cells from immunized volunteers which bound SARS-CoV-2 Spike S or BRD domain of the original SARS-CoV-2 were found to have a decreased or no neutralizing activity against some of the emerging Spike variants (E484K or N501Y or the K417N:E484K:N501Y combination). Overall, the plasma neutralizing activity against these variants was present but decreased.

Feb/10/2021 Mar/01/2021
A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
RNA Phase II clinical trial Randomized controlled double-blind trial Mixed substance
Healthy adults 3.14

The adverse reactions after vaccine administration were mostly mild or moderate and temporary. SARS-CoV-2-neutralizing antibodies were elicited in titres higher than those observed in sera of convalescent patients (with seroconversion in 28 days after the first dose in most of the subjects). Sample size: For immunogenicity analyses: ≥55 years of age: 94 (placebo subgroup) + 95 (50μg doses subgroup) + 94 (100 μg doses subgroup); 18–<55 years of age: 92 (placebo group) + 90 (50μg doses group) + 95 (100 μg doses group). For safety analyses: 100 subjects in each of the subgroups. Dosing: Two 50 μg or two 100 μg doses, 28 days apart. Primary outcomes: Safety, reactogenicity, and immunogenicity.



Feb/09/2021 Mar/18/2021
Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination
RNA Mixed substance Cohort study
Healthy adults 74.70

Although slightly declining (as expected), the vaccinated healthy adults in all age groups produced high titres of binding and neutralizing antibodies (targeted at SARS-CoV-2 Spike RBD) at day 119 post first immunization. The antibody titres were high enough to manifest potent live- and pseudovirus neutralization in vitro. No serious adverse effects were observed.

Dec/03/2020 Dec/09/2020
SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen Preparedness
RNA Preprint
mice 42.78

mRNA elicited potent pseudovirus neutralizing activity and S-specific binding antibodies production in mice; Efficient agains both the D614 type and the D614G mutant.

Aug/05/2020 Jun/12/2020
An mRNA Vaccine against SARS-CoV-2 - Preliminary Report healthy adults 74.70

induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified

Jul/14/2020 Aug/11/2020
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020 in vitro Mar/26/2020 Apr/03/2020

Clinical trials

ID Title Status Phase Start date Completion date
NCT05075538 Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 Not yet recruiting Phase 4 Nov/01/2021 Feb/01/2024
NCT05047770 A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine Recruiting Phase 3 Oct/07/2021 Jul/21/2022
NCT05030974 RECOVAC Booster Vaccination Study Not yet recruiting Phase 4 Oct/01/2021 Jan/01/2023
NCT05079633 A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV190 in Adults Recruiting Phase 4 Sep/30/2021 Jun/01/2022
NCT04978038 Third Dose of COVID-19 Vaccine in LTCF Residents Not yet recruiting Phase 4 Sep/15/2021 Apr/15/2022
NCT05054218 COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients Recruiting Sep/10/2021 May/01/2023
NCT04958304 Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study Recruiting Sep/01/2021 Jan/06/2024
NCT05048940 Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against SARS-CoV-2 in Patients Undergoing Solid Organ Transplantation. Not yet recruiting Phase 3 Sep/01/2021 Jan/01/2023
NCT04969250 Vaccination for Recovered Inpatients With COVID-19 (VATICO) Recruiting Phase 4 Aug/25/2021 Jul/01/2022
NCT05000216 COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders Recruiting Phase 2 Aug/13/2021 Dec/01/2022
NCT04969263 COVID-19 Protection After Transplant Pilot Study Active, not recruiting Phase 2 Aug/10/2021 Oct/01/2022
NCT04854980 Serologic Response to the SARS-CoV-2 (COVID-19) mRNA-1273 Vaccine in Select Subsets of Oncology Patients Recruiting Aug/03/2021 Jul/31/2022
NCT04930770 Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination Not yet recruiting Phase 2 Aug/01/2021 Mar/01/2022
NCT04952402 SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine Recruiting Phase 4 Jul/16/2021 Jun/01/2023
NCT04958954 Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States Not yet recruiting Jul/06/2021 Jun/30/2023
NCT04889209 Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines Recruiting Phase 1|Phase 2 May/28/2021 Dec/01/2022
NCT04927065 A Study to Evaluate the Immunogenicity and Safety of mRNA-1273.211 Vaccine for COVID-19 Variants Active, not recruiting Phase 2|Phase 3 May/28/2021 Sep/30/2022
NCT04885907 Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients Active, not recruiting Phase 4 May/25/2021 Aug/30/2021
NCT04894435 Mix and Match of the Second COVID-19 Vaccine Dose for Safety and Immunogenicity Recruiting Phase 2 May/20/2021 Mar/01/2023
NCT04848441 Risk of COVID-19 Infection After Vaccination Not yet recruiting May/01/2021 Aug/01/2021
NCT04852978 COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers Recruiting Phase 2 Apr/29/2021 Nov/22/2022
NCT04847050 A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy Recruiting Phase 2 Apr/28/2021 Feb/25/2023
NCT04805125 Immunocompromised Swiss Cohorts Based Trial Platform Active, not recruiting Phase 3 Apr/19/2021 Jul/01/2022
NCT04860297 A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants Recruiting Phase 3 Apr/16/2021 Mar/31/2023
NCT04834869 COVID-19 Vaccines Safety Tracking (CoVaST) Recruiting Apr/01/2021 Jan/31/2022
NCT04785144 Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults Active, not recruiting Phase 1 Mar/29/2021 Aug/31/2022
NCT04796896 A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age Recruiting Phase 2|Phase 3 Mar/15/2021 Jun/12/2023
NCT04813796 A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 Active, not recruiting Phase 1 Mar/11/2021 Apr/13/2022
NCT04748471 Immunogenecity and Safety of VaccinemRNA-1273 in Elderly Volunteers (Over 65 y) Compared to Younger Ones (18-45y) Not yet recruiting Phase 2 Feb/10/2021 Jan/25/2023
NCT04715438 Vaccination Against COVID-19 in Cancer Active, not recruiting Not Applicable Jan/08/2021 Apr/01/2023
NCT04649151 A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19 Active, not recruiting Phase 2|Phase 3 Dec/09/2020 Jun/30/2022
NCT04470427 A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 Active, not recruiting Phase 3 Jul/27/2020 Oct/27/2022
NCT04405076 Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older Active, not recruiting Phase 2 May/29/2020 Oct/31/2021
NCT04283461 Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) Active, not recruiting Phase 1 Mar/16/2020 Nov/22/2022