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On the same day, Moderna announced that a study of the stability of mRNA-1273 had found that the vaccine remained stable for up to 30 days at standard refrigeration temperatures of 2 to 8 degrees Celsius.
means it can be stored in a regular refrigerator and will facilitate the storage, transport and use of vaccines.
mRNA-1273 is an mRNA vaccine that encodes the pre-integration stable form of the new coronavirus hedgehog protein, developed by Moderna and researchers from the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
October 22, phase 3 clinical trial COVE of mRNA-1273 completed the group of 30,000 subjects in the United States.
the main endpoint of this randomized double-blind, placebo-controlled Phase 3 clinical trial was the prevention of symptomatic COVID-19 disease.
secondary endpoints include the prevention of severe COVID-19 diseases and the prevention of new coronavirus infections.
vaccine candidate has shown good safety, tolerance, and immunogenicity in both preclinical studies and Phase 1 clinical trials.
interim data analysis of cove in phase 3 clinical trial COVE was based on an analysis of COVID-19 cases of symptoms that began to be confirmed two weeks after the second dose of the vaccine was given.
of the 95 cases accumulated, the placebo group observed 90 COVID-19 patients and the mRNA-1273 group observed 5 cases, calculating the effectiveness of the vaccine at 94.5% (p.lt;0.0001).
also analyzed data from patients with severe COVID-19.
Patients with severe COVID-19 not only showed COVID-19 symptoms, but also showed clinical manifestations of more severe systemic diseases, which may include respiratory failure or acute respiratory distress syndrome (ARDS), shock, severe kidney, liver and nervous system malfunsions, and needed emergency care or even death.
of the 11 severe COVID-19 patients included in the first interim analysis, all 11 were in the placebo group and no serious cases occurred in the mRNA-1273 vaccination group.
further analysis of the personal characteristics of the 95 COVID-19 patients found that 15 of them were over 65 years of age and 20 of the participants were from ethnic minorities.
DSMB also reviewed the safety data of existing Phase 3 clinical trials, DSMB did not report any significant safety issues.
review of adverse events has shown good vaccine tolerance.
most adverse events are mild or moderate in severity.
Level 3 events with a rate of more than 2% after the first dose included pain at the injection site (2.7%), and the main adverse events after the second dose included fatigue (9.7%), myalgia (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%).
these adverse events are usually short-lived.
analysis showed that the safety and efficacy characteristics of all the evaluation subgroups were basically the same.
stability data for mRNA-1273 Today, Moderna also announced the latest data for the stability study of mRNA-1273.
data show that mRNA-1273 remains stable for 30 days at the refrigerated temperature of a standard household or medical refrigerator (2 to 8 degrees C).
can remain stable for up to 6 months at a freezing temperature of -20 degrees C.
stability at room temperature for up to 12 hours.
means that the transport and long-term storage of mRNA-1273 will be available using the world's existing cold chain equipment.
thawed, it remains stable in most pharmacies, hospitals, and clinics.
resources: s1. Retrieved November 16, 2020, from [2] Moderna's COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study. Retrieved November 16, 2020, from [3] Draft landscape of COVID-19 candidate vaccines. Retrieved November 16, 2020, from。