Moderna announced that the first participants have been dosed in the Phase 1 study of mRNA-1283, the company’s next generation COVID-19 vaccine candidate.
“Our investments in our mRNA platform have enabled us to develop this next generation vaccine candidate, which is a potential refrigerator-stable vaccine that could facilitate easier distribution and administration in a wider range of settings, including potentially for developing countries. We remain committed to helping address this ongoing public health emergency.â€
This Phase 1 dose-ranging study will assess the safety and immunogenicity of mRNA-1283, a next-generation vaccine candidate against COVID-19.
mRNA-1283 encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD).
The encoded mRNA-1283 antigen is being developed as a potentially refrigerator-stable mRNA vaccine that will facilitate distribution and administration by healthcare providers.
This Phase 1 study will evaluate three dose levels, 10 µg, 30 µg, and 100 µg, of the mRNA-1283 vaccine candidate given to healthy adults as a 2-dose series, 28 days apart, and one dose level, 100 µg, of mRNA-1283 given to healthy adults in a single dose.
These will be compared with a 2-dose series of 100 µg of mRNA-1273, the currently authorized dose level. mRNA-1283 is intended to be evaluated in futures studies for use as a booster dose for previously vaccinated or seropositive as well as in a primary series for seronegative individuals.
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center.
The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 2020, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing.
On May 12, 2020, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrolment.
Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29, 2020 in The New England Journal of Medicine.
On July 28, 2020, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, 2020, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.
On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency.
On December 3, 2020, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination).
On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.
Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization. ■