15 March 2021 - - The first participants have been dosed in the Phase 1 study of mRNA-1283, US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) next generation COVID-19 vaccine candidate, the company said.

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 and N-terminal Domain.

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 two-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 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 US FDA and a Conditional Marketing Authorization 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 US 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.

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services is supporting the continued research and development of the company's COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034.

BARDA is reimbursing Moderna for 100 % of the allowable costs incurred by the company for conducting the program described in the BARDA contract. The US government has agreed to purchase supply of mRNA-1273 under US Department of Defense contract no. W911QY-20-C-0100.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

Moderna COVID-19 Vaccine is investigational and not approved by FDA.

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA, to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.

Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years.