3 February 2021 - - The Swiss Federal government has increased its confirmed order commitment from 7.5m to 13.5m doses of the COVID-19 Vaccine Moderna in Switzerland, US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) said.

The initial procurement by the Swiss Federal government for 4.5 m doses was announced on August 7, 2020, and this was subsequently increased to 7.5 m doses on December 8, 2020.

The additional 6m doses announced TODAY will be delivered beginning in the summer of 2021, with an option to receive doses in the first half of 2022 as Moderna explores potential vaccine boosters to address emerging variants.

On January 12, 2021, Swissmedic authorized the COVID-19 Vaccine Moderna, according to the ordinary approvals procedure and based on a rolling submission of data and the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020.

The COVID-19 Vaccine Moderna (referred to in the US as 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, 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, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

On May 29, 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, 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 in The New England Journal of Medicine.

On July 28, 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, 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, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.

On December 3, 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).

The COVID-19 Vaccine Moderna has been granted approval by Swissmedic, the Swiss Agency for Therapeutic Products, based upon the recommendation of the Human Medicines Expert Committee, which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

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.

Currently, 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.