12 February 2021 - - The Qatar Ministry of Public Health has issued an emergency use authorization for COVID-19 Vaccine Moderna, US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) said.

The approval is based on the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30.

Qatar has secured access to COVID-19 Vaccine Moderna through a supply agreement announced on October 26, 2020.

Moderna has also received authorization for its COVID-19 vaccine from health agencies in the United States, Canada, Israel, the European Union, the United Kingdom, Switzerland and Singapore.

Moderna said it is also working with additional health agencies and with the World Health Organization on the authorization of its vaccine in respective jurisdictions.

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 November 30, 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, 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 COVID-19 Vaccine Moderna has been granted emergency use authorization by the Qatar Ministry of Public Health.