Singapore Health Sciences Authority (HSA) Approves Interim Authorization of COVID-19 Vaccine Moderna For Use


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MRNA-1273 (SARS-CoV-2 vaccine)

 

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 3, 2021 -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Singapore Health Sciences Authority (HSA) has approved the interim authorization of its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under the Pandemic Special Access Route (PSAR).

“Today’s authorization is another important step in the global fight against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I want to thank the Singapore Ministry of Health and the HSA for their collaboration and for the confidence they have demonstrated in COVID-19 Vaccine Moderna with this decision.”

The Singapore Ministry of Health has secured access to COVID-19 Vaccine Moderna through a supply agreement announced on December 14, 2020. The authorization 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, 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 and Switzerland. Additional authorizations are currently under review in other countries and by the World Health Organization.

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. 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 NIH National Institutes of Health (NIH) 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 U.S. FDA and a Conditional Marketing Authorization (CMA) 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 U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. On December 23, 2020, Health Canada authorized Moderna’s vaccine against COVID-19 for the immunization of people 18 years of age and older under an Interim Order. On January 4, 2021, Israel’s Ministry of Health (MOH) authorized the importation of the COVID-19 Vaccine Moderna in Israel. On January 6, the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

Authorized Use

The COVID-19 Vaccine Moderna has been granted an interim authorization by the Health Sciences Authority (HSA) in Singapore under the Pandemic Special Access Route (PSAR) .

About Moderna

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Source: Moderna, Inc.

Posted: February 2021

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