EC and UK authorise Moderna’s RNA-based COVID-19 Vaccine

The EC and UK have granted authorisation for the use of the Moderna COVID-19 Vaccine in individuals 18 years of age and older.

The European Commission granted a conditional marketing authorisation (CMA) for the Moderna COVID-19 Vaccine on the 6th January, allowing vaccination programs using the company’s mRNA vaccine to be rolled out across the European Union. The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has also announced, on the 8th January, the issuance of a temporary authorization which permits the supply of Moderna’s COVID-19 Vaccine in Great Britain.

The EC and UK authorisations follow those of the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021. Further authorisations are currently being reviewed in a number of other countries including Singapore and Switzerland.

The EC authorisation, based upon the recommendation of the European Medicines Agency (EMA), and the UK MHRA, based upon the recommendation of the Commission on Human Medicines, both authorise the use of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

Stéphane Bancel, Chief Executive Officer of Moderna, stated regarding the EC approval:

“I want to thank the European Commission for its engagement and endorsement and the EMA for its recommendation, which is another significant moment in our company’s history. The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization. I am proud of the role Moderna has been able to play globally in helping to address this pandemic.”

Regarding the UK approval Stéphane Bancel stated:

“We appreciate the confidence shown by the UK MHRA in COVID-19 Vaccine Moderna with this decision, which marks an important step forward in the global fight against COVID-19. I want to thank the MHRA and the Commission on Human Medicines’ reviewers for their tireless efforts. The authorization of a product developed by Moderna is a significant milestone on the Company’s 10-year journey, and I would like to thank all our colleagues that have helped us get to this point.”

The EMA exercised its option to increase its confirmed order commitment by 80 million doses of Moderna’s COVID-19 vaccine on December 18, bringing its confirmed order commitment to 160 million doses. The UK government’s total order of Moderna vaccines amounts to 17 million doses, following its exercise of the option to purchase an additional 10 million doses.

The first deliveries of the COVID-19 to EU countries and the UK from Moderna’s dedicated non-U.S. supply chain are expected to commence early in 2021.

About the Moderna’s RNA-based COVID-19 Vaccine

The Moderna COVID-19 Vaccine (also referred to as the COVID-19 Vaccine Moderna in the EU and UK) 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 NIAID’s Vaccine Research Center. The first clinical batch funded by the Coalition for Epidemic Preparedness Innovations was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, only 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 FDA 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. The Phase 2 study completed enrolment on the 8th of July 2020.

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 reputable medical journal, The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were also 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. Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases on November 30. On the same day, Moderna 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).

About Moderna

Moderna, a biotech company headquartered in Cambridge, Massachusetts, 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 with 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. 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, please visit www.modernatx.com.


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