European Commission authorizes COVID-19 vaccine Moderna in Europe

Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that 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. The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of 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.

"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," said Stéphane Bancel, Chief Executive Officer of Moderna. "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."

The European Union is the fourth jurisdiction to authorize Moderna's COVID-19 vaccine, following the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021. Additional authorizations are currently under review in Singapore, Switzerland and the United Kingdom.

On December 18, the EMA exercised its option to increase its confirmed order commitment by 80 million doses of Moderna's vaccine against COVID-19, bringing its confirmed order commitment to 160 million doses. The first deliveries of COVID-19 Vaccine Moderna to European countries from Moderna's dedicated non-U.S. supply chain are expected to begin next week.

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for COVID-19 Vaccine Moderna 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.

To learn more about Moderna's work on the Moderna COVID-19 Vaccine, visit www.modernatx.com/COVID19.

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 NIAID's 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 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.

Authorized Use

The COVID-19 Vaccine Moderna has been granted a Conditional Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency, 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.

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.

Most Popular Now

Sustained cellular immune dysregulation in individ…

COVID-19, which has killed 1.7 million people worldwide, does not follow a uniform path. Many infected patients remain asymptomatic or have mild symptoms. Others, espe...

New virtual screening strategy identifies existing…

A novel computational drug screening strategy combined with lab experiments suggest that pralatrexate, a chemotherapy medication originally developed to treat lymphoma, c...

Pfizer and BioNTech to supply the U.S. with 100 mi…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a second agreement with the U.S. government to supply an additional 100 million doses of the compan...

European Commission authorizes COVID-19 vaccine Mo…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the European Commission has granted a cond...

An in vitro study shows Pfizer-BioNTech COVID-19 v…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB...

Serum Institute of India obtains emergency use aut…

AstraZeneca's COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the act...

CureVac and Bayer join forces on COVID-19 vaccine …

Bayer has signed a collaboration and services agreement with CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines b...

New findings help explain how COVID-19 overpowers …

Seeking to understand why COVID-19 is able to suppress the body's immune response, new research from the USC Leonard Davis School of Gerontology suggests that mitochondri...

China grants conditional market approval for Sinop…

The inactivated COVID-19 vaccine developed by Beijing Institute of Biological Products of Sinopharm CNBG has been granted conditional registration by the NMPA of China, C...

Novavax announces initiation of PREVENT-19 pivotal…

Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVEN...

AstraZeneca's COVID-19 vaccine authorised for emer…

AstraZeneca's COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New...

Pfizer and BioNTech to supply the European Union w…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will supply an additional 100 million doses of COMIRNATY®, the companies' COVID-19 Vaccine, to the 2...