Therapy Areas: Inflammatory Diseases
European Commission Authorizes COVID-19 Vaccine Moderna in Europe
6 January 2021 - - The European Commission has granted a conditional marketing authorization for COVID-19 Vaccine US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA), allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union, the company said.

The authorization is based upon the recommendation of the European Medicines Agency 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.

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 80m doses of Moderna's vaccine against COVID-19, bringing its confirmed order commitment to 160m doses.

The first deliveries of COVID-19 Vaccine Moderna to European countries from Moderna's dedicated non-US supply chain are expected to begin next week.

The EMA's Committee for Medicinal Products for Human Use 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.

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 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 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.

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 authorized the importation of the COVID-19 Vaccine Moderna in Israel.

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.

Moderna is advancing messenger RNA 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 and Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years.
Login
Username:

Password: