Therapy Areas: Vaccines
European Commission Purchases Additional 150m Doses of Moderna's COVID-19 Vaccine for Delivery in 2022
22 June 2021 - - The European Commission has purchased an additional 150m doses of US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) COVID-19 vaccine, including the ability to purchase other COVID-19 vaccine candidates from Moderna's pipeline, the company said.

This purchase brings the European Commission's confirmed order commitment to 460m doses.

Under the terms of the agreement, delivery of Moderna's updated variant booster vaccine candidate will begin in 2022.

Purchase under this agreement is subject to regulatory approval of the booster vaccine candidates by the European Medicines Agency.

Moderna remains on track to meet its quarterly delivery commitments to the European Union in 2021, as the company continues to build out its supply chain in Europe.

Initial data from Moderna's Phase 2 study in the US showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil).

A booster dose of mRNA-1273.351, the company's strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273.

Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies.

A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm.

The European Commission granted a conditional marketing authorization for COVID-19 Vaccine Moderna, 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 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. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.

On November 30, 2020, 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 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 emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and an Emergency Use Listing from the World Health Organization.

Moderna has filed for emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adolescents with health agencies in the European Union, Canada, the US, Switzerland and Japan.

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA, to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.

Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Today, 24 development programs are underway across these therapeutic areas, with 14 programs having entered the clinic.
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