New contract to enable European countries access to updated COVID-19 vaccine booster candidates
Total of 460 million doses ordered by the European Commission
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine, including the ability to purchase other COVID-19 vaccine candidates from Moderna’s pipeline. This purchase brings the European Commission’s confirmed order commitment to 460 million 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 (EMA).
“We appreciate the collaboration with the European Commission for these additional doses of the Moderna COVID-19 vaccine, which could be used for primary vaccination, including of children, or possibly as a booster if that becomes necessary to continue to defeat the pandemic,” said Stephane Bancel, Moderna’s Chief Executive Officer. “We are encouraged by the initial booster data, which reinforce our confidence that our booster strategy should be protective against current variants. We will remain proactive as the virus evolves by leveraging the flexibility of our mRNA platform to stay ahead of emerging variants.”
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 U.S. 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 (CMA) for COVID-19 Vaccine Moderna, 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.
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. 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 U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency.
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. 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 (EUL) from the World Health Organization (WHO). 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 U.S., 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 (mRNA), 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. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine to protect against the SARS-CoV-2 virus (mRNA-1273, also referred to as COVID-19 Vaccine Moderna and the Moderna COVID-19 Vaccine); the Company’s agreement with the European Commission for the supply additional doses of the vaccine in 2022; the Company’s timely satisfaction of its delivery commitments for the vaccine; the anticipated number of doses capable of being produced from the Company’s production lines within the European Union; and the safety and efficacy of the vaccine at different doses and for variant-specific formulations of the vaccine. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
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