CAMBRIDGE, Mass .– (BUSINESS WIRE) – Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, today announced that it has entered into an agreement with Thermo Fisher Scientific (NYSE: TMO) for the manufacturing of sterile filling / finishing services and supply packaging for Moderna’s COVID-19 vaccine.
Under the terms of the agreement, Thermo Fisher’s commercial manufacturing site in Greenville, NC will be used for aseptic filling / finishing, labeling and packaging to support the production of hundreds of millions of Moderna COVID-19 vaccine doses. Production will begin in the third quarter of 2021.
“Thermo Fisher has been a critical partner in the supply of raw materials for our COVID-19 vaccine and we are now delighted to further extend our relationship as a significant manufacturing partner,” said Juan Andres, Director of Technical Operations and the quality of Moderna. “The addition of Thermo Fisher to our network will support our efforts to increase our manufacturing capacity. ”
In the 10 years since its inception, Moderna has grown from a company in the scientific research stage offering programs in the field of messenger RNA (mRNA) to a company with a diverse clinical portfolio of vaccines and therapeutic products through six modalities, a large intellectual property portfolio. in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speed. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has enabled the pursuit of groundbreaking science and the rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed 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 enabled the development of therapies and vaccines for diseases infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 24 development programs are underway in these therapeutic areas, of which 14 programs have entered the clinic. Moderna was named one of the top biopharmaceutical employers by Science for six years. To learn more, visit www.modernatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding Moderna’s development of a vaccine against SARS-CoV-2 (mRNA-1273) , and an agreement under which Thermo Fisher Scientific will provide sterile filling / finishing manufacturing services, as well as the labeling and packaging of the Moderna COVID-19 vaccine, as well as the timing and scale of these services. In some cases, forward-looking statements may be identified by words such as “will”, “may”, “should”, “could”, “expects”, “intends”, “intends”, “aims”, “ provides, “” Believe “,” estimate “,” predict “,” potential “,” continue “or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on such forward-looking statements as 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, among others: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the rapid response technology used by Moderna is still under development and implementation; the safety, tolerability and efficacy profile of Moderna COVID-19 vaccine observed to date may change unfavorably in ongoing analyzes of trial data or post-marketing; the Moderna COVID-19 vaccine may prove to be less effective against variants of the SARS-CoV-2 virus, or the Company may not succeed in developing future versions of its vaccine against these variants; despite ongoing interactions with the FDA or other regulatory agencies, the FDA or other regulatory agencies may not agree with the company’s regulatory approval strategies, components of our deposits, such as clinical trial designs, conduct and methodologies, or sufficiency of data submitted; Moderna may experience delays in meeting manufacturing or supply deadlines or disruptions in its distribution plans for the Moderna COVID-19 vaccine; whether and when biologic license applications and / or other emergency use authorization applications may be made in various jurisdictions and ultimately approved by regulatory authorities; potential negative impacts from the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain disruptions, adverse effects on health systems and disruption the world economy; and other risks and uncertainties described under “Risk Factors” in Moderna’s latest annual report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings by Moderna with the SEC, which are available on the SEC website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise 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.