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Resilience to Manufacture mRNA for Moderna’s COVID-19 Vaccine
In other COVID news, Novavax launches a clinical trial of its combination COVID-19/ flu vaccines and Takeda will manufacture 150M doses of Novavax’s COVID-19 vaccine in Japan.
National Resilience recently entered into a multi-year agreement with Moderna to manufacture drug substance mRNA for its COVID-19 vaccine.
Resilience is a manufacturing and technology company founded in 2020 to boost access to complex medicines and protect biopharmaceutical supply chains against distribution.
Under the terms of the agreement, Resilience will produce mRNA for the Moderna COVID-19 vaccine at its facility in Canada. The company will distribute the vaccine globally.
“Moderna’s COVID-19 vaccine has saved countless lives, and we’re excited to manufacture mRNA for this important vaccine,” Rahul Singhvi, ScD, chief executive officer of Resilience, said in the announcement.
“This collaboration has the potential to ensure more people are protected around the world from the deadly COVID-19 virus,” Singhvi continued.
Moderna also announced a collaboration to bring mRNA manufacturing to Canada through a Memorandum of Understanding (MoU) with the Canadian government. The collaboration will build an RNA vaccine manufacturing facility in the country, including access to Moderna’s mRNA development engine.
The MoU will provide the foundation to support Canada with direct access to rapid pandemic response capabilities and access to Moderna’s vaccines in development for respiratory viruses.
Novavax Launches Phase 1/2 Trial of Combination COVID-19, Flu Vaccine
Novavax recently announced that it enrolled the first participants in a Phase 1/2 study evaluating its seasonal flu and COVID-19 vaccines as a combination vaccine.
The clinical trial combines the company’s recombinant protein-based NVX-CoV2373 vaccine and the NanoFlu vaccine. Both the vaccines previously elicited strong results as standalone vaccines in Phase 3 clinical trials.
For example, the COVID-NanoFlu Combination Vaccine demonstrated robust immune responses to each component of the quadrivalent influenza vaccine and SARS-CoV-2 spike protein.
And NVX-CoV2373 elicited 100 percent protection against moderate to severe COVID-19 infection and 90.4 percent efficacy overall in a Phase 3 trial.
The Phase 1/2 study will evaluate the safety, tolerability, and immune response to NanoFlu formulated together with NVX-CoV2373 and Matrix-M adjuvant in 640 healthy adults 50 to 70 years of age.
Participants in the study were either already infected with COVID-19 or received the coronavirus vaccine at least eight weeks before enrollment. Novavax expects trial results in the first half of 2022.
“This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously,” Gregory M. Glenn, MD, president of research and development at Novavax, said in the announcement.
“The combination of these two vaccines may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen,” Glenn concluded.
Takeda to Manufacture 150M Doses of Novavax’s COVID-19 Vaccine in Japan
Takeda recently announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHL) will purchase 150 million doses of Novavax’s COVID-19 vaccine candidate.
Takeda will manufacture doses of the vaccine, NVX-CoV2373, in Japan and expects to begin distribution in early 2022. The companies did not release the details of the terms and conditions of the agreement.
Novavax is licensing and transferring manufacturing technologies to allow Takeda to manufacture the vaccine antigen. The company is also supplying the Matrix-M adjuvant to Takeda for fill/finish together with the antigen.
“This agreement demonstrates confidence in an ongoing global demand for NVX-CoV2373 as a significant additional option to control the COVID-19 pandemic,” Stanley C. Erck, president and chief executive officer at Novavax, said in an official statement.
“Our important partnership with Takeda is an example of the global collaborations that will be required to stay ahead of the virus and its variants,”” Erck continued.
