Rising Number of Cases Reinforces the Need for Comprehensive Diagnostics
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Moderna, Inc. (NASDAQ: MRNA) announced yesterday that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).
Johnson & Johnson (NYSE: JNJ) announced recently the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen's investigational COVID-19 vaccine candidate. Under the amendment, Janssen will commit approximately USD 604 Million and BARDA will commit approximately USD 454 Million to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen's investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We greatly value the ongoing confidence and support of our investigational COVID-19 vaccine candidate development program. Combined with our own significant investment, this agreement has enabled our vital research and development and underscores the importance of public-private partnerships to tackle the worldwide COVID-19 pandemic."
BioNTech SE (NASDAQ: BNTX) together with Pfizer announced last week that they have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization. Vaccine doses for Europe will be produced in BioNTech's German manufacturing sites, as well as in Pfizer's manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then the European Commission will lead the process for allocation of the vaccine doses among the EU Member States who have elected to receive the vaccine as part of this agreement.
Dynavax Technologies Corporation (NASDAQ: DVAX) reported ack in August a grant from the Bill & Melinda Gates Foundation of USD 3.4 Million to scale up production batch size to allow for increased capacity of Dynavax's CpG 1018 advanced adjuvant to support the global COVID-19 response. These efforts will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed. "We are honored to receive this funding from the Bill & Melinda Gates Foundation to support development of a much-needed vaccine for COVID-19. This grant facilitates scale up of production capacity to ensure the availability of CpG 1018 for collaboration partners developing adjuvanted vaccines for COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We believe adjuvants will play an important role in developing effective vaccines for COVID-19, including for those patients at greatest risk for severe disease. The ability of CpG 1018 to potentially provide an improved immune response and also reduce the amount of vaccine antigen necessary will help provide more vaccine doses to meet the global need."
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