Page 8 THE EVERETT ADVOCATE – FRIDAY, NOVEMBER 20, 2020 Moderna announces COVID-19 vaccine candidate with 94 percent efficacy C AMBRIDGE – Biotechnology company Moderna, Inc. recently announced the Phase 3 study of mRNA-1273, a vaccine candidate against COVID-19. The Coronavirus Efficacy and Safety Study (COVE) has enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). 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 five cases observed in the mRNA-1273 group, resulting in an efficacy rate of 94.5 percent. A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA1273 vaccinated group. The 95 COVID-19 cases included 15 adults over the age of 65 and 20 participants from diverse communities. The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the Data Safety Monitoring Board (DSMB), which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated; most adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to two percent in frequency after the first dose included injection site pain (2.7 percent), and after the second dose included fatigue (9.7 percent), myalgia (8.9 percent), arthralgia (5.2 percent), headache (4.5 percent), pain (4.1 percent) and erythema/redness at the injection site (two percent). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis. Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups. As more cases accrue leading up to the final analysis, Moderna expects the point estimate for vaccine efficacy might change. The company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication. “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Moderna CEO Stéphane Bancel. “This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. We look forward to the next milestones of submitting for an EUA [Emergency Use Authorization] in the U.S. and regulatory filings in countries around the world, KIWANIS | FROM PAGE 3 her memory alive by doing what she always loved to do and that’s helping people in need. Especially with the holiday season nearing, we hope this will help lots of people in need. Of course, this would not be possible without the continuous show of love and support from family, friends and the community.” Kiwanis President James Mitchell said the club raised $20,000 during the second annual 5K Walk for Ersilia, which was held on October 3. “Kids need Kiwanis, now more than ever before, and Bread of Life and Grace Food Pantry are great examples of how our club can meet the needs in our community,” he said. “These two worthy institutions feed the needy famwhile we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.” Based on these interim safety and efficacy data, Moderna intends to submit for an EUA with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least two months). Moderna also plans to submit applications for authorizations to global regulatory agencies. Moderna is working with the Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson – a COVID-19 vaccine distributor contracted by the federal government – as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations. By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA1273 ready to ship in the United States. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273. Moderna recently announced that further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure. ilies of Everett throughout the year, and it’s an honor to help those who help feed Everett’s families.” The Kiwanis Club of Everett operates various annual local projects to benefit children, including Thanksgiving turkey dinners donated by member Carl Penta of McKinnon’s Supermarket in Everett and Christmas Angel Tree gift cards as well as hats and mittens for students. “Annually the Kiwanis Club of Everett hosts a number of fundraisers, including the Kiwanis Pasta Supper, the Frank E. Woodward golf tournament and the 5K Walk for Ersilia, all to raise money to provide scholarships for Everett students. Everett Kiwanis provides 12 scholarships annually ranging from $1,000 to $2,000,” said Mitchell.
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