IowaBio wants to provide our members useful information during the COVID-19 pandemic. This newsletter compiles information on state, federal and industry action to combat the virus and its impacts.
If your company is helping respond to COVID-19, IowaBio wants to know about it. Please, send any information about what your biotechnology company or organization is doing to help, to Jessica Hyland at Jessica@iowabio.org.
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Past IowaBio COVID-19 Update newsletters are now available at www.iowabio.org/COVID19 and can be found under the Industry News tab on the IowaBio website.
Moderna announced this morning that a clinical trial involving more than 30,000 patients shows its vaccine is safe and almost 95 percent effective to prevent COVID-19.
“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 Stéphane Bancel, Chief Executive Officer of Moderna. “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 in the U.S., and regulatory filings in countries around the world, while 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 Emergency Use Authorization (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 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies.
Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. 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, the Company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. 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 (code: 91301). Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.
Currently, IDPH has reported on the state’s coronavirus dashboard, 187,001 Iowans have tested positive, up 11,576 from our update Friday morning, with a total of 1,105,462 tested. 42 additional deaths were reported since our last update, bringing the total to 1,989 deaths. Now 108,175 Iowans have recovered. The overall positivity rate is 16.9% and the total 14 day rolling average positivity rate is 23.2%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here. There are currently 1,392 hospitalized patients.
School district statistics including positivity rates by county can be found here. According to guidance issued by the Iowa Department of Education, schools may petition to go to hybrid or online learning with less than 50 percent in-person instruction when the per county percentage positivity rates are above 15 percent in a county on average over the past 14 days (rolling average) AND 10% absenteeism among students is expected for in-person learning. School district waiver requests and whether they are granted or denied are listed here.
Currently 94 (of 99) counties are above a 15 percent positivity rate over the past 14 days. Because there are a high number of counties to report, this newsletter will no longer list them individually. Click here to search county data for today.
Total Cases 10,846,373
Total Deaths 244,810
Total Cases 54,495,858
Total Deaths 1,318,884