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COVID-19 Update
September 17, 2020
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.

If IowaBio can assist you in getting information out, connecting with public officials, or support your company in another way, please do not hesitate to reach out.

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.

Iowa Update

Currently, IDPH has reported on the state’s coronavirus dashboard, 76,863 Iowans have tested positive, up 1,141 from our update yesterday morning, with a total of 718,845 tested. Antigen test results are now included in the overall data and broken out separately from PCR test results in the data here. 14 additional deaths were reported since our last update, bringing the total to1,248 deaths. Now 55,727 Iowans have recovered. The overall positivity rate is 10.7% and the total 14 day rolling average positivity rate is 8.3%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.
 
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.
 
Currently 6 counties are above 15 percent positivity rate over the past 14 days:
Sioux 27.9%
Lyon 23.5%
Winnebago 16.8%
Carroll 16.6%
Crawford 16.3%
Plymouth 16.3%
 
The Office of Governor Kim Reynolds released the agenda for the next Governor’s Economic Recovery Advisory Board meeting for Thursday September 17 at 9:00 a.m..The agenda can be found here. The Advisory Board focuses on COVID-19 economic recovery. Members of the public interested in participating should contact Ryan Capps, ryan.capps@governor.iowa.gov
 
Federal Actions
  • HHS and DoD released documents outlining the Administration’s plan for distributing and administering millions of doses of a future COVID-19 vaccine to Americans for free. The plan involves an information campaign led by the HHS public affairs department; ramping up infrastructure so a vaccine can be delivered quickly once authorized; and sending 6.6 million kits of supplies needed to administer the vaccine, like syringes and alcohol pads. The strategy is outlined in a report to Congress and a 57-page playbook to states.
  • The NIH has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals. The list of awardees can be found here
  • The NIH also announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center. 
  • The FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA).
  • The FDA awarded a new research contract to the University of Liverpool and global partners to sequence and analyze samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19. The study will also examine in vitro coronavirus models, such as organs-on-chips. This regulatory science project, awarded in collaboration with the NIH/NIAID, will hopefully help inform development and evaluation of medical countermeasures for COVID-19.
  • The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
    • September 23, 12:15 PM
    • September 30, 12:15 PM
  • As of yesterday, 249 tests are authorized by FDA under EUAs; these include 198 molecular tests, 47 antibody tests, and 4 antigen tests.
  • The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9 percent sodium chloride injection, indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth. This drug is included in the FDA’s Drug Shortage Database.
  • Yesterday, the CDC released indicators to help schools make dynamic decisions about in-person learning as local conditions evolve throughout the pandemic. When coupled with local data about community spread, these indicators are an important tool to help local health officials, school administrators, and communities prepare, plan, and respond to COVID-19. These indicators are the latest resources CDC has provided for schools during the COVID-19 pandemic, and they supplement previously released CDC guidance.
  • CMS received the final report from the independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission), which was facilitated by MITRE.  CMS also released an overview of the actions the agency has taken to date to combat the spread of COVID-19 in nursing homes. The Commission’s findings align with the actions CMS has taken to contain the spread of the virus and to safeguard nursing home residents from the ongoing threat of COVID-19. 
  • Sens. Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) wrote a letter to HHS Sec. Alex Azar and Education Sec. Betsy DeVos encouraging the Education Department to issue new guidance for how schools and colleges should address the unique and increased mental health challenges students are facing due to COVID-19. In the letter, the Senators requested information about how schools and colleges should use federal funds to support students’ mental health needs, with a particular focus on minorities or those from tribal nations, students with disabilities, and students experiencing homelessness.
  • Rep. Jim Clyburn (D-SC), Chairman of the Select Subcommittee on the Coronavirus Crisis, sent a letter to Vice President Pence and Coronavirus Response Coordinator Dr. Deborah Birx raising concerns that the Task Force has weakened or retracted previous science-based recommendations in numerous states still in the “red zone,” including states that failed to comply with previous Task Force recommendations. The letter also demands the release of all White House Coronavirus Task Force reports tracking the spread of the virus and making recommendations to contain the outbreak. 
  • The Senate Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies met yesterday for a hearing at 10 AM titled, "Department of Health and Human Services’ Coronavirus Response: A Review of Efforts To Date and Next Steps." During the hearing, CDC Director Robert Redfield said he thought a vaccine would not be publicly available until the middle or end of 2021. President Trump later contradicted that, saying he thought perhaps Dr. Redfield had made a mistake. 
  • Assistant sec. of public affairs for HHS, Michael Caputo, announced he will be taking a two month leave of absence, after he said he and his team had tried to water down MMWR reports out of the CDC. Caputo's science advisor, Dr. Paul Alexander, is leaving HHS entirely.
  • An unidentified White House staff member has tested positive for COVID-19. 
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 6,571,867 total cases and 195,053 deaths The CDC data closes out the day before reporting. 
  • Wyoming announced more than 120 new cases, far and away state’s highest daily total during the pandemic.
  • New Jersey and New York's regional travel advisory was updated. Puerto Rico was added to the list, and California, Hawaii, Maryland, Minnesota, Nevada, and Ohio were removed.
  • New York state's COVID-19 positivity rate rose above 1 percent this week for the first time in more than a month.
  • Colorado Gov. Jared Polis (D) announced that the state would be implementing a new framework that allows counties to reopen their economies to the fullest extent possible while protecting their communities. This tool will provide transparency and predictability for local governments and allow for a visual representation of a county’s success in suppressing the virus. 
  • Connecticut Gov. Ned Lamont signed an executive order that authorizes the commissioner of Public Health, local health departments, municipal chief elected officers, and state and local police to issue fines for violations of certain COVID-19 protective measures. Violations include failing to wear a mask or cloth face covering as required, organizing, hosting, or sponsoring a gathering that violates the gathering size restrictions, and attending a gathering that violates the gathering size restrictions.
  • Gov. Lamont also signed an EO that modifies the state’s previously issued self-quarantine and travel advisory order for people arriving to Connecticut from impacted states, expanding the testing exemption to all travelers who test negative for COVID-19 in the 72 hours prior to arrival. 
  • Delaware Gov. John Carney (D) launched COVID Alert DE – a mobile app that will help Delaware fight community spread of COVID-19. The free mobile app – available to anyone 18 or older who lives, works, or attends college in Delaware – uses Bluetooth technology from Google and Apple to securely and anonymously alert users who have been in close contact with someone who tested positive for COVID-19.
  • Nevada Gov. Steve Sisolak (D) signed an emergency regulation to support widespread immunization efforts to help the State prepare for a potential COVID-19 vaccine. The regulation, approved and requested by the Nevada State Board of Pharmacy, authorizes pharmaceutical technicians with appropriate training to administer immunizations under the direct supervision of a pharmacist.
  • Mayor Carlos Gimenez of Miami-Dade County, Florida, said he would allow the staggered opening of additional indoor spaces. Starting Friday, movie theaters, bowling alleys, banquet halls, and a few other venues will be allowed to open at half-capacity as long as they require masks and social distancing and meet certain ventilation requirements.
  • A wedding in Maine in early August only had 65 guests but has been linked to seven deaths 175 cases of COVID-19. Six of the people who have died had no connection to the wedding. 
  • Useful state data:
    • Use Johns Hopkins University’s COVID-19 U.S. map as a resource for media, policymakers, and communities to view a collection of critical public health data in one online destination and better understand and track the COVID-19 pandemic in populations both large and small across the country.
    • NASHP has developed a COVID-19 State Action Center which serves as a state-level policy dashboard. Governing is also keeping a running tally of coronavirus news and impacts at the intersection of the health and economic crises in the states and localities.
    • This site from the Kaiser Family Foundation provides state-level information on cases/deaths, social distancing measures, health policy actions, and more.
    • This series of maps shows how states are responding to COVID-19, and this tracker, created and maintained by MultiState Associates, has an up-to-date list of executive orders and various travel restrictions.
International Affairs
  • U.N. secretary general, António Guterres, said yesterday that COVID-19 is the world's top security threat. He went on to call for greater cooperation to develop and distribute an affordable vaccine, and criticized misinformation campaigns that could dissuade people from getting vaccinated.
  • Indian company Dr. Reddy’s Laboratories is the newest customer of Russia’s vaccine, which has been approved by the government but not yet fully been tested for safety and efficacy. Dr. Reddy’s agreed first to cooperate on clinical trials and, if they are successful, to buy 100 million doses.
  • Israeli reporters who had covered a large White House event were sent into quarantine upon returning home. 
  • India recorded its five millionth case yesterday, less than a month after hitting the three million mark. 
  • As cases in Madrid continue to increase, a health official from Madrid’s regional government warned that the capital was preparing to impose “selective lockdowns” in certain districts.
  • After six months, and in an effort to bring back tourists to boost the economy, Nepal is starting to allow mountaineers and trekkers back to the country.
  • The mayor of Paris announced that the city’s temporary expansion of bike lanes to facilitate travel during the pandemic would become permanent.
  • Global Cases: 29,897,412     Total Deaths: 941,363
Lifestyle, Science, and Economy
  • As was reported in a MMWR article yesterday, among 121 COVID-19-associated deaths among individuals younger than 21 years, 10 percent were infants and 70 percent were aged 10–20 years. Hispanic, non-Hispanic Black, and non-Hispanic American Indian/Alaskan Native individuals accounted for 78 percent of these deaths.
  • New York Gov. Andrew Cuomo (D) launched the latest "Mask Up, America" campaign video featuring Paul Rudd. The video is aimed at younger Americans to inform them of the importance of wearing masks during the COVID-19 pandemic to protect themselves and others.
  • Federal Reserve officials said yesterday that they plan to keep interest rates near zero through at least 2023. Officials are also predicting that unemployment will fall to 7.6 percent by the end of this year and to 5.5 percent by the end of 2021.
  • Since the start of the pandemic, the U.S. has seen a 13,200 jump in excess deaths from Alzheimer’s and dementia. Doctors have reported increased falls, pulmonary infections, and frailty in patients who were previously stable for years. According to one doctor, some patients can no longer swallow food and others are so depressed they cannot get out of bed.
  • Drug company Eli Lilly says a single infusion of its experimental drug has markedly reduced blood levels of the coronavirus in newly infected patients and lowered the chances that they would need hospitalization. The drug is a monoclonal antibody, a manufactured copy of an antibody produced by a patient who recovered from COVID-19. Many scientists hope that monoclonal antibodies will prove to be powerful treatments for COVID-19, but they are difficult and expensive to manufacture, and progress has been slow.
  • Gauss, a computer vision startup, and Cellex, a biotech company that works on diagnostics, announced the first rapid COVID-19 test that can be fully performed by people at home without involving a laboratory. The test has not been issued an EUA by the FDA. 
  • According to a recent Kaiser Family Foundation poll, 6 in 10 adults are worried the FDA will rush to approve a vaccine due to political pressure.
  • The Big Ten Conference said it would try to play football as soon as the weekend of October 23. The league said players, coaches, trainers and others on the field would undergo daily testing for the virus, and that any player who tested positive would be barred from games for at least 21 days.
  • At the University of Wisconsin-Madison, which is also part of the Big Ten and saw a sharp uptick in cases last week, local health authorities ordered all Greek organizations with one or more cases among their live-in members to quarantine. Some states, like Kansas, Colorado, and Michigan, have tracked COVID-19 clusters back to Greek houses.
  • Yelp released data showing 60 percent of business closures due to COVID-19 lockdowns are now permanent.
  • Major League Baseball and its players’ union reached agreement Tuesday on the format for the expanded, 16-team postseason, which will see the final three rounds played in controlled, neutral-site bubbles in Southern California and Texas and the World Series at the Texas Rangers’ new stadium in Arlington.
  • The WHO keeps a running list of COVID-19 vaccine candidates, which you can view here. STAT News also has a resource tracking COVID-19 drugs and vaccines. The New York Times has a very helpful vaccine tracker as well, which you can view here
  • BIO’s COVID-19 pipeline tracker for vaccines, treatments and antivirals is here.
  • The Johns Hopkins Center for Health Security has an extensive list of commercial and lab-developed tests. 
  • The NIH Office of Portfolio Analysis’s (OPA) expert-curated portfolio of COVID-19 publications and preprints. The portfolio includes peer-reviewed articles from PubMed and preprints from medRxiv, bioRxiv, ChemRxiv, and arXiv. is updated daily with the latest available data and enables users to explore and analyze the rapidly growing set of advances in COVID-19 research.
Helpful Articles/Media
Sincerely,
Jessica

Jessica Hyland, J.D.
Executive Director
Iowa Biotechnology Association
Cell: (515) 822-1315
Office: (515) 327-9156
Fax: (515) 327-1407
jessica@iowabio.org
www.iowabio.org
Copyright © 2020 Iowa Biotech Association, All rights reserved.


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