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COVID-19 Update
September 15, 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, 75,069 Iowans have tested positive, up 393 from our update yesterday morning, with a total of 706,023 tested. Antigen test results are now included in the overall data and broken out separately from PCR test results in the data here. 3 additional deaths were reported since our last update, bringing the total to 1223 deaths. Now 54,237 Iowans have recovered. The overall positivity rate is 10.6% and the total 14 day rolling average positivity rate is 8.6%. 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 4 counties are above 15 percent positivity rate over the past 14 days:
Sioux 23.9%
Lyon 16.0%
Bremmer 15.7%
Plymouth 15.6%

Federal Legislation
Supplemental IV
Timeline/Process/Politics: Negotiations remain stalled. Last week Senate Republicans released and voted on a revised version of their skinny bill. While it failed to pass the Senate, it received almost unanimous support from Republicans. While Democrats bashed the bill, a Democratic caucus call on Thursday revealed that more rank and file Democrats have been feeling pressure from constituents to make a deal on another coronavirus relief bill. While Democrats are unified in that they do not support passing the “extra skinny” proposal Senate Republicans released last week, they may begin pushing harder for a deal in the coming weeks. Speaker Pelosi has suggested that Democrats will not move until the major priorities outlined in the Heroes Act (state/local/tribal funding, unemployment insurance, postal funding, election funding, individual stimulus, testing etc.) receive funding, and until then there is not a compromise to be made. 
 
Many are skeptical anything COVID-related can get done over the next couple weeks before a continuing resolution (CR) needs to be passed. As negotiations remain stalled, it is becoming increasingly likely that a CR will be passed separate from any COVID package. House leaders have indicated that they want to put a CR on the House floor during the week of September 21.
 
Policy: Last week Senate Republicans released and voted on another COVID proposal. While it did not pass the Senate, it can be seen as a marker for the priorities Republicans will focus on in negotiations. Text here. Summary here. The bill clocks in at $300 billion, after offsets. There were many similarities between the bill and the one Republicans released mid-August.  See below for the highlights.
  • Offsets from $204 billion from funding allocated to Federal Reserve programs in CARES, sets the 13(3) facilities to expire in January, rescinds $146 billion in unspent small business funding from CARES Act.
  • Liability protections for businesses and healthcare providers;
  • $300 per week in enhanced unemployment insurance through the end of the year;
  • Small Business policies including:
    • Allows small businesses to take out a second Paycheck Protection Program (PPP) loan if they have revenue loss of 35 percent or more (HEALS set the threshold at 50 percent or more);
    • Provides $257.7 billion for PPP, which includes $100 billion in unused funds;
    • Simplification of the loan process (Sen. Cramer’s Paycheck Protection Small Business Forgiveness Act);
    • Additional reporting required for businesses receiving loan forgiveness;
    • Funding for audits.
  • $10 billion for the U.S. Postal Service – the bill would convert a $10 billion loan to the USPS into a grant if the USPS falls below $8 billion in cash on hand.
  • Education policies including:
    • Funding for scholarship-granting organizations for expenses like private school tuition and home-schooling expenses; Also, provides tax credits for two years dedicated for scholarship granting organizations (School Choice Now Act);
    • Allow students to use 529 plan funds for relevant expenses for two years (Student Empowerment Act);
    • Childcare program included in HEALS (see here for HEALS education text)
  • Health policies and funding, including:
    • Pandemic preparedness program (supply chain, SNS) in HEALS (see here for HEALS education text)
  • Extends when states/local/tribal governments must spend CARES Act funding until September 30, 2021 (extended from December 31, 2020).
  • Increases tax incentives for charity from $300 above-the-line deduction (as implemented in the CARES Act) to $600 for individuals and $1,200 for those filing a joint return.
  • Appropriations title, including:
    • $105 billion for Education Stabilization Fund (66 percent for K-12 and 29 percent for higher education and 5 percent to governors to use for either higher education or K-12);
    • $16 billion for testing/contact tracing;
    • $31 billion for vaccine and treatment development and distribution (the mid-August skinny bill allocated $29 billion for these purposes);
    • $20 billion for farm assistance,
    • $500 million for fisheries, and
    • $15 billion for child care ($5 billion for Child Care Development Block Grant and $10 billion for the program authorized above “Back to Work Child Care Grants”).
HEALS: Senate Republicans released the eight-bill package the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act on July 27. See the following for the individual bills. American Workers, Families, and Employers Assistance Act (Senate Finance Committee provisions) text here, section by section hereContinuing Small Business Recovery and Paycheck Protection Program Act (Small Business provisions) press release here, text here, section by section here, one pager hereCoronavirus Response Additional Supplemental Appropriations Act (Appropriations provisions) text here, summary hereRestoring Critical Supply Chains and Intellectual Property Act (Supply Chain and Research provisions) text here, section by section hereSAFE TO WORK Act (Liability Relief) text here, section by section hereSafely Back to School and Back to Work Act (Health, Education, and Labor Provisions) text here, section by section hereSupporting America’s Restaurant Workers Act text here. TRUST Act text here, section by section here, one pager here.

HEROES: The House passed the Democrats’ opening bid for the next bill, the Heroes Act, on May 15. While it’s been over two months since House passage of the bill and the contours of the debate and which issues are most pressing have shifted slightly, it can still serve as a marker of what Senate Republicans will be responding to in their bill. Heroes Act text (as of 5/12/2020) here. Section by section here. One pager here. State and Local one pager here. NCAI’s summary on tribal provisions here. Manager’s amendment here. House Rules Committee report here.
 
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (0): 
Currently Self-Quarantined (0): 
Recovered (15): Sen. Rand Paul (R-KY), Rep. Joe Cunningham (D-SC), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL), Rep. Mike Kelly (R-PA), Rep. Nydia Velazquez (D-NY), Rep. Neal Dunn (R-FL), Rep. Tom Rice (R-SC), Rep. Morgan Griffith (R-VA), Rep. Louie Gohmert (R-TX), Rep. Raúl Grijalva (D-AZ), Rep. Rodney Davis (R-IL), Sen. Bill Cassidy (R-LA), Rep. Jenniffer Gonzalez-Colon (R-Puerto Rico at large), Rep. Dan Meuser (R-PA)
Completed Quarantine (45): Sen. Ted Cruz (R-TX), Rep. Mark Meadows (R-NC)*, Sen. Lindsay Graham (R-SC), Rep. Don Beyer (D-VA), Rep. Sharice Davids (D-KS), Rep. Doug Collins (R-GA), Rep. Paul Gosar (R-AZ), Sen. Cory Gardner (R-CO), Sen. Rick Scott (R-FL), Rep. Matt Gaetz (R-FL), Rep. Jason Crow (D-CO), Rep. Julia Brownley (D-CA), Rep. Ben Ray Luján (D-NM), Rep. Gwen Moore (D-WI), Rep. Stephanie Murphy (D-FL), Rep. John Yarmuth (D-KY), Rep. Adam Schiff (D-CA), Rep. Vincente Gonzalez (D-TX), Rep. Drew Ferguson (R-GA), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Ann Wagner (R-MO), Rep. Kathleen Rice (D-NY), Rep. Matt Cartwright (D-PA), Rep. Tom Cole (R-OK), Rep. Steve Scalise (R-LA), Rep. Frederica Wilson (D-FL), Rep. Andy Kim (D-NJ), Rep. Kendra Horn (D-OK), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT), Rep. Katie Porter (D-CA), Rep. Seth Moulton (D-MA), Rep. Lizzie Fletcher (D-TX), Rep. Josh Gottheimer (D-NJ), Rep. Ayanna Pressley (D-MA), Rep. Mikie Sherrill (D-NJ), Sen. Lamar Alexander (R-TN), Rep. Randy Weber (R-TX), Rep. Kay Granger (R-TX), Rep. Mike Johnson (R-LA), Rep. Jody Hice (R-GA), Rep. Guy Reschenthaler (R-PA)
 
*Mark Meadows quarantined March 9 – 12 after coming in contact with a CPAC attendee who tested positive. On March 20, he resigned from his position in the House to become the White House Chief of Staff.

Other Federal Actions
  • Late Monday, President Trump signed an Executive Order tying the prices paid by the U.S. government for medicines procured under Medicare Part B and D to the lowest price paid by any OECD member country at a level of development and per capita GDP comparable to that of the United States. Many fear this will negatively impact the very companies developing drugs to fight COVID-19. Some reaction below:

    BIO’s Dr. McMurry-Heath Says Adopting Foreign Price Controls a “Reckless Scheme” that will “Eliminate Hope for Vulnerable Seniors” - “With scientists and researchers at America’s biopharmaceutical companies working around the clock to fight a deadly pandemic, it is simply dumbfounding that the Trump administration would move forward with its threat to import foreign price controls and the inevitable delays to innovation that will follow.” – Dr. Michelle McMurry-Heath, President and CEO, BIO

    PhRMA Statement on Most Favored Nation Executive Order – “PhRMA is committed to working with all stakeholders, including elected officials across the ideological spectrum, to find market-based, competitive reforms to the challenges facing our health care system and patients. The focus of any reforms must be on lowering costs for patients, ensuring patients’ access to medicines, addressing the misaligned incentives in the pharmaceutical supply chain and protecting the critical work being done to end COVID-19. Unfortunately, instead of pursuing these reforms the White House has doubled down on a reckless attack on the very companies working around the clock to beat COVID-19.”

    U.S. Chamber Calls Executive Orders on Drug Pricing ‘Flawed and Dangerous Policy’ Coming at ‘the Worst Possible Time’ - “The extent of U.S. leadership in bio-pharmaceutical research and development has never been more evident or important than in the COVID-19 pandemic. Importing price controls from foreign countries is flawed and dangerous policy that will result in a substantial reduction in investment in new cures and drugs at the worst possible time. We are all relying on America’s pharmaceutical innovators at this critical time.” – Neil Bradley, Executive Vice President and Chief Policy Officer, U.S. Chamber of Commerce
     
  • Today, September 15, at 12:00 PM the FDA will host a webinar to review enforcement policy for gowns, other apparel, and gloves during the COVID-19 pandemic and umbrella EUA for gowns and other apparel. During this webinar, the FDA will present information on both the enforcement policy and the EUA for gowns and other apparel, and representatives from the FDA, CDC, and OSHA will be available to answer questions.  
  • The NIH announced results from an agency-funded study which indicate that people with substance use disorders (SUDs) are more susceptible to COVID-19 and its complications. The research was co-authored by Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA). According to the authors, the study findings underscore the need to screen for, and treat, SUDs as part of the strategy for controlling the pandemic. Additional research needs to be done to better understand how best to treat those with SUDs who are at risk for COVID-19 and counsel on how to avoid the risk of infection.
  • 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 16, 12:15 PM
    • September 23, 12:15 PM
    • September 30, 12:15 PM
  • FDA test figures remain the same with 247 tests authorized by FDA under EUAs, including 197 molecular tests, 46 antibody tests, and 4 antigen tests.
  • OSHA has published guidance on the use of cloth face coverings while working in both indoor and outdoor hot and humid conditions. 
  • The Senate Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will meet this Wednesday, September 16, for a hearing at 10 AM titled, "Department of Health and Human Services’ Coronavirus Response: A Review of Efforts To Date and Next Steps."
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 6,503,030 total cases and 193,705 deaths The CDC data closes out the day before reporting. 
  • South Carolina’s lieutenant governor, Pamela Evette, has tested positive for COVID-19. She reports that she has only had mild symptoms and began quarantining last week.
  • States that reopened bars have experienced a doubling in the rate of cases after three weeks.
  • Statewide data in Michigan show 280 COVID-19 infections linked to several school clusters.
  • Wisconsin is reporting its highest level of new daily cases during the pandemic, averaging more than 1,000 new cases a day over the last week. The increases are largely tied to college towns.
  • Los Angeles began its sweeping initiative to test and screen all 700,000 students and 75,000 employees in the Los Angeles public schools. Officials reported five cases last week out of more than 5,400 children and adults tested.
  • New York City Mayor Bill de Blasio said that about 17,000 public school staff members have been tested ahead of the first day of school on September 21, and 55 have tested positive for COVID-19. Starting in October, the city will require monthly, random testing of 10 to 20 percent of students and staff members in all school buildings.
  • Minnesota Gov. Tim Walz (D) signed an EO extending the COVID-19 peacetime emergency.
  • The Illinois Department of Public Health reported that 30 counties in the state are considered to be at a warning level for COVID-19.
  • Colorado Gov. Jared Polis (D) extended his EO directing Coloradans to wear a face mask.
  • Mississippi Gov. Tate Reeves (R) also extended the mask mandate in his state. 
  • Washington Gov. Jay Inslee (D) announced updated guidance for indoor fitness and training facilities as part of Washington's Safe Start phased reopening plan.
  • A federal judge ruled recent EO's by Pennsylvania Gov. Tom Wolf (D) to be unconstitutional. The orders placed size limits on indoor gatherings and closed non-essential businesses.
  • Delaware Gov. John Carney (D) announced that the state will shift COVID-19 testing from mobile to fixed sites beginning Monday, September 14. The transition to more permanent, fixed testing sites will expand testing opportunities and provide more testing locations across the state.
  • Connecticut Gov. Ned Lamont (D) announced that his administration, working in collaboration with Spectra Venue Management services, has reached an agreement with Major League Soccer’s Toronto FC to play its home games this season at Pratt & Whitney Stadium at Rentschler Field in East Hartford.
  • 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
  • Here is the most recent (9/14) edition of the WHO's Weekly Epidemiological Update.
  • Monday, the WHO reported the highest one-day increase in COVID-19 infections since the start of the pandemic with more than 308,000 new cases.
  • Antarctica remains the only continent with zero cases of COVID-19, but that could change as researchers begin to arrive.
  • French cities Marseille and Bordeaux have imposed bans on gatherings of more than 10 people after authorities noted a concerning surge of cases in the cities and surrounding areas. Visits to retirement homes will also be more restricted.
  • The U.S. has relaxed its travel advisory for China and Hong Kong but is still warning Americans to “reconsider travel." In its updated guidance, the government said China and Hong Kong had resumed most business operations.
  • Former Italian prime minister, Silvio Berlusconi, has left the hospital after nearly two weeks. He was previously admitted to be treated for pneumonia caused by COVID-19. He made an effort to warn Italians not to underestimate the gravity of the virus. 
  • India reported 92,071 new cases today, the fifth consecutive day that new cases exceeded 90,000 in the country.
  • British officials set stricter restrictions on gatherings, lowering the limit of people who can meet from 30 to six.
  • Dr. Jeannette Young, the chief health officer of Queensland, is under police protection because of death threats amid rising opposition to her pandemic policies. This is not an isolated case. Public health authorities around the world are facing death threats from people who are upset with their proposed restrictions. 
  • Israel will be returning to a nationwide lockdown for at least three weeks, starting on Friday.
  • On Saturday, Canada reported zero COVID-19 deaths for the first time since March 15. 
  • Global Cases: 29,306,931      Total Deaths: 929,026
Lifestyle, Science, and Economy
  • According to the Organization for Economic Cooperation and Development, the damage to the world’s major economies from pandemic lockdowns has been six times more severe than the 2009 global financial crisis and created an “unprecedented” blow to growth in the second quarter in almost every country except China. Growth in the U.S. shrank by 9 percent. 
  • AstraZeneca’s vaccine trials have resumed in Britain after a recent clinical hold and safety review. Trials remain paused in the U.S. and other countries.
  • Pfizer and BioNTech said they are moving to enlarge the Phase 3 trial of their COVID-19 vaccine by 50 percent, which could allow the companies to collect more safety and efficacy data and to increase the diversity of the study’s participants. The companies said they want to increase the size of the study to 44,000 participants, which would have to be approved by the FDA.
  • Merck has begun testing one of its COVID-19 vaccine candidates in humans. Check the links below for a variety of vaccine trackers. 
  • Several K-12 school districts in the U.S. Northeast have delayed the start of in-person classes in recent days after high school students attended large parties, leading to concern about increased spread of the virus.
  • This year's Macy’s Thanksgiving Day Parade will be confined to the Herald Square area and broadcast for viewers to watch. The balloons and floats will approach from 34th Street and Sixth Avenue, move along 34th Street in front of the Macy’s building, and then turn the corner onto Seventh Avenue and out of view.
  • The Smithsonian American Art Museum, the National Portrait Gallery, the National Museum of African American History and Culture, and the Renwick Gallery are all scheduled to reopen on Friday.
  • Amazon announced it plans to hire 100,000 new workers in the U.S. and Canada for its warehouses and logistics network.
  • A recent survey of more than 400 employers in D.C., Maryland, and Virginia shows most are struggling with how to safely bring back workers in the midst of the pandemic, even as states continue to reopen.
  • 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 includes peer-reviewed articles from PubMed and preprints from medRxiv, bioRxiv, ChemRxiv, and arXiv. It 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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