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COVID-19 Update
July 28, 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,  42,700 Iowans have tested positive, up 342  from our update Friday morning, with a total of 458,143 tested.  7 additional deaths were reported since our last update, bringing the total to 836 deaths. Now 30,476 Iowans have recovered. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.

Federal Legislation
Supplemental IV – The HEALS Act
Timeline: After White House Chief of Staff Mark Meadows and Treasury Secretary Steve Mnuchin met with Senate leaders over the weekend to review the details of the bill, the Senate Republican bill was released late Monday afternoon. Speaker Nancy Pelosi released a statement calling on Republican leadership to meet in her office within 30 minutes of releasing their bill to begin negotiations. Negotiations will be neither quick nor painless. Expect a House vote in August, though, whether that will be before or after the Paycheck Protection Program expires (August 8) is unclear.
 
Process/Politics: The White House will likely continue to be represented by Secretary Mnuchin and Chief of Staff Meadows, while Congressional Republicans will have Leader McConnell and Leader McCarthy. Speaker Pelosi and Leader Schumer will continue to lead on the Democratic front; However, with this many people directly involved in brokering a deal, expect this negotiation process to have lots of ups and downs before we reach a final deal.
 
When a deal is reached – this time is different – it is unlikely to be unanimous or garner broad support. Senator Lindsey Graham has indicated that 20 or more of his Republican colleagues are unlikely to vote for any package. If package gets to certain size, other Republicans (though it’s unclear how many) will vote against as well.
 
Democrats have moved in the opposite direction from Republicans since Heroes was passed. While the Republican bill stands at $1 trillion, the Heroes Act clocked in around $3 trillion. Because of the delay in passing another bill, Democrats believe more money (in the ballpark of $4 trillion) is necessary to adequately address the pandemic and economic downturn. Whether certain Democratic priorities are included depends on how much space is leftover after priorities both parties agree on are included. It seems Republicans and Democrats are on the same page for including a significant amount of funding for education and health. It’s unclear how much more money would be available for other priorities – state/local/tribal funding, broadband, housing relief – before leadership starts to lose enough Republican votes to endanger passage.
 
There are still rumblings around passing a standalone short-term extension for unemployment insurance as the deadline nears. Democrats, however, view that proposal as a nonstarter as they see it as a way to deflect from the failure of Republicans to begin negotiations earlier (and release a bill earlier). It is unclear if this will go anywhere as the pressure mounts this week.
 
Policy: Senate Republicans released the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act yesterday, which represents the first step in a multi-step process toward a final bill. The bill is around $1 trillion, with a third dedicated to appropriations, a majority of which is under the Labor-HHS subcommittee. Expect significant changes from this draft to the final bill, as text has yet to be negotiated with Democrats. The bill was released in sections by various senators. See below for text and summaries of the sections below.
  • Appropriations (text here, summary here)
    • $118 for HHS, including:
      • $16 billion for testing (you might see this cited at $25 billion, but that includes unallocated funding from COVID 3.5),
      • $26 billion for vaccines development distribution (BARDA and CDC),
      • $25 billion for provider relief fund,
      • $15 billion for child care (“Back to Work Child Care Grants” HELP one pager here),
      • $15.5 billion for NIH,
      • $4.5 billion for SAMHSA,
      • $3.4 billion to CDC, and
      • $7.6 billion for Community Health Centers.
    • $105 billion for Department of Education
      • $70 billion for K-12, though two-thirds of it will be reserved for aiding schools in reopening and will be rewarded based on certain reopening requirements.
      • $29 billion for higher education, though institutions that paid endowment taxes in 2019 can only use the funding for student aid.
      • $5 billion for the Governors Emergency Education Relief Fund;
      • $1 billion for BIE.
    • $20 billion for Agriculture-FDA,
    • $29 billion for Defense,
    • $3 billion for Homeland,
    • $13 billion for THUD, and
    • $4.4 billion for SFOPS.
  • Liability protections (Text here)
    • Creates liability for a broad range of organizations that mandate plaintiffs show defendants were grossly negligent/engaged in willful misconduct AND violated public health guidelines.
  • Small Business (Press release here, text here, section by section here, one pager here)
    • Extends the Paycheck Protection Program,
    • Allow businesses with fewer than 300 employees that had seen revenue decline by 50 percent or more in Q1/Q2 to receive a second PPP loan. Includes a set aside within the program for those with 10 or fewer employees and $10 billion set aside for community lenders.
    • Expands eligibility to 501(c)(6) organizations that either:
      • have fewer than 50 employees and limited lobbying activity, OR
      • are Chambers of Commerce or Destination Marketing Organizations with 300 or fewer employees.
    • Forgiveness to include other costs like PPE, safety supplies, and other expenses.
    • Streamlined forgiveness for loans under $150k.
    • Creation of working capital loan for businesses with fewer than 500 workers and have seen revenue decline by 50 percent or more (as an alternative to PPP second round).
  • Senate Finance Committee (text here, section by section here)
    • Extension of enhanced unemployment insurance. After July 31, would provide $200 a week until October, when benefits would then be capped (when combined with state contribution) at 70 percent of an individual’s lost wages.
      • Note: One Democratic (House) option was advanced in the HEROES Act (extension of the full $600 per-week expansion into Jan/March 2021), while another option gaining increasing momentum would be to tie UI extension to underlying economic metrics to eliminate the need for Congress to act to see future extensions and increases. 
    • Another round of direct payments to individuals. Those eligible make less than $75k, are not dependents, and those with a work eligible social security number (i.e. can work in the U.S. legally). An additional $500 will go to taxpayers with dependents (of any age).
    • Tax provisions, including:
      • Enhanced employee retention tax credit (from 50 percent of wages to 65 percent);
      • Adds COVID-19 unemployment recipients as a targeted group to the work opportunity tax credit (WOTC), which provides a tax credit to employers that hire individuals from certain groups;
      • PPE tax credit (refundable payroll tax credit equal to 50 percent of what an employer spends on “employee protection”);
      • Mandates that through 2024, employees performing work in multiple states will only be subject to income tax in their state of residence; and
      • Business meals deduction (text here, Sen. Tim Scott).
    • Health provisions, including:
      • Part B premium freeze until 2022;
      • Extension of telemedicine reimbursement either through 2021 or the end of the public health emergency; and
      • Extended timeline for providers to repay Medicare Accelerated and Advance payment loans.
    • Certain flexibilities and limitations on Coronavirus Relief Fund payments to state, local, and tribal governments (no additional funding for state/local/tribal governments):
      • Extends the timeline for spending the funds to 90 days after the last day of FY21,
      • Allows states to use the funding to make up lost revenues, and
      • Prohibits the use of funding for pensions/rainy-day funds.
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 (1): Rep. Morgan Griffith (R-VA)
Currently Self-Quarantined (0):
Recovered (8): 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)
Completed Quarantine (39): 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)

Other Federal Actions
  • Pharmaceutical companies cancelled a meeting slated today with President Trump after he issues a series of executive orders Friday, including a significant most favored nation price setting regime for Medicaid, which many fear will harm drug companies combating COVID-19. For more read Politico’s take here. The STAT News report on the EOs is here. BIO’s reaction to the EOs is here. PhRMA’s reaction here. The Executive Orders are here.
  • President Trump’s national security adviser, Robert O’Brien, has tested positive for COVID-19. He is the most senior White House official known to have contracted the virus.
  • The Moderna/NIH vaccine candidate has entered a Phase 3 clinical trial. The trial, which will be conducted at 89 U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19. Read more here
    • If you're interested in learning more about all of the vaccine candidates, the New York Times has a very helpful tracker to follow vaccine development. It contains a list of 19 of the most-talked-about treatments for COVID-19.
    • BIO’s pipeline tracker for vaccines, antivirals, and treatments is here.
  • The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing. The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand use of the test to anyone, after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population. Additionally, the reissuance includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation. Sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more samples to be evaluated quicker.
  • The FDA continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has posted a do-not-use list of dangerous hand sanitizer products, which is being updated regularly.
  • HHS reserved the available advanced manufacturing capability and capacities of the Center for Innovation in Advanced Development and Manufacturing (CIADM) at the Texas A&M University System for use in manufacturing COVID-19 vaccines. The task order to the CIADM includes accelerating expansion of that manufacturing capacity for potential COVID-19 vaccines. The approximately $265 million task order falls under an existing agreement with BARDA. The CIADM is a public-private partnership between BARDA and the Texas A&M University System with manufacturing subcontracted to FUJIFILM Diosynth Biotechnologies.
  • Today at 2 PM the CDC will hold a Clinician Outreach and Communication Activity (COCA) Call on COVID-19 and Diabetes: The Importance of Prevention, Management, and Support.
  • On July 29 at 12:15 PM, 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.
  • Also on July 29, at 3 PM, the CDC will host a webinar on "COVID-19 Response: Promising Practices in Health Equity II." Register here
  • The CDC recently released a Morbidity and Mortality Weekly Report on underlying medical conditions associated with an increased risk for severe COVID-19 related illness. The report defines severe COVID-19 illness as requiring hospitalization, ICU, or mechanical ventilation or resulting in death. The risk of associated illness increases with age and the presence of underlying conditions. For those individuals with underlying medical conditions, the report determined that hospitalizations were 6 times higher, ICU admissions were 5 times higher, and deaths were twelve times higher than those without underlying medical conditions.  
  • The CDC continues to update its dashboard with new guidance documents and details, and I highly encourage exploring the newest toolkits. A few of the most recent additions include:
  • The following are COVID-19-related hearings in Congress this week:
    • Tuesday (7/28) 10 AM Senate Homeland Security, "An oversight hearing to examine COVID-19 financial relief packages."
    • Tuesday (7/28) 10:15 AM Senate Finance, "Hearings to examine protecting the reliability of the United States medical supply chain during the COVID-19 pandemic. Pt. 1."
    • Tuesday (7/28) 2:30 PM Joint Economic Committee, "Hearings to examine reducing uncertainty and restoring confidence during the Coronavirus recession."
    • Wednesday (7/29) 10 AM House VA, "Who's in Charge? Examining Oversight of State Veterans Homes During the COVID-19 Pandemic."
    • Wednesday (7/29) 10 AM Senate Environment and Public Works, "Hearings to examine lessons learned from remote working during COVID-19, focusing on if the government can maximize use of leased space."
    • Wednesday (7/29) 2:30 PM Senate Indian Affairs, "An oversight hearing to examine preparing to head back to class, focusing on how to safely reopen Bureau of Indian Education schools."
    • Wednesday (7/29) 3 PM Senate VA, "Hearings to examine VA telehealth during and beyond COVID-19, focusing on challenges and opportunities in rural America."
    • Thursday (7/30) 9:30 AM Senate Finance, "Hearings to examine protecting the reliability of the United States medical supply chain during the COVID-19 pandemic. Pt. 2."
    • Friday (7/31) 9 AM House Oversight, "The Urgent Need for a National Plan to Contain the Coronavirus."
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 4,225,687 total cases and 146,546 deaths The CDC data closes out the day before reporting. There have now been more than 4 million cases of COVID-19 reported in the U.S. 
  • Washington, D.C. Mayor Muriel Bowser said travelers should quarantine for 14 days if they arrive from 27 “high-risk” states that meet certain criteria, including California, Florida, and Texas. Residents from Maryland and Virginia are exempted from the order. 
  • Delaware Gov. John Carney (D) signed a modification to his State of Emergency declaration, allowing driver education services to resume immediately, with safety measures in place to prevent transmission of COVID-19. Gov. Carney’s modification also allows senior centers to open with safety precautions at 30 percent capacity.
  • Colorado Gov. Jared Polis (D) signed an EO extending the temporary suspension of certain regulatory statutes due to COVID-19, including statutory license limitations for breweries, wineries, distilleries, and retailers licensed for on-premises alcohol consumption. 
  • California Gov. Gavin Newsom (D) announced a new program, Housing for the Harvest, that will provide safe, temporary isolation spaces for agricultural and farmworkers who test positive or were exposed to the virus, which limits the risk of spreading COVID-19 to their coworkers or households. The program will operate in partnership with counties and local partners in the Central Valley, Central Coast, and Imperial Valley – the regions with the highest number of agricultural workers.
  • The New Jersey Department of Education issued clarifying guidance to allow parents to select full time remote learning for their children in the 2020-2021 school year.  
  • Kentucky Gov. Andy Beshear (D) ordered the state’s bars to close only a month after they reopened and reduced legal restaurant capacity from 50 percent to 25 percent.
  • Useful state data:
    • NPR tracks where coronavirus cases are on the rise. 
    • 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 resource from Bloomberg Law is a database of State Quarantine and Public Health Laws related to the COVID-19 response.
    • 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.
    • Finally, this site offers COVID-19 projections assuming full social distancing and can be broken down by state.
International Affairs
  • North Korea announced the country’s first suspected case of COVID-19. According to North Korean state media, the case was identified in an individual who had previously defected to South Korea and recently crossed the border back into North Korea. The individual reportedly exhibited symptoms associated with COVID-19, but there are currently no reports that the individual has tested positive.
  • Spain is no longer on the U.K.'s travel corridor list and people arriving into England, Wales, Scotland, and Northern Ireland from Spain will be required to self-isolate.
  • Hong Kong will prohibit dining in restaurants, limit public gatherings to two people, and require mask-wearing in public at all times, reacting to a spike in coronavirus cases.
  • COVID-19 cases in Latin America for the first time have surpassed the combined infections in the U.S. and Canada, amid a surge of infections in Brazil, Mexico, Peru, Colombia, and Argentina.
  • Nearly two weeks after being hospitalized for COVID-19, the health minister of the Mexican state of Chihuahua, Jesus Grajeda, has died.
  • Belgium is tightening restrictions following an increase in COVID-19 cases. Starting Wednesday, Belgians will be allowed to see a maximum of five people outside of their families. Currently, a Belgian individual can meet 15 people in a "social bubble." 
  • Vietnam is evacuating 80,000 people, mostly local tourists, from Danang after three residents tested positive for COVID-19 over the weekend.
  • 15 lawmakers in Zambia have tested positive for COVID-19. 
  • Global Cases: 16,495,309        Total Deaths:  654,327
Lifestyle, Science, and Economy
  • About 4,000 federal employees are seeking disability compensation on grounds that they contracted COVID-19 at work, while survivors of 60 deceased employees are seeking death benefits for the same reason. The Department of Labor is far behind in processing claims, and the number of claims is expected to significantly increase over the next few weeks.
  • Gold reached a record high yesterday, continuing its rise as nervous investors sought out a safe place to put their money. The price for spot gold, which has been climbing steadily since March, reached $1,944 per ounce.
  • Google’s employees will work from home until mid-2021.
  • Planet Fitness announced yesterday that all guests will be required to wear masks at all times while inside its facilities, effective August 1. 
  • Two coaches and 12 players on the Miami Marlins have tested positive for COVID-19, leading to the cancellation of multiple Major League Baseball games this week. 
  • 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
  • Continue to look at 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. 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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