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COVID-19 Update
June 18, 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,  24,639 Iowans have tested positive, up 376 from our update yesterday morning, with a total of 238,628 tested.  7 more deaths were reported since our update yesterday, bringing the total to 677 deaths. Now 15,409 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
Timeline/Process/Politics: All signs seem to be pointing to movement on a bill happening in the middle, or more likely, the end of July. No real discussion between parties is happening at this point and there’s no set process for moving forward. We are still in wait-and-see mode.
 
Policy: As negotiations over what priorities will be making it into the next bill have yet to begin, what policies are included remain remarkably foggy. Democrats have outlined their main priorities in the Heroes Act (though conditions and the COVID-19 landscape has changed significantly since that bill passed the House).

In the liability protection space, Reps. Graves (R-LA) and Cuellar (D-TX) plan to introduce a bill (the Get America Back to Work Act) that would outline liability protections for employers. Text here. Highlights include:
  • Preemption of state laws, unless they provide greater liability protections.
  • General liability protection for businesses, nonprofits, and other organizations that “make a reasonable effort” to comply with CDC and local (state, territory, tribal) public health authority guidance.
  • Protection is granted between 1/1/2020 and 18 months after the COVID-19 emergency ends.
  • The exceptions include harm caused by:
    • Willful or criminal misconduct,
    • Gross negligence,
    • Reckless misconduct, and
    • Conscious flagrant indifference to rights or safety of the individual harmed.
  • The bill sets out specific protections and exceptions for health care professionals.
Legislation to Watch
The Prioritized Paycheck Protection Program (P4 Act)
Sens. Cardin, Coons, and Shaheen plan to introduce the Prioritized Paycheck Protection Act or P4 Act today. The bill would allow some small businesses to receive a second Paycheck Protection Program loan. Text here. One-pager here. Section by section here.
 
Under the bill, forgivable PPP loans would be available to small businesses and nonprofits who are still suffering from the pandemic/recession.  Highlights below:
  • Eligible applicants would either be self-employed or have 100 or fewer employees AND show business activity is still down at least 50 percent. To be eligible, applicants must have already completely used a PPP loan (or be on pace to exhaust it).  
  • Loans would be capped at $2 million or 250 percent of monthly payroll costs.
  • Loans would not be available to publicly traded companies.
Passed Legislation
New Implementation Information and Guidance
  • 6/17 – SBA and Treasury announced an updated forgiveness application for the Paycheck Protection Program. Treasury press release here. EZ Forgiveness Application here. Full Forgiveness Application here. The new application, called the “EZ version”, can be used by borrowers that are:
    • Are self-employed/have no employees; OR
    • Did not reduce salaries/wages of employees by more than 25% AND did not reduce the number or hours of employees; OR
    • Did not reduce salaries/wages of employees by more than 25% AND experienced lower business activity from health precautions related to the pandemic.
  • 6/16 – The Federal Reserve Board announced it would seek public feedback on a proposal to allow nonprofits to be part of the Main Street Lending Program. Treasury press release here.
Congress
Hearings/Floor Activity
The House will be in session next week, with votes on June 25 and 26. The House will have votes on the Democratic police reform bill (Justice in Policing Act) and a DC statehood bill. Sen. Tim Scott (R-SC) released the Republicans’ police reform bill today (the JUSTICE Act) and Rep. Pete Stauber (R-MN) will be releasing its companion bill in the House soon.
 
Appropriations
The House plans to hold all the subcommittee markups on July 6 and 7, with full committee markups beginning July 9. With this condensed schedule, there will likely be two or three markups each day. The plan is to finish full committee markups by Thursday, July 16. The markups will be conducted in the Ways and Means Committee room to allow space for social distancing. The order of bills has yet to be finalized.
 
The plan also remains to move bills on the floor the last two weeks of July in the form of two minibuses. It’ll be a relatively closed floor process with a limited number of votes per package, as voting takes so long. The Rules Committee may package amendments enbloc as a part of a rule.
 
The Senate markups have slipped, possibly slipping to early July. A Republican aide said the delay was caused by Democratic amendments that complicate bipartisan support for the bills. The subcommittee markup schedule has been reported as E&W, THUD, and Leg Branch on June 25; Interior, CJS, Ag, DHS on July 2; and the remaining bills to be determined. SAC is unlikely to markup the Homeland Security and MilCon/VA bills. SAC-D will likely not markup prior to August recess and may have to post a Chairman’s mark. Subcommittees will poll their member rather than meet in person and save the in-person markups for full committee, to minimize the number of times that committee members have to gather.

NDAA
While the Senate Armed Services Committee approved the FY21 NDAA last Thursday, the Committee has yet to file the bill. Originally intended to file on Monday, but that’s been delayed until next week.
 
The House Armed Services Committee is scheduled to markup next week, with the full committee markup on June 24. The aim is to have the bill move on the House floor before August recess.
 
House Protocols
The Chief Attending Officer and Attending Physician of the House sent out new guidance for offices. The guidance states that offices can receive Plexi-glass and PPE for no cost.
 
The House Attending Physician Brian Monahan sent out updated guidance in a Dear Colleague last night. The guidance requires face coverings for those meeting in “enclosed space[s]” for longer than 15 minutes. Speaker Pelosi has asked committee chairs to invoke rules on decorum to prevent members without masks from taking part in hearings.
 
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (1): Rep. Tom Rice (R-SC)
Recovered (7): 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)
Currently Self-Quarantined (0):
Completed Quarantine (38): 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
  • House Speaker Nancy Pelosi (D-CA) has asked committee leaders to invoke the chamber’s rule on decorum to prevent members who choose not to wear face coverings from taking part in hearings within the committee meeting rooms. House lawmakers are now required to wear masks during in-person committee meetings, but it will be up to the chairmen and chairwomen of those panels to decide on enforcement. The decision comes on the heels of updated guidance from attending physician Brian Monahan. 
  • Yesterday, the FDA published the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry. Clinical trials and development across investigational product areas have been impacted by public health measures to control the COVID-19 virus; this guidance shares recommendations on statistical considerations to address the impact of COVID-19 on meeting objectives of clinical trials. This guidance applies to clinical trials of human medical products and animal drugs.
  • The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents. This page answers questions about adverse event reporting for medical devices distributed under EUAs or that are the subject of COVID-19-related guidance documents and points out a number of adverse event reporting-related resources.
  • The FDA posted template updates regarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.
  • Yesterday, the Federal Housing Administration (FHA) announced a two-month extension of its foreclosure and eviction moratorium through August 31st, for homeowners with FHA-insured Single Family mortgages. This extension provides additional security and peace of mind to homeowners that they will not lose their homes while they are trying to recover financially from COVID-19.
  • The CDC continues to update its dashboard with new guidance documents and details. Yesterday, the agency updated information about how the virus spreads, added additional resources to guide decisions about errands and going out, and revised the contact tracing page to incorporate COVIDTracer: A spreadsheet-based tool that allows state- and local-level public health officials and policy makers to compare between three different contact tracing/monitoring strategies.
  • The Department of Education issued an interim final rule for institutions of higher education to determine which individuals attending their institution are eligible to receive emergency financial aid grants to students under the CARES Act.
  • The following COVID-19 hearings are slated to place in Congress this week:
    • Wednesday (6/17) 10 AM Senate HELP, "Hearings to examine telehealth, focusing on lessons learned from the COVID-19 pandemic."
    • Wednesday (6/17) 11:30 AM House Energy and Commerce, "Health Care Inequality: Confronting Racial and Ethnic Disparities in COVID-19 and the Health Care System."
    • Thursday (6/18) 9:30 AM Senate Foreign Relations, "COVID-19 and U.S. International Pandemic Preparedness, Prevention, and Response."
    • Thursday (6/18) 4 PM House Homeland Security, "Climbing Again: Stakeholder Views on Resuming Air Travel in the COVID-19 Era.”
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 2,132,321 total cases and 116,862 deaths The CDC data closes out the day before reporting. 
  • It took only three weeks for Arizona to double from 20,000 cases of COVID-19 to 40,000 cases. 
  • Gov. Andrew Cuomo (D) announced that New York City is on track to enter phase two of reopening on June 22nd. The Mid-Hudson Valley is on track to enter phase three of reopening on June 23rd, and Long Island is on track to enter phase three of reopening June 24th based on current data.
  • Colorado Gov. Jared Polis (D) announced a new round of Safer at Home guidelines that include residential summer camps, indoor and outdoor events, bars, personal services, and non-critical manufacturing facilities. The new guidelines will be open for comment for 48 hours and will be finalized on Thursday, June 18th.
  • Connecticut Gov. Ned Lamont (D) signed an EO modifying previous orders to adapt to phase two reopening efforts to begin on June 16th. He also announced updated guidance for indoor and outdoor gatherings over the next several weeks.
  • Kentucky Gov. Andy Beshear (D) offered updated guidance on public pools and gatherings of up to 50 people.
  • Gov. Phil Murphy (D) and the New Jersey Department of Health issued guidance on safety protocols for outdoor organized sports activities which are set to resume as of June 22nd. The guidance permits practices and competitions for low-risk sports that do not involve contact and modified no-contact practices for medium-risk and high-risk sports.
  • Arizona Gov. Doug Ducey (R) granted permission to local authorities to require face coverings in public. 
  • Useful state data:
    • The NYT is tracking which states are reopening and which are still shut down.
    • These charts show cumulative coronavirus cases and deaths for metropolitan areas over time.
    • 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
  • Beijing canceled 70 percent of commercial flights from two of its major airports in an effort to contain a new outbreak that has infected more than 130 people in the past five days. 
  • Russia's Health Ministry said today that they have begun clinical trials of a COVID-19 vaccine.
  • Australian Trade Minister Simon Birmingham said Australia is unlikely to reopen its border to international travelers until 2021, but will look to relax entry rules for students and other long-term visitors.
  •  Two Australian universities plan to hire a plane to fly in hundreds of foreign students shut out in the middle of their studies by border closures due to COVID-19, a move they hope will start to salvage a major export earner. 
  • Juan Orlando Hernández, the president of Honduras, has tested positive for COVID-19. In addition, he announced that the first lady and two aides have also tested positive.  
  • Brazilian health authorities said they will now recommend hydroxychloroquine to treat COVID-19 in children and pregnant women. They criticized the U.S. FDA's recent decision to revoke the emergency use of the drug. 
  • Panama’s civil aviation authority said it will extend a suspension of international flights by a month due to the pandemic. The additional month of suspended flights begins on June 22nd and will run through July 22nd. 
  • India recorded its highest single-day toll as officials move to account for unreported virus deaths. Mumbai recorded 1,409 deaths on Tuesday, and the capital, New Delhi, added 437 fatalities, according to data from the federal health ministry. The country now has the eighth-highest death toll worldwide.
  • Germans will be required to register pets that contract COVID-19. Registration will help scientists studying the virus, according to the agriculture minister. 
  • The WHO announced on Wednesday that it was halting its major trial of hydroxychloroquine. Dr. Henao Restrepo, a WHO official, said the decision was based on evidence from the trial and from others conducted elsewhere that showed the drug “does not result in the reduction of the mortality of those patients.”
  • Global Cases: 8,373,746       Total Deaths:  449,512
Lifestyle, Science, and Economy
  • A recent Wall Street Journal article (free to read here) breaks down how, exactly, people catch COVID-19. One factor the article points out is that simple activities like speaking and breathing produce respiratory molecules that can disperse along air currents and potentially infect people nearby. 
  • Earlier this week, researchers described findings from a study that suggest the steroid dexamethasone could be effective at reducing COVID-19 mortality. The drug is part of the RECOVERY clinical trials conducted in the United Kingdom, one of the largest clinical trials testing potential COVID-19 therapeutics. The preliminary results have not undergone peer review. The study tested a small daily dose of the drug in 2,104 hospitalized COVID-19 patients. When compared to a non-placebo-controlled control group who received the normal standard of care, dexamethasone was associated with a 34 percent decrease in mortality for patients on mechanical ventilation and 20 percent decrease for those receiving oxygen therapy.
  • Federal Reserve Chairman Jerome Powell said recent economic improvement could be jeopardized if Congress curtails support to workers and businesses impacted by COVID-19. Mr. Powell said 25 million workers remain dislodged from their jobs.
  • A study published in CDC's Morbidity and Mortality Weekly Report implies that, to reduce severe outcomes from COVID-19, measures to prevent infection with SARS-COV-2 should be emphasized for persons at highest risk for hospitalization with COVID-19.  Data for 220 hospitalized and 311 nonhospitalized COVID-19 patients from six metropolitan Atlanta hospitals and associated outpatient clinics found that older age, black race, diabetes, lack of insurance, male sex, smoking, and obesity were independently associated with hospitalization. In fact, nearly 80 percent of patients hospitalized in Atlanta because of COVID-19 were Black.
  • The English Premier League resumed today after a three month hiatus. 
  • Target is raising its starting wage to $15 an hour, making it the first major retailer to permanently increase pay during the pandemic.
  • The WHO keeps a running list of COVID-19 vaccine candidates, which you can view here. They are now reporting 133 potential vaccines, 10 of which are in clinical trials in the U.S., U.K., and China. 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.
  • RetailDive tracks store reopenings in the U.S. 
Helpful Articles/Media
Please contact me directly with any questions and I would be happy to assist.

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 Biotechnology Association, All rights reserved.


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