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COVID-19 Update
September 1, 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, 65,259 Iowans have tested positive, up 661 from our update Friday morning, with a total of 635,999 tested.  9 additional deaths were reported since our last update, bringing the total to 1121 deaths. Now 47,371 Iowans have recovered. Numbers of those hospitalized and in the ICU are trending upward. 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.

Federal Legislation
Supplemental IV
Timeline: It seems that talks remain at a standstill. After a fruitless phone call between Speaker Pelosi and White House chief of staff Meadows last week, there are little to no bipartisan conversations happening. Some have predicted that after the nominating conventions ended, bipartisan talks would resume—we have yet to see that take place. It seems the soonest negotiations would begin again would be next week once the Senate is back in session (and the House is holding its Committee Work Days). Depending on when talks resume in earnest, it is hard to see how a package could come together very quickly.
 
Last week there was a persistent rumor that the House would put together and introduce a Democratic “skinny bill” with at topline of $2.2 trillion, which was the topline Speaker Pelosi had offered to Republicans last week. However, House appropriators have been directed to not begin compiling and drafting anything until a topline agreement is reached and there is consensus on the main big-ticket items.
 
Process/Politics: While some vulnerable House Democrats may be calling on Pelosi publicly to make a deal soon, Democrats seem to remain relatively unified behind Speaker Pelosi’s negotiating strategy. Leader McConnell has continued to hear from the vulnerable members in his conference, but has shown no movement yet.
 
With the expiration of the expanded unemployment insurance provision continuing to cause economic pain for constituents, rents being due at the end of the month (today), and the continued delays and problems at USPS, the pressure for both sides to work towards a deal will continue.
 
That pressure will only increase as the end of the fiscal year on September 30 looms. It seems that leaders will need to either 1) come to an agreement in early September on the next COVID-19 bill and then later in the month pass a continuing resolution (CR) before fiscal year 2020 funding runs out on September 30, or 2) combine the CR and COVID-19 bill into one large package and pass it later in September. If they do not pass a CR by September 30, the government will shut down.  An unfortunate but possible alternative scenario is that 3) Congress has reached no agreement and either allows a shutdown or may fall back on short-term clean extensions of government funding to buy more time for additional negotiations.
 
Last week, Meadows said the White House was supportive of adding a continuing resolution (CR) on to whatever coronavirus package passes. Appropriations staff have already begun outreach to agency staff to discuss necessary anomalies, as funding runs out at the end of September. Speaker Pelosi has supported keeping the CR and coronavirus legislation on separate tracks.
 
Policy: Senate Republicans have begun whipping on the draft bill they released earlier in August, which may now include a childcare component originally introduced in the Republican’s HEALs Act. It’s unclear whether the Senate will vote on the bill and if so, whether it will even pass, as Democrats will likely vote against. Notably, Democrats in the House passed the Heroes Act mid-May and Senate Republicans have yet to unify around a bill. When HEALs was introduced, Senate leadership indicated that almost half the Senate Republican Conference would not vote for it. Passing or working toward passage of a bill that Republicans agree on could create added leverage (or at least stability) for Republicans in negotiations. 
 
On August 18, Senate Republicans released a draft bill, which was pared down considerably from what they included in HEALs.  The bill would include funding for unemployment insurance through the end of the year, funding for the Paycheck Protection Program, liability protections, and health and education funding. It does not include individual stimulus payments, the non-Labor HHS appropriations included in HEALS, and tax incentives. Notably, there is no inclusion of Democratic priorities like funding for state/local/tribal governments and childcare (among other things). Text of the draft Delivering Immediate Relief to America’s Families, Schools and Small Businesses Act here. Highlights include:
  • Provides liability protections to businesses and healthcare providers;
  • Provides $300 per week in enhanced unemployment insurance through the end of the year;
  • 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;
  • $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);
  • $29 billion for vaccine and treatment development and distribution;
  • $16 billion for testing/contact tracing; and,
  • $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.
On August 22, the House passed the Delivering for America Act (H.R. 8015) by a vote of 257-150. Text here. Highlights include:
  • Prohibition of any changes to policies and operating procedures – revert to the policies that existed on January 1, 2020.
  • Prohibition of the closing of Post Offices, other facilities, and “Blue Boxes”.
  • Disallow the prohibition of overtime.
  • Mandate that all elections mail is treated as First Class.
  • $25 billion for emergency funding to ensure the above provisions are executed.
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.
 
Passed Legislation
New Implementation Information and Guidance
  • 8/27 – SBA released updated data on the EIDL program and updated Agricultural loans and EIDL FAQs. EIDL data here. FAQ here.
  • 8/27 – HHS announced it had distributed $2.5 billion of a planned $5 billion distribution to nursing homes from the Provider Relief Fund program from CARES and following coronavirus supplementals.  The distribution went to over 15,000 nursing facilities. HHS has indicated that it plans to distribute an additional $2 bill later in the fall based on performance measures to be announced at a later date. Press release here. A state by state breakdown of the distribution can be found here.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (3): Rep. Jenniffer González-Colón (R-Puerto Rico at large), Rep. Dan Meuser (R-PA), Sen. Bill Cassidy (R-LA)
Currently Self-Quarantined (0): 
Recovered (12): 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 Velázquez (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)
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
  • Today, September 1, at 12 PM, the FDA and the CDC will host a webinar to review CDC/NIOSH’s Surgical N95 respirator guidance. During this webinar, CDC/NIOSH will present information on the guidance, and representatives from the CDC/NIOSH, FDA, and OSHA will be available to answer your questions.
  • The FDA announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on October 22 to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19. The FDA intends to make background material available to the public, including the meeting agenda and Committee roster, no later than two business days before the meeting. 
  • 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 9, 12:15 PM
    • September 16, 12:15 PM
    • September 23, 12:15 PM
    • September 30, 12:15 PM
  • The FDA alerted health care facility risk managers, procurement staff, and health care providers that medical gowns sold by Laws of Motion PPE, including surgical gowns, have potential quality issues that affect the level of fluid barrier protection and should not be used as personal protective equipment at this time. The Letter to Health Care Providers includes information for reporting problems with the Laws of Motion PPE gowns, including surgical gowns.
  • The FDA broadened the scope of the existing EUA for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, regardless of disease severity. 
  • The CDC continues to update online resources and guidance documents. Here are a few of the most recent updates:
  • Here is last week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
  • The NIH announced that AstraZeneca's COVID-19 vaccine candidate has entered Phase 3 trials. The trial will enroll approximately 30,000 adult volunteers at 80 sites in the U.S. to evaluate if the candidate vaccine can prevent symptomatic COVID-19. The Phase 3 trial is being implemented as part of Operation Warp Speed. Read more here
  • Agriculture Sec. Sonny Perdue announced that the USDA Farmers to Families Food Box Program has distributed more than 75 million food boxes in support of American farmers and families affected by the COVID-19 pandemic. Earlier last week, President Trump announced an additional up to $1 billion will be added to the Farmers to Families Food Box Program.
  • Sec. Perdue also announced the USDA will extend several flexibilities through as late as December 31 to allow summer meal program operators to continue serving free meals to all children into the fall months. This will help ensure that children continue to have breakfast and lunch during the COVID-19 pandemic. 
  • The GAO published a "Brief Update on Initial Federal Response to the Pandemic."
  • Negotiations for an additional pandemic relief bill are still stalled. For a more detailed description of what's on (or off) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe). 
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 5,972,356 total cases and 182,622 deaths The CDC data closes out the day before reporting. Other entities, such as Johns Hopkins, are now reporting over 6 million cases in the U.S.
  • Iowa, Kansas, Minnesota, and the Dakotas all added more cases in a recent seven-day stretch than in any previous week of the pandemic.
  • California Gov. Gavin Newsom (D) unveiled the Blueprint for a Safer Economy, a statewide, stringent, and slow plan for living with COVID-19 for the long haul. The plan imposes risk-based criteria on tightening and loosening COVID-19 allowable activities and expands the length of time between changes to assess how any movement affects the trajectory of the disease. 
  • The Illinois Department of Public Health has reported that 30 counties in Illinois are considered to be at a warning level for COVID-19. A county enters a warning level when two or more COVID-19 risk indicators that measure the amount of COVID-19 increase.
  • New Mexico's Department of Health has published a 21-page overview document providing guidance on COVID-19, Policies for the Prevention and Control of COVID-19 in New Mexico. It is intended as a resource for members of the public, health care providers, and employers who may have general questions about COVID-19 and the recommended guidance in responding to and protecting against the virus.
  • Oregon Gov. Kate Brown (D) announced that two counties—Hood River and Multnomah—have succeeded in reducing the spread of COVID-19 sufficiently enough to be removed from the County Watch List. No counties have been added this week. This brings the total number of counties on the Watch List to six.
  • Rhode Island Gov. Gina Raimondo (D) signed an EO extending the Phase 3 pandemic restrictions another 30 days, until September 28. It includes a 15-person limit on social gatherings, though indoor gatherings can have 50 people and outdoor gatherings 100 if they are held at a restaurant or are catered and follow the rules for restaurants to keep parties apart and having patrons wear masks when not seated.
  • New York Gov. Andrew Cuomo (D) deployed a SWAT team to SUNY Oneonta to contain a COVID-19 cluster that has developed there. The State team will include 71 contact tracers and eight case investigators. New York State will also open three free, rapid testing sites in the city of Oneonta. The sites will be open to all city residents by appointment, and results come back in 15 minutes. 
  • Mississippi Gov. Tate Reeves (R) extended the statewide mask mandate for an additional two weeks until September 14. 
  • Starting Friday, New Jersey movie theaters and other indoor performance venues can reopen with limits for the first time since the middle of March, and restaurants can open for indoor dining at 25 percent of capacity.
  • 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
  • Spain has recorded more than 53,000 new cases in the last week. 
  • Students in Hong Kong will start school in person on September 23.
  • Greece issued a new directive temporarily suspending all passenger flights to the Catalonia region in Spain.
  • India now has the world’s third-highest COVID-19 death toll behind the U.S. and Brazil at 64,469 total deaths.
    • India's National Statistical Office said the country's economy contracted by nearly 24 percent in the first quarter of the 2020-2021 fiscal year, which ended in June, compared with the same quarter the previous year.
  • Canadian Prime Minister Justin Trudeau said yesterday that his government has arranged to buy 76 million doses of a vaccine now under development by Novavax, and 38 million doses of a different proposed vaccine from Johnson & Johnson. Canada had already said they planned to buy 20 million doses of a Pfizer vaccine and 56 million doses of a Moderna vaccine
  • In New Zealand, officials reported nine new cases yesterday, including four imported cases and five community cases linked to a cluster in Auckland. Yesterday was also the first day when it is mandatory to wear masks on public transportation nationwide in New Zealand. 
  • Australia reported its highest daily death toll yesterday, most of which were from the past month that had not been recorded earlier. Of the 41 deaths, eight were in the previous 24 hours. The rest were in nursing homes as early as late July, and are only just being counted because of a change in the way they are required to report COVID-19 deaths.
  • Global Cases: 25,506,759      Total Deaths: 851,059
Lifestyle, Science, and Economy
  • According to a new study in CDC's MMWR, a large number of doctors, nurses, and other health care workers may be going undiagnosed after they become infected despite being at high risk for developing COVID-19. The report found that around 6 percent of the workers had antibody evidence of a previous coronavirus infection, and more than two-thirds of these individuals had not been previously diagnosed.
  • The directors of the Intellectual and Developmental Disabilities Research Centers (IDDRC) Network, a nationwide group funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, have said the COVID-19 pandemic has taken a disproportionate toll on people with intellectual and developmental disabilities (IDDs). Read more here
  • Data compiled by the American Academy of Pediatrics from the summer show that cases, hospitalizations, and deaths from COVID-19 have increased at a faster rate in children and teenagers than among the general public.
  • Airborne transmission of SARS-CoV-2 remains one of the most critical questions to solve in terms of getting the COVID-19 pandemic under control. Watch the National Academies' webinar "Airborne Transmission of SARS-CoV-2," in which experts reviewed the available data along with some historical context.
  • Nearly half of the top 20 metropolitan areas where new cases per capita rose the most over the past two weeks are college towns.
  • The University of Missouri yesterday reported an additional 109 cases of COVID-19, bringing the school’s total to 415. This seems like a lot, until you consider the University of Alabama's more than 1,200 infected students. 
  • Zoom reported higher sales and profit in the three months from May through July than it did in all of 2019, as more people work from home and have begun online schooling/distance learning.
  • United, Delta, and American Airlines all announced they will be dropping domestic change fees in light of uncertainty caused by the pandemic. 
  • 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
  • BIO’s COVID-19 pipeline for vaccines, antivirals and treatments 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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