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COVID-19 Update
September 4, 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, 67,844 Iowans have tested positive, up 1,312 from our update yesterday morning, with a total of 654,603 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 1,137 deaths. Now 48,508 Iowans have recovered. The overall positivity rate is 10.4% and the total 14 day rolling average positivity rate is 11.1%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.
 
The state has been changing how it reports testing data, which has caused spikes in the rate of positive data. Before the changes, the state was consistently reporting a positivity rate, below 10%.
 
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 12 counties are above 15 percent positivity rate over the past 14 days:
Johnson 24.9%
Story 22.6%
Sioux 22.2%
Plymouth 21.8%
Caroll 18.8%
Howard 18.6%
Bremmer 17.7%
Lyon 17.1%
Crawford 16.2%
Lee 15.8%
Marion 15.8%
Delaware 15%
 
Federal Legislation
Supplemental IV
Timeline: There’s been very little change this week, as negotiations remain stalled. After another fruitless phone call on Tuesday, this time between Speaker Pelosi and Secretary Mnuchin, Speaker Pelosi put out a statement. In the statement, she implied the White House is not taking the pandemic and its impacts on working families seriously and has defied science and experts’ recommendations. Speaker Pelosi has made it clear that she believes Democrats have already offered a significant compromise by coming down from the $3.5 trillion Heroes Act to $2.2 trillion. Pelosi has continued to assert that she believes that until the White House offers a compromise number, no negotiations will be useful.
 
The Senate returns to town next week and the House comes back the following week. The physical presence of members may stir up additional momentum. Pressure will only increase in the coming weeks as the end of the fiscal year on September 30 looms. It seems that leaders will need to either 1) negotiations restart when the Senate returns 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) negotiations do not restart and it is more of the same positioning -- in this case, Congress could either allow a shutdown or may fall back on short-term clean extensions of government funding to buy more time.
 
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.
 
Process/Politics: The readout from the Monday Democratic caucus call indicated that rank and file Democrats remain united behind Speaker Pelosi’s strategy of holding firm. A handful of frontline members and those in the Problem Solvers Caucus continue to say various things for press purposes, but behind the scenes remain dedicated to Pelosi’s strategy. Yesterday, Leader Schumer sent out a Dear Colleague that outlined the Democratic position and again asserted the Republicans have “refused to make any significant compromise”.
 
Senate Republicans, however, have been putting pressure on leadership to do something. There have been a series of rumors that McConnell is putting together a skinnier bill, under $1 trillion, possibly as low as $500 million, in an attempt to find something to unify the conference. If McConnell can pull together something that Senate Republicans can agree upon, it could be a positive catalyst for negotiations and push McConnell back in the negotiating room. However, all indications are showing that there isn’t something Republicans can rally around – some seem to be focusing on how their positions and votes taken now could affect them in the future (i.e. 2024).
 
Another dynamic at play, which both the Biden and Trump campaigns are aware of, is the possibility of the next package including another round of stimulus checks, which, depending on timeline, could wind up at voters’ doorsteps in October, right before the election.
 
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. Notably, Democrats in the House passed the Heroes Act mid-May and Senate Republicans have yet to significantly unify around a bill. When HEALs was introduced, Senate leadership indicated that almost half the Senate Republican Conference would not vote for it.  
 
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
  • 9/1 – The minority staff of the Select Subcommittee on the Coronavirus Crisis released a report on the Paycheck Protection Program. Report here.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (2): Rep. Jenniffer Gonzalez-Colon (R-Puerto Rico at large), Rep. Dan Meuser (R-PA)
Currently Self-Quarantined (0): 
Recovered (13): 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)
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
  • HHS, through HRSA, announced the details of a $2 billion Provider Relief Fund performance-based incentive payment distribution to nursing homes. This distribution is the latest update in the previously announced $5 billion in planned support to nursing homes grappling with the impact of COVID-19. Last week, HHS announced it had delivered an additional $2.5 billion in payments to nursing homes to help with upfront COVID-19-related expenses for testing, staffing, and PPE needs. Other resources are also being dedicated to support training, mentorship, and safety improvements in nursing homes.
  • The FCC, HHS, and USDA announced that they have signed a Memorandum of Understanding to work together on the Rural Telehealth Initiative, a joint effort to collaborate and share information to address health disparities, resolve service provider challenges, and promote broadband services and technology to rural areas in America. This action comes as the coronavirus pandemic has highlighted the critical importance of telehealth in delivering quality healthcare to rural Americans. According to FCC Chairman Ajit Pai, recent telehealth efforts have, "allowed for more patients to be treated at home, freeing up valuable hospital beds for those who most need them, and reducing the risk of exposure to the virus."
  • Earlier this week, the FDA updated its guidance, “Investigational COVID-19 Convalescent Plasma,” to provide additional information related to the recently issued EUA for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. This update includes a discussion regarding FDA’s intent to exercise temporary enforcement discretion regarding the IND requirements for the use of this product when blood establishments, hospitals, and health care providers collect plasma that does not meet the Conditions of Authorization of the EUA. The revised guidance continues to provide recommendations for health care providers who wish to administer and study convalescent plasma under an Investigational New Drug Application. In addition, the agency updated the web page, “Recommendations for Investigational COVID-19 Convalescent Plasma,” which also provides this information.
  • The FDA’s COVID-19-related consumer updates are now available in at least five languages.
  • 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 CDC has asked states to prepare to distribute a potential COVID-19 vaccine as soon as late October, according to a series of planning documents sent to public health officials last week. CDC Director Robert Redfield also sent a letter to governors asking them to fast-track permits and licenses so that vaccine distribution sites can be up and running by November 1 in their states. 
  • CDC Director Robert Redfield signed a declaration issuing a temporary halt in residential evictions and stated that the evictions of tenants could be detrimental to public health control measures to slow the spread of COVID-19.
  • The CDC continues to update online resources and guidance documents. Here are a few of the most recent updates:
  • The NIH has launched a study to track the prevalence and impact of SARS-CoV-2 infection among approximately 16,000 pregnant women in seven low- and middle-income countries. The study will follow women through pregnancy and 12 months after childbirth to compare maternal, fetal and newborn outcomes of participants who have been infected with the virus to those of pregnant women who have not been infected.
  • NIH announced $129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. These tests add to initial awards made to seven companies on July 31.
  • The Office of the Inspector General (OIG) recently posted FAQs pertaining to the application of the OIG's administrative enforcement authorities connected to the COVID-19 public health emergency.  
  • HHS said in a statement that they are canceling some remaining orders for ventilators as the SNS is full with nearly 120,000 ventilators available. 
  • HHS/HRSA announced assisted living facilities (ALFs) may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation, funding that was made possible through the bipartisan CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. Like other providers applying for Phase 2 funding, eligible ALFs will receive 2 percent of their annual revenue from patient care.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 6,087,403 total cases and 185,092 deaths The CDC data closes out the day before reporting.
  • Michigan Gov. Gretchen Whitmer (D) signed an EO opening gyms, fitness centers, pools, and other sports facilities. The order also allows organized sports to resume, although the state recommends against contact sports like football, soccer, and basketball.
  • New York Gov. Andrew Cuomo (D) said malls in New York City and casinos across the state will be allowed to reopen on September 9 at 50 percent capacity. Both will have to have specialized air conditioning systems capable of filtering out virus particles.
  • Des Moines Mayor Frank Cownie issued a mask mandate for his city last week.
  • North Carolina Gov. Roy Cooper (D) announced that the state will take a "modest" step forward and move into Phase 2.5 starting this Friday at 5 pm. Mask mandates and other prevention methods will remain in effect.
  • New Jersey Gov. Phil Murphy (D) signed an EO increasing the limits for indoor religious services or celebrations, political activities, wedding ceremonies, funerals, or memorial services to 25 percent capacity with a maximum of 150 people. Other indoor gatherings, including house parties, remain at the limit of 25 percent capacity with a maximum of 25 people.
  • Nevada’s coronavirus task force voted to allow some restaurants in the Las Vegas area to reopen next week.
  • Missouri Gov. Mike Parson (R) said that, in the month of August alone, nearly 7,000 people in Missouri in the 18-24 age group tested positive for COVID-19.
  • Connecticut Gov. Ned Lamont (D) announced that the state has formed a rapid response team to do testing in schools and childcare facilities in case of potential COVID-19 infections or outbreaks.
  • 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
  • An Amnesty International report states that more than 7,000 health care workers have died from COVID-19 globally. Mexico has lost the most, with 1,320 health worker deaths. The U.S. is close behind with 1,077. Britain, Brazil, Russia, and India each have lost about 600 workers.
  • Thailand has gone 100 days without a reported case of local transmission, but its success has come at a steep financial cost. The country’s last reported case of community transmission was confirmed on May 24. Hundreds of cases have been found since then among residents returning from abroad, but all have been detected during the required 14-day quarantine periods. 
  • India reported 83,883 new cases on Thursday, breaking its own global record.
  • The Czech Republic reported its highest single-day increase today with 650 new cases.
  • Turkish officials said they will be placing restrictions on weddings and other social events amid a surge in new cases. The daily number of cases has reached almost 1,600 in the last week.
  • Jamaica plans to go ahead with in-person elections. On election day, all voters will be required to wear face masks and maintain social distancing at polling stations. Moreover, the government has hired 7,000 workers to help maintain other hygienic measures such as sanitizing pencils each time they’re used to fill out a ballot. While Jamaican voters traditionally dip a finger in ink to signal that they’ve cast a ballot, they'll instead be using germ-killing alcohol-based ink.
  • The WHO said yesterday that the global effort to develop and equitably distribute a coronavirus vaccine will reserve 220 million doses for the African continent to ensure it is not left behind. The doses are expected to cover 20 percent of individuals on the continent and would be distributed to each country based on population size. Front-line health-care workers, the elderly, and those with preexisting conditions will likely have priority (in that order).
  • British Health Secretary Matt Hancock says the country’s COVID-19 testing system is working “well” despite British media reports that people are having to travel up to 100 miles to visit a test center because of shortages or lack of local access.
  • Brazil surpassed 4 million cases of COVID-19 yesterday.
  • Former prime minister of Italy Silvio Berlusconi has tested positive for COVID-19 after a “precautionary check."
  • Global Cases: 26,333,573      Total Deaths: 869,306
Lifestyle, Science, and Economy
  • Earlier this week, the National Academies of Sciences, Engineering, and Medicine released for public comment a discussion draft of a preliminary framework to assist policymakers in planning for equitable allocation of a vaccine against COVID-19. The discussion draft includes a summary of lessons learned from past allocation frameworks for mass vaccination campaigns, including for H1N1 influenza in 2009 and during the Ebola epidemic in West Africa in 2013-2016, as well as from recent guidance during the COVID-19 pandemic for the allocation of scarce resources, such as medical resources and supplies. 
  • Recent data shows that more than three-quarters of people interviewed in states with high infection rates, like California and Louisiana, refused to cooperate with contact tracing efforts to identify relatives or acquaintances who may have been exposed to COVID-19. 
  • International clinical trials published on Wednesday confirmed hope that cheap, widely available steroid drugs can help seriously ill patients survive COVID-19. The new studies include an analysis that pooled data from seven randomized clinical trials evaluating three steroids in more than 1,700 patients. The study concluded that each of the three drugs reduced the risk of death. The WHO has updated their treatment guidance accordingly. 
  • New CDC cellphone data indicates stay-at-home orders issued across the U.S. in the spring really did work at keeping people home.
  • Results from a recent New York Times survey of more than 1,500 schools showed that over two-thirds of the schools have reported at least one case of COVID-19. More than 100 of the institutions have reported at least 100 cases. Auburn, Illinois State, and South Carolina are among at least six universities with more than 1,000 known cases.
    • Indiana University encouraged fraternity and sorority houses at the Bloomington campus to close after at least five Greek houses reported positivity rates of more than 50 percent.
    • NIH's Dr. Tony Fauci is strongly discouraging schools from sending students home, where they could spread the virus within their home states when they return.
  • The pandemic has caused people to lose sleep over heightened stress and disrupted routines. Experts are referring to it as “Coronasomnia,” as and they say it could prove to have profound public-health ramifications, such as creating a new population of chronic insomniacs dealing with decreased productivity, amplified tempers, and increased risks of hypertension, depression, and other health problems.
  • An additional 881,000 people applied for state unemployment benefits last week.
  • Researchers from the Massachusetts Institute of Technology at Brigham and Women’s Hospital, have created a dog-like robot called Dr. Spot that uses a tablet mounted for doctors to communicate with patients remotely over a video call.  Developed by Boston Dynamics, the robot dogs are controlled by a handheld device. Researchers say the technology includes four infrared and light wavelength-measuring cameras to monitor body temperature, breathing rate, blood oxygen saturation, and pulse. The project researchers have successfully tested the technology on healthy patients from a distance of up to three meters, so they now plan to try it on patients with COVID-19 symptoms to see if it's possible to minimize in-person contact with patients.
  • Pfizer’s chief executive, Dr. Albert Bourla, said yesterday that the company expects to know whether its vaccine is effective by the end of next month, and that it would apply immediately for approval if that turns out to be the case.
  • United Airlines announced that they will have to put 16,370 workers on involuntary, indefinite furlough at the start of October unless they receive additional federal aid. 
  • Toshiro Muto, CEO of the Tokyo 2020 Olympics, said he thinks the postponed games could proceed without a vaccine, but that there would just be a limited number of spectators. 
  • Filming for the new movie "The Batman" has been put on hold after lead actor, Robert Pattinson, tested positive for COVID-19. 
  • 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 BIO COVID-19 Pipeline tracker, 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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