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COVID-19 Update
August 14, 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, 50,681 Iowans have tested positive, up 678 from our update yesterday morning, with a total of 540,974 tested.  10 additional deaths were reported since our last update, bringing the total to 964 deaths. Now 39,788 Iowans have recovered. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here. The per county percentage positivity rates and school district statistics can be found here.

Federal Legislation
Supplemental IV
Timeline: Things aren’t looking good. There’s an expectation that no negotiations, barring an unforeseen shakeup, will resume until after both parties’ nominating conventions. Secretary Mnuchin reached out to Speaker Pelosi earlier this week, but because neither side had shifted, the calculus remained the same and nothing came of it. White House Chief of Staff Meadows is apparently on vacation currently. Negotiations will likely resume in September.
 
Process/Politics: Before negotiations broke down, Speaker Pelosi and Leader Schumer offered White House Chief of Staff Meadows and Secretary Mnuchin to set the top line at $2 trillion – Democrats would come down $1 trillion and Republicans would come up $1 trillion. Republicans rejected that offer and countered with negotiating and passing multiple, smaller bills, which Speaker Pelosi and Leader Schumer declined. Speaker Pelosi has continued to reiterate that negotiations will not resume until there is agreement on the top line number. The White House believes the numbers on new unemployment claims and the stock market’s resilience has bolstered their choice to hold on going above $1 trillion.
 
There’s been very little, if any, pushback on Speaker Pelosi from her caucus – Democrats remain united behind the strategy to continue to hold for a better deal. However, members have been increasingly concerned about funding and management of the US Postal Service considering the election.
 
As mentioned in previous updates, even if discussions were to start again soon, it will take negotiators a while to agree upon a framework and allow committees to hammer out details. Committees will likely not be able to work through every issue and would need to pass most contentious issues back up to leadership. Once negotiations resume, a deal and a final bill will take time to draft and hammer out.
 
Note: As it increasingly looks like negotiations will bleed into September and funding for the government runs out September 30, Congress will need to pass a very clean continuing resolution (CR). A clean CR still requires negotiations – there are always riders, small changes, and other additions. However, there is a hope that members will recognize the necessity of reserving political will for negotiations on the COVID 4 package and limit the number of add-ons on the CR.
 
Policy: As the executive orders the President issued last Saturday partially indicated, the next package will likely address unemployment insurance, funding for testing and providers, funding for education, and likely some form of rental and student assistance. The most contentious issues, however, continue to be unemployment insurance and the level of funding for state, local, and tribal governments. Democrats have also pushed for funding for broadband, the U.S. Postal Service, and election security, among other things.
 
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 here. Continuing Small Business Recovery and Paycheck Protection Program Act (Small Business provisions) press release here, text here, section by section here, one pager here. Coronavirus Response Additional Supplemental Appropriations Act (Appropriations provisions) text here, summary here. Restoring Critical Supply Chains and Intellectual Property Act (Supply Chain and Research provisions) text here, section by section here. SAFE TO WORK Act (Liability Relief) text here, section by section here. Safely Back to School and Back to Work Act (Health, Education, and Labor Provisions) text here, section by section here. Supporting 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
  • 8/10 – The Treasury Department and Small Business Administration released updated data on the Paycheck Protection Program. Data here.
  • 8/9 – The Department of Labor notified governors of their ability to apply for funding for unemployment insurance, made available through the President’s executive order last Saturday. Link to funding application here. Notice of announcement here.
  • 8/7 – HHS and the Health Resources and Services Administration announced the next distribution for nursing homes through the Provider Relief Fund. The distribution will total $5 billion and will be used by nursing homes to protect residents. Approximately $2.5 billion in funding will be dedicated to increasing testing, staffing, and PPE needs of nursing homes and long-term care facilities. The initial $2.5 billion will go out mid-August, with the remaining distributed through the fall. Press release here.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (2): Rep. Raúl Grijalva (D-AZ), Rep. Rodney Davis (R-IL)
Currently Self-Quarantined (1): Rep. Guy Reschenthaler (R-PA)
Recovered (10): 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)
Completed Quarantine (44): 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)
 
*Mark Meadows was quarantined as a member of Congress, before he resigned to become the White House Chief of Staff.

Washington, D.C.
  • Yesterday, HHS announced combined investments of $6.5 million in two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional COVID-19 tests per month. The investments in Aegis Sciences Corporation and Sonic Healthcare USA will provide critical laboratory equipment supplied by Beckman Coulter Life Sciences and Thermo Fisher Scientific and increase staffing and infrastructure to allow the U.S. to perform an additional 1 million tests each week by early October.
  • On Tuesday, HHS Sec. Alex Azar met with former Taiwan Vice President Chen and a group of COVID-19 response experts for a discussion on Taiwan's pandemic response and ways the U.S. and Taiwan can further their collaboration on disease response and other global health issues.
  • HHS and the DoD yesterday announced an agreement with Moderna, Inc. to manufacture and deliver 100 million doses of the company’s COVID-19 vaccine candidate. The federal government will own these vaccine doses. Moderna will manufacture the vaccine doses while clinical trials are underway. Manufacturing in parallel with clinical trials expedites the traditional vaccine development timeline and builds toward the U.S. government’s Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year. If the FDA authorizes use, the vaccine doses would be distributed and used as part of a COVID-19 vaccination campaign.
  • Tuesday, HHS issued a Notice of Funding Opportunity to expand and accelerate innovative uses of electronic health information via health information exchanges (HIEs) to support state and local public health agencies. The Agency says that strengthening health data exchange and use between HIEs and state and local public health agencies will help communities to better prevent, respond to, and recover from public health emergencies, including disasters and pandemics such as COVID-19. Award recipients will focus on improving HIE services (such as last-mile connectivity and data services) in support of state and local public health agencies. Award recipients will be required to deploy services that can enable, enhance, or increase the use of health information exchange at the state and local levels among relevant entities, and be inclusive of a diverse set of participating providers, including those who care for vulnerable or at-risk populations. They also will be required to engage in activities that address communities disproportionately impacted by the COVID-19 pandemic, considering factors such as age, race, ethnicity, disability, and sex. 
  • Read Assistant Sec. for Health ADM Brett Giroir's statement on COVID-19 point-of-care testing efforts in Miami here.
  • The Administration for Community Living (ACL) announced that the ARCH National Respite Network's Lifespan Respite Technical Assistance Center, working with experts in the field of respite services, has released Voluntary National Guidelines on Providing and Receiving Respite Safely during the Pandemic.
  • The FDA posted a new website with FAQs on Importing Medical Devices During the COVID-19 Pandemic. The FAQ page provides information on importing devices that have been issued EUAs and devices for which an enforcement-discretion policy has been published in a guidance document. The page also includes content on importing respirators, face masks, and PPE, donating medical devices, importing other medical devices, monitoring import status, and identifying contacts for import questions.
  • The FDA also posted a new webpage with FAQs on Registration and Listing of Medical Devices During the COVID-19 Pandemic. This page provides information for medical device establishments, including owners and operators of places of business (also called facilities) that are involved in the production (e.g., manufacturing, assembling, processing) and distribution of medical devices that are authorized by EUAs or that are the subject of one of FDA’s COVID-19 guidance documents.
  • Wednesday, the FDA published an online Consumer Update with tips on how individuals can take some simple steps to help slow the spread of COVID-19. 
  • The CDC has published new PSAs to encourage individuals who have recovered from COVID-19 to donate plasma
  • The CDC continues to update its dashboard with new guidance documents and details, and the newest toolkits. A few of the most recent additions include:
  • The CDC updated its website to warn against using masks with exhalation valves or vents to slow the spread of COVID-19. According to the updated page, masks with vents or valves, “allow air to be exhaled through a hole in the material, which can result in expelled respiratory droplets that can reach others...This type of mask does not prevent the person wearing the mask from transmitting COVID-19 to others.”
  • Wednesday, Rep. Jim Clyburn (D-SC), Chairman of the Select Subcommittee on the Coronavirus Crisis, sent letters to HHS Sec. Alex Azar, Operation Warp Speed Chief Advisor Dr. Moncef Slaoui, and President and Chief Executive Officer of Advanced Decision Vectors David Harris, seeking documents and information on potential conflicts of interest in Operation Warp Speed, the Administration’s vaccine and therapeutic development initiative.  The letters also seek information on the Administration’s process to select vaccine candidates for investment through this initiative. Click here to read the letters to Sec. AzarDr. Moncef Slaoui, and David Harris.
  • Earlier this week, House Energy and Commerce Committee Chairman Frank Pallone (D-NJ), Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) wrote to CDC Director Robert Redfield requesting a briefing on the concerning impacts of COVID-19 on the nation’s children and young people.
  • A readout from Vice President Pence's Governors Briefing on COVID-19 response & best practices is available here
  • President Trump is considering new immigration regulations that would allow border officials to temporarily block American citizens and legal permanent residents from returning to the U.S. from abroad if authorities believe they have COVID-19.
  • President Trump said the federal government is sending 125 million reusable face masks to school districts across the U.S. as schools consider whether it’s safe to reopen this fall amid the pandemic.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 5,176,018 total cases and 165,148 deaths The CDC data closes out the day before reporting. 
  • California has become the first state to surpass 600,000 cases of COVID-19. Gov. Gavin Newsom (D) said Wednesday that the state was “turning the corner on this pandemic” after hospitalizations declined 19 percent in two weeks. 
  • Hawaii, one of two states that has seen sustained increases in cases in recent days, announced more than 350 new cases, its single-day record. Illinois is the other state with sustained increases. 
    • On Tuesday, Florida and Georgia both reported their highest single-day COVID-19 death tolls.
  • North Dakota also broke its record for cases in a single day, with 201.
  • New Jersey Gov. Phil Murphy (D) signed an EO that allows schools and universities to reopen for the upcoming academic year. School districts in the state still have the option to offer all-virtual classes.
  • Texas Gov. Greg Abbott (R) said the state is ramping up distribution of PPE and encouraging Texans to wear masks and socially distance as cases in the state passed 500,000.
  • Atlanta Mayor Keisha Lance Bottoms (D) ordered a series of actions to address racial disparities due to the COVID-19 pandemic in her city, including reports, advisory councils, town halls, and mask campaigns.
  • Colorado Gov. Jared Polis (D) extended the state's mandatory mask order.
  • The St. Louis, Missouri, Health Department issued an order that limits capacity of bars, restaurants, and nightclubs to 50 percent occupancy and institutes an 11:00 PM closing time.
  • Kansas City Mayor Quinton Lucas extended the city's COVID-19 state of emergency to January 16, 2021.
  • Schools in Georgia, Louisiana, Texas, and Mississippi have all reported cases of COVID-19 among staff and/or students after returning to in-person classes. 
  • Several school districts in Arizona — which has one of the highest rates of COVID-19 in the country — plan to begin in-person schooling on Monday despite not meeting the suggested health benchmarks.
  • 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
  • New Zealand reported 13 new community cases of COVID-19 as the country tackles a fresh outbreak that ended a run of more than 100 days without any locally transmitted infections. Prime Minister Jacinda Ardern said it was a positive sign that all 13 new community cases were linked back to one infected family, either via work or broader family connections, and that all were being transferred into quarantine facilities. 
  • On Tuesday, Russian President Vladimir Putin announced the approval of a COVID-19 vaccine for use.
    • Dr. Bruce Aylward, senior adviser of the director-general of the WHO, said there is not “sufficient information at this point to make a judgement” on the Russian vaccine. U.S. health officials have also questioned the safety and efficacy of the vaccine. 
  • Brazil reported 55,155 new COVID-19 cases as well as an additional 1,175 deaths in the past 24 hours. 
  • Peru’s President Martin Vizcarra announced new lockdown measures after the country has reported increases in COVID-19 cases during the month of July. Vizcarra issued an official decree that orders six more regions and 34 provinces placed under localized lockdown.
  • Australia posted its lowest one-day rise in new COVID-19 cases in more than three weeks yesterday, dampening hopes that a second wave of new infections in Victoria state is being brought under control. Australian states and territories most recently reported 292 new infections in the past 24 hours, down from 428 detected in the previous day and the lowest since July 20. 
  • The Philippines plans to start clinical trials for a Russian COVID-19 vaccine in October, with President Rodrigo Duterte expected to be inoculated as early as May 2021.
  • A sample of frozen chicken wings imported into the southern Chinese city of Shenzhen from Brazil has tested positive for the coronavirus, according to a notice from the city government.
  • India has now reported the fourth most coronavirus-related deaths in the world after the U.S., Brazil, and Mexico. It surpassed Britain in yesterday's reports. 
  • The British economy has reportedly plunged into a record-shattering recession, shrinking by a fifth in the second quarter and posting the steepest decline of any Group of Seven nation.
  • One of Greece’s overcrowded camps for migrants has recorded its first few COVID-19 cases, prompting officials to lock down the camp until August 25.
  • Mexico and Argentina announced a deal to produce an initial batch of 150 million to 250 million doses of the AstraZenica vaccine against the coronavirus and distribute them in Latin America, with manufacturing potentially starting in early 2021.
  • Students and staff have tested positive for COVID-19 at eight schools in Berlin, just days after many students returned to classrooms.
  • Global Cases: 20,950,402    Total Deaths:  760,213
Lifestyle, Science, and Economy
  • In a recent survey, U.S. residents reported signs of eroding mental health, in reaction to the toll of COVID-19 illnesses and deaths and to the life-altering restrictions imposed by lockdowns. Young adults and Black and Latino people in particular describe rising levels of anxiety, depression and even suicidal thoughts, and increased substance abuse, according to findings from the CDC.
  • A study in CDC's Morbidity and Mortality Weekly Report suggests that pregnant women with COVID-19 are more likely to be hospitalized and are at increased risk for intensive care unit (ICU) admission and receipt of mechanical ventilation than nonpregnant women. Risk of death is similar for both groups. But much remains unknown. Read more here
  • Federal data cited by two long-term care associations this week show that the number of new cases in nursing homes bottomed out at 5,468 during the week of June 21 and has climbed steadily upward to 8,628 for the week of July 19, the latest available week. That is a 58 percent increase that roughly parallels the rise in U.S. cases overall during that time.
  • A recent article in the New England Journal of Medicine points out that minority groups are underrepresented in clinical trials and calls on government agencies, medical journals, and research funders, among others, to diversify study participants in order to be able to generalize results to the larger U.S. population.
  • Data collected by Stanford researchers in May shows that teenagers and young adults who vape face a much higher risk of COVID-19 than their peers who do not vape.
  • New research and state-by-state data from Brown University suggests that stay-at-home orders helped slow the pandemic significantly.
  • Chinese company CanSino Biologics Inc. has begun conducting Phase 3 trials of its COVID-19 vaccine in Saudi Arabia, after completing the first two phases of the human trials in China. Following confirmation of the vaccine’s effectiveness and safety of the vaccine in Phase 1 and 2, Phase 3 will involve multi-center clinical studies in several countries and a large number of volunteers.
  • Public release of hospital data about COVID-19 has slowed to a crawl, one month after the federal government ordered states to report it directly to HHS and bypass the CDC. One report cites that key indicators, such as estimates of the portion of inpatient beds occupied by COVID-19 patients, are lagging by a week or more, making it harder for citizens and local officials to get a handle on how the pandemic is progressing and for agencies to allocate supplies of antiviral drugs and PPE.
  • Pennsylvania State University is making students sign a liability agreement and assume all risk of COVID-19 prior to returning to campus for the fall semester.
  • Unemployment claims fell below 1 million in the U.S. for the first time in four months. 
  • AMC Theaters, the country’s largest movie theater chain, announced it will resume operations August 20 after a five-month shutdown, selling tickets for 15 cents.
  • NCAA President Mark Emmert announced today that Division I fall sports championships excluding football would be canceled. Please send book recommendations my way as NCAA Women's Soccer previously consumed my autumn free time. 
  • The BIO COVID-19 pipeline tracker for vaccines, antivirals and treatments is here.
  • 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
  • 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 Biotechnology Association, All rights reserved.


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