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COVID-19 Update
March 31, 2020

IowaBio wants to provide our members useful information during the COVID-19 public health emergency. 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.

Iowa Update

Governor Kim Reynolds will hold a press conference today at 2:30 p.m. The press conference will be livestreamed and posted in full on Governor Reynolds’ Facebook Page, YouTube, and Iowa PBS.
 
The Iowa Department of Public Health (IDPH) has been notified of 73 additional positive cases of Iowans with COVID-19, for a total of 497 positive cases. One death was reported in Muscatine County, a middle-aged (41-60) resident. There have been a total of 6,888 negative tests to date, which includes testing reported by the State Hygienic Lab and other labs. 
 
According to IDPH, the locations and age ranges of the 73 individuals include:
  • Black Hawk County, 1 middle-age adult (41-60 years)
  • Cedar County, 1 middle age adult (41-60 years)
  • Clay County, 1 adult (18-40 years)
  • Clinton County, 2 middle-age adults (41-60 years), 1 older adult (61-80 years)
  • Dallas County, 4 adults (18-40 years)
  • Harrison County, 1 middle age adult (41-60 years)
  • Iowa County, 1 middle-age adult (41-60 years)
  • Jasper County, 1 elderly adult (81+)
  • Johnson County, 2 adults (18-40 years), 1 middle-age (41-60 years)
  • Jones County, 2 adults (18-40 years), 1 middle age (41-60 years)
  • Keokuk County, 1 adult (18-40 years)
  • Linn County, 3 adults (18-40 years), 7 middle age adults (41-60 years), 7 older adults (61-80 years), 2 elderly (81+)
  • Marshall County, 1 adult (18-40 years), 1 older adult (61-80 years)
  • Muscatine County, 2 middle-age (41-60 years), 1 older adult (61-80 years)
  • Polk County, 1 child (0-17), 5 adults (18-40 years), 3 middle age adults (41-60 years), 4 older adult (61-80 years), 2 elderly (81+)
  • Pottawattamie County, 1 middle-age (41-60 years)
  • Scott County, 2 middle-age (41-60 years)
  • Sioux County, 1 middle age adult (41-60 years), 1 older adult (61-80 years)
  • Tama County, 1 adult (18-40 years)
  • Warren County, 2 middle-age (41-60 years)
  • Washington County, 3 adults (18-40 years), 2 older adults (61-80 years), 1 elderly (81+)
A status report of monitoring and testing of COVID19 in Iowa is provided by IDPH and can be found here. In addition, a public hotline has been established for Iowans with questions about COVID-19. The line is available 24/7 by calling 2-1-1 or 1-800-244-7431. The state of Iowa has started sharing the number of negative tests conducted at outside labs, and is providing additional information on the conditions of those infected with COVID-19. 
 
Yesterday at her press conference, Governor Reynolds spoke about companies across the state have stepped up to manufacture PPE including masks, gowns and facemasks. Other companies including Kemin, Corteva, and ADM, and Universities have donated PPE. The Governor said more Iowans are now being tested as testing capabilities ramp up. She touted the new Abbot tests that come back in 5 minutes for positive tests, and can be done at the point of care. She said the company will be making 50,000 tests each day over the next 30 days. Although most tests will go to the epicenter to places like New York, each state will get 15 machines for testing. (For more on Abbott’s test click here.) She spoke about prioritizing testing for healthcare workers and then additional testing as needed. Governor Reynolds said she continues to evaluate metrics from a local and regional perspective, to make decisions based on that for social and business restrictions. She is concerned about the supply chain and workforce for healthcare. IDPH is looking at data and new modeling to help show possible peak of the disease, which likely is within the next two weeks.  As restrictions are lifted, they will watch again for another peak in fall.

IowaBio Member Company Highlights
  • IowaBio member Kemin, donated 10,000 pieces of PPE to the Iowa Department of Public Health to help alleviate the shortage of personal protective equipment for frontline healthcare workers.
     
  • Yesterday Johnson & Johnson announced it will partner with a government agency and has committed a major investment of its resources to develop and manufacture a vaccine for COVID-19. Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.

    Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the Company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

    As part of its commitment, Johnson & Johnson is also expanding the Company’s global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally. The Company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. See this article for more. In addition, Johnson & Johnson announced a $50 million commitment to support frontline health workers battling COVID-19.
     
  • HHS accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. According to HHS, these and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market. Despite relatively scant evidence that the drug actually has an effect on COVID-19 patients, hospitals are already using the drugs on severely ill patients. The mentioned drugs are the same ones used to treat malaria, as well as a slew of other illnesses whose patients are now facing a shortage of drugs on which they rely.

    The FDA had already issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.
Federal Legislation

As the pace of federal action has slowed, this section of the newsletter will change in frequency in content.

Supplemental IV and onward

Timeline: House and Senate leadership have been in contact about the timeline for the next package. Speaker Pelosi has voiced that she aims to have her package ready for when the Senate and House return at the end of April. Republicans have pushed back on the quick timeline and do not see the next package moving as quickly as the last couple. This week, most staff and committees are taking a breather from drafting bills and are focusing on COVID III implementation. Many are sending bipartisan letters clarifying the intent of COVID III, often at the request of agencies.

Policy: It’s likely that the next COVID-19 bill focuses on infrastructure as an economic stimulus and includes provisions aimed at recovering from the current crisis. Which committees will play the lead role will depend on what issues remain (or develop) over the next few weeks, but it is likely that the committees focused on health (House E&C, Senate HELP), transportation/infrastructure (House T&I, Senate Commerce, Senate EPW), and finance (House W&Ms, Senate Finance) will be significantly involved in drafting the next bill.

Passed Legislation

Supplemental III – Coronavirus Aid, Relief, and Economic Security (CARES) Act

After a unanimous vote by the Senate, the House passed the bill on March 27 and the President signed the bill into law shortly after. Final text here. Democratic summary here. Republican section by section here.

Implementation: The Treasury Department expects the guidelines and regulations related to the small business provisions within the bill will be released within the next day or so. The certified SBA lenders will likely be able to begin processing loans later this week.

See below for resources on certain areas of the bill:
  • Memo for health care providers here
  • Memo on the Small Business Administration loan programs here
  • Memo outlining the workers and families assistance programs here
  • Memo outlining technology opportunities here
  • Memo on the bill’s higher education provisions here
  • Memo for non-profits here
Other resources:
  • Speaker Pelosi COVID toolkit here
  • Senate Republican COVID Policy Response overview here
  • Factsheet on accelerated and advance payments for providers/suppliers here
  • Senate Small Business Committee FAQ on Paycheck Protection Program here
  • FAQ on Small Business Administration’s loan programs here
  • House Ways and Means FAQ on Rebates here
  • House Ways and Means FAQ on Unemployment Compensation here
  • House Appropriations overview for local governments/nonprofits here
Supplemental II – Families First Coronavirus Response Act (HR 6201)

The Senate passed the House bill on March 18 and the President signed the bill into law that evening. Bill text here. Factsheet here. Bill section by section here. A summary of paid leave provisions, incorporating changes made by technical correction, is here.
 
Supplemental I –Coronavirus Supplemental

Signed by the President March 6. Text here, summary here.
 
Congress

Session: House is in recess until March 31, but will be in a pro forma session until April 20. Senate is in recess until April 20.
 
Appropriations: As of right now, the appropriations markup schedule is unchanged. Most House bills have subcommittee markup dates the weeks of April 21 and April 28, while the Senate has not yet set its markup dates.
 
Remote voting: Speaker Pelosi and Leader McConnell have both voiced opposition to members’ voting remotely, but as more members of Congress have begun self-quarantining and the pandemic makes travel more treacherous, in-person voting has become more difficult. Remote voting is being discussed to some extent in both chambers. On Monday, the House Committee on Rules Majority released a staff report on voting options. The report discusses unanimous consent, proxy voting, as well as the logistics (and security concerns) of remote voting. Additionally, the House Sergeant at Arms and the Attending Physician released guidance for voting, including procedures for voting in shifts for roll call votes. In the Senate, Sens. Durbin, Portman, and Klobuchar working on a way for Senators to vote remotely, but Leader McConnell, as of right now, is not supportive. 
 
Hearings: While most hearings and markups for the next week or so have been cancelled, some committee staff are working to see whether holding hearings virtually is possible. The Senate Armed Services Committee has developed a “paper hearing” model in lieu of in-person hearings.

Members of Congress in Quarantine or Treatment (new additions in bold)

Tested Positive (6): Sen. Rand Paul (R-KY), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL), Rep. Joe Cunningham (D-SC), Rep. Mike Kelly (R-PA), Rep. Nydia Velazquez (D-NY)

Currently Self-Quarantined (28): Rep. Julia Brownley (D-CA), Rep. Jason Crow (D-CO), Rep. Matt Gaetz (R-FL), Rep. Doug Collins (R-GA), Rep. Steve Scalise (R-LA), Rep. Ann Wagner (R-MO), Rep. Ben Ray Luján (D-NM), Rep. Kathleen Rice (D-NY), Rep. Kendra Horn (D-OK), Rep. Matt Cartwright (D-PA), Rep. Ben McAdams (D-UT), Rep. Gwen Moore (D-WI), Rep. Frederica Wilson (D-FL), Rep. Stephanie Murphy (D-FL), Rep. Drew Ferguson (R-GA), Rep. Joe Cunningham (D-SC), Rep. Tom Cole (R-OK), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Andy Kim (D-NJ), Sen. Rick Scott (R-FL), Sen. Cory Gardner (R-CO), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT), Rep. Katie Porter (D-CA), Rep. Josh Harder (D-CA), Rep. Seth Moulton (D-MA),

Completed Quarantine (6): 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. Paul Gosar (R-AZ)

Other Federal Actions
  • After last week’s passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, members of Congress are now looking ahead to a fourth supplemental funding package.
  • President Trump on Sunday issued a major disaster declaration for Washington, D.C., marking the 22nd state/territory to receive a major disaster declaration and federal assistance from FEMA. The declaration allows states and territories to access federal funds to combat the coronavirus.
  • The Capitol Visitor Center and House and Senate office buildings will be closed to the public through May 1st.
  • The Department of Labor (DOL) has posted additional Questions and Answers regarding implementation of certain provisions of the Families First Coronavirus Response Act (FFCRA). 
  • CMS today announced an array of temporary regulatory waivers and new rules to increase flexibility within the health care system and improve response to COVID-19. 
  • Rep. Nydia Velasquez (D-NY) is the most recent member of Congress to receive a presumptive positive test result for COVID-19. She joins Reps. Joe Cunningham (D-SC), Mike Kelly (R-PA), Mario Diaz-Balart (R-FL), and Ben McAdams (D-UT) and Sen. Rand Paul (R-KY). Twenty-eight other members are in self-quarantine and six members have completed a self-quarantine.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are total cases: 140,904  travel-related: 886  “close contact”: 2,351 The CDC now updates data Monday through Friday and data closes out the day before reporting.
    • The CDC is reporting 2,405 deaths in the U.S. related to COVID-19.
  • California Gov. Gavin Newsom announced the release of the state’s emergency stockpile of 21 million N95 respirators, all of which are expired. While the expired masks still have effective filtering capacity, the elastic bands may have lost their resilience.
  • New York City’s 911 system has reportedly been completely overwhelmed by COVID-19 medical distress calls. On a typical day, the system will receive about 4,000 emergency medical services (EMS) calls; however, on Thursday of last week, the service received more than 7,000 calls. The record for amount of calls in a day was broken three times in the last week.
  • Also in New York City, Mayor Bill de Blasio received 250,000 facemasks for health workers as a donation from the United Nations.
  • Governors across the country continue to express concern at the lack of testing available for their residents. Montana, for example, was attempting to perform contact tracing (tracking people who have had contact with individuals who test positive) but they do not have adequate testing to keep up.
  • Maryland, Virginia, and D.C. are now all under stay at home orders by their respective governors. Virginia Gov. Ralph Northam signed his state’s into place until June 10th, the latest one so far.
    • Approximately three-fourths of Americans are either currently under stay at home orders or will be soon.
    • 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.
  • The USNS Comfort arrived in New York this morning. The 1,200-person vessel will take on non-COVID-19 patients facing life-threatening ailments to alleviate the burden of the city’s increasingly overflowing hospitals. The Navy’s other hospital ship, the Mercy, arrived in Los Angeles Friday with an identical mission.
    • The Defense Logistics Agency (DLA) is contributing over $2 million in pharmaceuticals and medical supplies, 975,000 gallons of fuel, as well as food and repair parts for both the USNS Comfort and Mercy.
International Affairs
  • Austria will require all residents to wear face masks when they shop for groceries starting this week, joining the growing ranks of experts who have questioned the prevailing guidance that healthy people don’t need to wear masks. The WHO has asserted from the beginning that masks should only be worn by the sick and health care providers, which has caused tension all over the world because of the PPE shortage. On the other hand, places like Hong Kong, where wearing masks started almost immediately, have managed to contain outbreaks.
  • In Israel, COVID-19 is spreading nearly eight times faster in ultra-Orthodox communities than in others. In the Tel Aviv suburb of Bnei Brak, where 95 percent of the residents are ultra-Orthodox, the number of confirmed cases nearly doubled in the last three days, from 267 on Friday to 508 today. 
  • China’s claims that spread has mostly stopped are being questioned. While the official Chinese count is only 82,000 confirmed cases, the number only includes individuals who test positive AND get sick. It excludes anyone who is asymptomatic. Health officials will be keeping a close eye on cases as China begins to lift lockdown measures.
  • Prime Minister Pedro Sánchez of Spain has tightened lockdown restrictions, now allowing only essential workers to leave their homes. This will last until at least April 9th.
  • Italian government officials have voiced that their national lockdown will also be extended beyond April 3rd. Timing will be decided by the Prime Minister and the cabinet.
  • Individuals in Britain should not expect things to go back to normal in fewer than six months. Their lockdowns will be reassessed every three weeks.
  • Facebook and Twitter took down posts featuring Brazil’s president, Jair Bolsonaro, over the past two days after he claimed that the anti-malaria drug hydroxychloroquine was a “cure everywhere” for the coronavirus and called for an end to social distancing and shelter-in-place measures in Brazil.
  • Global Cases:  693,224    Total Deaths:  33,106
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 Biotech Association, All rights reserved.


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