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COVID-19 Update
May 8, 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.

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

Governor Kim Reynolds will hold a press conference today from the State Emergency Operations Center (SEOC) in Johnston, IA at 11:00 a.m. to provide an update to the state of Iowa on COVID-19. That press conference will be livestreamed and posted in full on Governor Reynolds’ Facebook Page

As of Thursday, 231 people with COVID-19 have died in Iowa and 11,059 people have tested positive, according to the Iowa Department of Public Health. On Wednesday, the state had reported a total of 219 deaths and 10,404 positive cases since the onset of the virus' arrival in Iowa. According to coronavirus.iowa.gov on Thursday, 4,266 people with COVID-19 have recovered. A total of 66,427 have been tested.

Yesterday at her press conference, the Governor spoke about her trip to Washington D.C. on Wednesday to update Iowa’s response to COVID-19 to President Trump Vice President Pence and others in his administration. Dr. Caitlin Pedati, State Epidemiologist, went with the Governor to speak about Iowa’s data and response. The Governor said Dr. Pedati did such a good job, she was invited to participate on the President’s Caronavirus Task Force, and will be the first state-level representative on the Task Force. The Governor said she was proud to relate to the President that Iowa has increased our testing capacity, and case investigation teams.

The Governor announced a revamped website, and said the coronavirus.iowa.gov dashboard will now have new features that have more visual appeal and will be more timely. The total case counts online will not match the same timeframe as the governor’s press releases, she noted. Data from the dashboard can now be exported from the website to a spreadsheet or other document formats. The data will also now represented in a way to be able to look back over time, and users can drill down to cases by county. The epicurve is now represented in multiple ways on the website, as well.

IowaBio Member COVID-19 Response Highlights

Researchers have begun giving healthy volunteers in the U.S. an experimental coronavirus vaccine developed by Pfizer Inc. and partner BioNTech SE, the latest study exploring a potential defense against the respiratory disease.

Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The novel design of the trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time.

In anticipation of a successful clinical development program, Pfizer and BioNTech are working to scale up production for global supply. Pfizer plans to activate its extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world. The breadth of this program should allow production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. Pfizer-owned sites in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium have been identified as manufacturing centers for COVID-19 vaccine production, with more sites to be selected. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity to provide further capacities for a global supply of the potential vaccine.

The Wall Street Journal: Coronavirus Vaccine Enters Human Testing in U.S.

NY Times:  Pfizer Begins Human Trials of Possible Coronavirus Vaccine

CNBC  Pfizer plans to have millions of vaccine doses by October, says chief scientist

Federal Actions
  • HHS has extended the deadline for healthcare providers fighting COVID-19 to attest to receipt of payments from the Provider Relief Fund and accept the Terms and Conditions. Providers will now have 45 days, increased from 30 days, from the date they receive a payment to attest and accept the Terms and Conditions or return the funds.
  • To date, the FDA has issued 42 warning letters to companies making bogus COVID-19 claims, including one to a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, frequently referred to as “Miracle Mineral Solution” or “MMS,” as a treatment for COVID-19. After the seller refused to take corrective action, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product.
  • Through HRSA, HHS awarded nearly $583 million to 1,385 HRSA-funded health centers in the U.S. to expand COVID-19 testing. Nearly 88 percent of HRSA-funded health centers report testing patients, with more than 65 percent offering walk-up or drive-up testing. Health centers are currently providing more than 100,000 weekly COVID-19 tests in their local communities. The funding for these centers is part of the “COVID 3.5” bill signed into law last month. Here is a list of award recipients.
  • COVID-19 hearings in Congress next week:
  • Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR) yesterday announced that the Full Committee will hold a teleconference forum today (5/8) at 12:00 PM on COVID-19 testing, contact tracing, and surveillance.
  • The CDC continues to update and publish additional documents on its dashboard. Yesterday, the CDC published updated interim guidance for tribal communities, first responders and law enforcement, and schools and child care programs. These three are just a sampling of the many updates made each day by the CDC.
  • The CDC published three new articles in the Morbidity and Mortality Weekly Report (MMWR) about COVID-19, including an article about workers in meat processing plants. This study looked at COVID-19 cases among U.S. workers in 115 meat and poultry processing facilities were reported by 19 states. Among approximately 130,000 workers at these facilities, 4,913 cases and 20 deaths occurred. Difficulties with workplace physical distancing and hygiene and crowded living and transportation conditions were listed as factors that increased risk.
  • CMS announced that nursing homes are now required to report the first week of COVID-19 data to the CDC beginning May 8th but no later than May 17th. For the first time, all 15,000 nursing homes will be reporting this data directly to the CDC through its reporting tool.
  • CMS released additional FAQs to aid state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their response to the pandemic. The new FAQs cover a variety of Medicaid and CHIP topics, including emergency preparedness and response, benefit, financing, eligibility and enrollment flexibilities, information technology, and data reporting.
  • CMS has approved over 155 requests for state relief in response to the COVID-19 pandemic, including recent approvals for Arizona, Arkansas, Colorado, Iowa, Hawaii, Maryland, New Mexico, New York, Pennsylvania, the U.S. Virgin Islands, and Washington. These approvals help to ensure that states have the tools they need to combat COVID-19 through a wide variety of waivers, amendments, and Medicaid state plan flexibilities, including support for programs that care for the elderly and people with disabilities. CMS developed a toolkit to expedite the application and review of each request and has approved these requests in record time.
  • Though the Senate returned to Washington on Monday, Democratic Whip Jim Clyburn (D-SC) has indicated the House will not return for another couple of weeks. This does not affect the passage of a fifth (or fourth, depending on how you classify 3.5) COVID-19 supplemental appropriations package quite so much as does the standoff between Republicans and Democrats on a few key issues.
  • White House officials have reportedly rejected proposed guidance developed by the CDC which aims to assist states in implementing protective measures as states begin to reopen. Officials are said to have viewed the draft guidance as “overly prescriptive,” particularly for states currently experienced low levels of transmission.
  • President Trump said today that he, Vice President Pence, and members of the White House staff will be tested every day for COVID-19 after a military aide who has had contact with the president tested positive.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 1,219,066 total cases and 73,297 deaths  The CDC data closes out the day before reporting.
  • Two restaurants in Dallas, Texas directed employees not to wear face masks as they resume dine-in operations, while a Dallas County Judge amended his local stay at home order to mandate mask use. Texas Gov. Greg Abbot (R) has prohibited local governments from “imposing civil or criminal” punishments for failure to wear a mask.  
  • The Ohio Legislature passed a bill that would require the Director of Health to apply to the legislature for approval to extend any health order issued in response to the COVID-19 epidemic. Gov. Mark DeWine (R) has reportedly confirmed that he intends to veto the bill.
  • Georgia reported yesterday that 20,000 teens in the state had been issued a driver’s license in the last month without having had to pass a road test.
  • Delaware Gov. John Carney (D) rescheduled the presidential primary for July 7th.
  • Pennsylvania Gov. Tom Wolf (D) announced that he is extending a ban on foreclosures and evictions through July 10th.
  • Updates on lockdowns/reopening:
    • Arkansas Gov. Asa Hutchinson (R) says the state’s three gaming casinos will be allowed to reopen with limited operations starting May 18th.
    • California Gov. Gavin Newsom (D) announced new COVID-19 safeguards for retail stores and workplaces eligible to reopen Friday and the following weeks.
    • Gov. Gretchen Whitmer (D) extended Michigan's stay-at-home order until May 28th, with some exceptions (like auto manufacturers, who may return to work on Monday).
    • Montana Gov. Steve Bullock (D) announced additions to phase one of his state’s reopening plan. It will allow movie theaters, gyms, and museums to reopen by May 15th.
    • Oregon Gov. Kate Brown (D) announced new guidance and a new, three-phase plan for counties and businesses to reopen.
    • Gov. Gina Raimondo (D) announced she will allow Rhode Island’s stay-at-home order to expire Saturday (5/9).
  • Useful state data:
    • The NYT is tracking which states are reopening and which are still shut down.
    • These charts show cumulative coronavirus cases and deaths for metropolitan areas over time.
    • Use Johns Hopkins University’s COVID-19 U.S. map as a resource for media, policymakers and communities to view a collection of critical public health data in one online destination and better understand and track the COVID-19 pandemic in populations both large and small across the country.
    • NASHP has developed a COVID-19 State Action Center which serves as a state-level policy dashboard. Governing is also keeping a running tally of coronavirus news and impacts at the intersection of the health and economic crises in the states and localities.
    • This site from the Kaiser Family Foundation provides state-level information on cases/deaths, social distancing measures, health policy actions, and more.
    • This resource from Bloomberg Law is a database of State Quarantine and Public Health Laws related to the COVID-19 response.
    • This series of maps shows how states are responding to COVID-19, and this tracker, created and maintained by MultiState Associates, has an up-to-date list of executive orders and various travel restrictions.
    • Finally, this site offers COVID-19 projections assuming full social distancing and can be broken down by state.
International Affairs
  • The world recorded its highest number of new cases in more than two weeks.
  • After the U.S. FDA issued an emergency use authorization for treating COVID-19 patients with remdesivir, Japan approved the drug for treatment as well.   
  • Data from England and Wales show that black individuals are twice as likely to die from COVID-19 as white people. Britain’s Office of National Statistics found two of the major factors to be social determinants of health and underlying health issues.
  • Afghanistan’s health minister, Dr. Ferozuddin Feroz, has tested positive for COVID-19.
  • Poland has postponed its presidential election, which was originally supposed to take place this Sunday. It is now expected to be put off until June at the earliest, and officials are still debating how to conduct the contest safely and fairly amid the pandemic.
  • Canada is sending hundreds more troops to long-term care centers in Quebec and Ontario as COVID-19 outbreaks contribute to a growing crisis in senior homes.
  • French Education Minister Jean-Michel Blanquer said students will be able to start returning to school on Monday. Primary schools will open across the country Monday, with classes limited to 15 students, Blanquer said. Middle-school students from regions where the rate of infection is slowing down — categorized as “green” by the French government — will be returning to school on May 18th. But middle schools in areas where the virus is still actively circulating — categorized as “red” — will not reopen.
  • While many in Italy have been allowed to go back to work, schools will remain closed until September. In a country where just over half of women are in the workforce, many are concerned they will have to choose between their jobs and caring for their children. The Italian networks that normally support families — like church, after-school programs and sports centers — have also shut down.
  • Global Cases:  3,864,696       Total Deaths:  270,020
Lifestyle, Science, and Economy
  • The Department of Labor reported that nearly 3.2 million more Americans were added to state jobless rolls last week. Economists now expect the monthly jobs report today to put the official April unemployment rate at 15 percent or higher — a Depression-era level.
  • Frontier Airlines announced yesterday that they plan to take passengers’ temperatures before boarding commercial flights. Beginning June 1st, anyone with a temperature of 100.4 degrees or higher will be denied boarding.
  • Starting Monday, Amtrak will require passengers to wear face coverings in stations and on trains and buses. The coverings can be removed only when passengers are eating in designated areas, in private rooms, or when seated alone or with a companion in their own pair of seats.
  • Several major sports leagues announced plans to resume play. The National Football League directed teams to develop plans to reopen training facilities on May 15th.
  • Food and consumer products trade groups sent a letter to Vice President Pence asking for more guidance on the steps they should take as they prepare to reopen. The groups wrote that the lack of “central coordination” from different agencies make it “extremely” difficult for companies to develop detailed response plans.
  • New York-Presbyterian Columbia University Irving Medical Center researchers found that hydroxychloroquine neither helped nor harmed COVID-19 patients at the medical center in Manhattan. As a result, the hospital is no longer recommending it as a treatment for its COVID-19 patients.
  • Moderna, one of the first biotech companies to begin human trials of an experimental vaccine for the coronavirus, said that the FDA had cleared its application to proceed to a clinical trial involving about 600 people.
  • The drop in airline travel caused by COVID-19 has sharply reduced the amount of atmospheric data routinely gathered by commercial airliners, according to the World Meteorological Organization. Apparently, sensors on planes collect data on temperature, wind, and humidity, and transmit it in real time to forecasting organizations around the world. The data collection has been cut by nearly 90 percent in some regions.
  • Forbes is keeping a running list of all major international airline COVID-19-related change and cancellation policies.
  • The New York Times has started its own tracker of cases in the U.S. to fill in the gaps left by agency data.
  • Lists of canceled conferences and events can be found here (music), here (tech), here (general), and here (sports/entertainment).
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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