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COVID-19 Update
April 29, 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 and on YouTube.
 
Yesterday, the Iowa Department of Public Health (IDPH) was notified of 508 additional positive cases for a total of 6,376 positive cases. There have been an additional 1,165 negative tests for a total of 33,447 negative tests to date, which includes testing reported by the State Hygienic Lab and other labs. The number of positive cases will continue to grow as Test Iowa sites open and additional surveillance testing of large businesses and nursing home staff continues.  
 
According to IDPH, an additional 9 deaths were also reported. 304 are currently hospitalized, and 2,164 Iowans have recovered. At this time, 1 in 79 Iowans have been tested. At her press conference yesterday, the Governor said seven additional long-term care outbreaks have been reported in the State.
 
Governor Reynolds fielded a question about the state budget. She said she will be resubmitting a revised budget to the legislature, and she is working on that this week. She said her new budget will not include her sales tax plan that had been her priority for the legislative session.
 
Deputy Director of IDPH Sarah Reisetter spoke at the Governor’s press conference about the Iowa Restaurant Association and IDPH guidance for restaurants, farmers’ markets and churches reopening in 77 counties. The full proclamation she issued Monday rolling back some social distancing restrictions is here.
 
The guidance for businesses, farmers markets and churches will be posted on the state’s coronavirus hub. Restaurants can only reopen at 50 percent capacity, only allow groups of 6 people maximum, have proper spacing and protections for workers. Farmers’ markets can have only food vendors appropriately spaced, and no entertainment will be allowed. IDPH has also developed general guidance for any businesses that will reopen in the coming weeks, including sanitizing and encouraging social distancing, as well as worker protections.
 
The Governor said Test Iowa will be opening up new testing sites soon. She wants to use the data from Test Iowa to focus on containing and managing the virus long term. She will provide more details on testing expansion today. All Iowans are encouraged to take the online assessment at www.testiowa.com
 
IowaBio Member Highlights

Merck, and the Institute for Systems Biology (ISB), Monday announced a new research collaboration to investigate and define the molecular mechanisms of SARS-CoV-2 infection and COVID-19 and identify targets for medicines and vaccines. Merck has also entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the U.S. Department of Health and Human Services, for BARDA to provide funding support for this research effort under Contract No. HHSO100201600031C.
 
Findings generated from the study will be made available to the worldwide scientific and biomedical community. Through this collaboration, scientists from ISB, health workers from the Swedish Medical Center, and a consortium of research organizations and biomedical companies will analyze blood samples and nasal swabs from Swedish Medical Center patients with SARS-CoV-2 using samples from several time points (initial presentation, acute illness and convalescence). Blood samples will be examined using proteomic, metabolomic, transcriptomics and genetic techniques to evaluate the impact of infection on different organs, and to identify potential biomarkers to predict the risk of severe disease. In addition, samples will be analyzed to create a profile of the immune response, including quantitative changes in immune cells in patients following SARS CoV-2 infection and characterization of neutralizing antibodies in samples from convalescent patients. These insights can be used to inform vaccine design and antibody therapy. For more click here.
 
Federal Actions
  • President Trump declared meat processing plants “critical infrastructure” to allow them to stay open to avoid shortages of pork, chicken, and other products. The decision has been hotly contested by unions and labor advocates who said the Administration needs to be doing more to protect workers who often work shoulder to shoulder. Meat processing plants have popped up as hotspots for infection.
  • Yesterday, the FDA posted information and resources to assist manufacturers submitting generic drug applications with bioequivalence studies that may be impacted during COVID-19.
  • On April 29th from 12:15 pm - 1:15 pm ET, 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 is hosting a webinar on April 30th at 1:00 pm about ET “Conducting Clinical Trials During the COVID-19 Public Health Emergency.”
  • There are not 93 vaccine candidates in the pipeline, one of which is from NIH.
  • Yesterday, the FDA issued a new video resource explaining Emergency Use Authorizations (EUAs), one of several tools FDA uses to help make important medical products available quickly during public health emergencies like the COVID-19 pandemic. As the video explains, EUAs provide more timely access to drugs, diagnostic tests and/or other critical medical products that can help diagnose, treat and/or prevent COVID-19. When deciding whether to issue an EUA, the FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.
  • The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller warned, Hopewell Essential Oils, offers essential oils and herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
    • The second seller warned, Santiste Labs LLC, the “DefendTM Patch,” a transdermal patch containing a “composition of botanical oils,” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention or treatment of COVID-19.
  • HHS has started distributing that last $20 billion of the $50 billion general distribution to Medicare facilities and providers impacted by COVID-19. In order to receive payment, providers eligible for the general distribution must submit required revenue information for verification, and must attest to the terms and conditions of this additional distribution. The portal for submitting this information is open linked from hhs.gov/providerrelief. Payments will go out on a rolling basis as eligible providers submit and verify the required information.
  • The CDC continues to update their dashboard, updating today their guidance about care for breastfeeding women, what to do if you are sick, and travel recommendations.
  • Agriculture Sec. Sonny Perdue announced that both Maryland and New Mexico have been approved to operate Pandemic Electronic Benefit Transfer (EBT), a new program authorized by the Families First Coronavirus Response Act (FFCRA), which provides assistance to families of children eligible for free or reduced-price meals dealing with school closures.
  • House Majority Leader Steny Hoyer (D-MD) said today that the House will not return to Washington on May 4th. This has not stopped discussions of a fourth COVID supplemental funding package, however it has shifted the timeline.
  • There are now nearly 45,000 Air and Army National Guard professionals supporting the COVID-19 crisis response at the direction of their governors, an increase of about 500 from yesterday. In addition, 43 states, three territories and Washington, D.C. have been approved for use of federal funds under Title 32.
SEC Rules for Small Biotechs

BIO reports that changes to SEC rules just went into effect that will offer welcome relief for small biotech companies and help them deliver the new medicines we need. The Securities and Exchange Commission (SEC) adopted regulatory changes providing small public companies with a temporary exemption from compliance with Sarbanes-Oxley Act of 2002 Section 404(b), which requires public companies to report on internal controls they have in place over financial reporting.

Section 404(b) is well intended—but it’s been proven to reduce company market values, increase audit fees, force companies to exit public markets, and reduce R&D investments in pre-revenue startups, and thus, lead to less innovation. 

But without an exemption, it’s estimated it would cost small companies more than $800,000 to comply, forcing small biopharmas that do not generate revenue to choose between spending their limited funds on critical research or on filing paperwork with the SEC.

Now, thankfully, some small, public companies are exempt—specifically, companies with public float of less than $700 million and annual revenues less than $100 million.

The amendment to the rule went into effect April 27. BIO has long advocated for the change (examples here and here).

Why it matters, especially now: Many small biopharmas with little to no revenue (yet) are working on the frontlines of the coronavirus pandemic. They need every dollar they can get to fund important R&D on vaccines, treatments, and cures for COVID-19 and other deadly diseases. This change provides these companies with temporary relief from a burdensome and expensive regulatory obligation with few economic or societal benefits—allowing them to focus on the science that will lead the world out of the crisis.

Background: Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are total cases: 981,246 and 55,258 deaths  The CDC data closes out the day before reporting, and most reports are saying that, as of today, the U.S. has surpassed one million cases.
  • New York State and New York City both reported their second consecutive day of decreasing daily rate of new COVID-19 cases.
  • The number of virus patients newly admitted to hospitals in New York State has fallen more than 70 percent since the outbreak’s peak this month.
  • A recent survey asked all 50 states, Puerto Rico, and D.C. about their contact tracing capacity. Many states responded that they intend to hire a significant number of contact tracers, like Texas, which is trying to reach 5,000.
  • Updates on Lockdowns/Reopening:
    • Maine Gov. Janet Mills (D) extended her state’s stay-at-home order until May 31st, and also outlined a four-stage plan to reopen the state’s economy.
    • Alabama Gov. Kay Ivey (R) announced Tuesday the state will begin reopening the economy in a series of phases beginning Thursday at 5:00 pm.
    • Massachusetts Gov. Charlie Baker (R) said today that he will extend the limit on gatherings and the closures of nonessential businesses in his state until May 18th.
    • California Gov. Gavin Newsom (D) on Tuesday outlined the phased reopening plan for his state. The Governor said the state is currently in the first phase, marked by ongoing efforts to provide a financial safety net for low-wage earners who might otherwise work when sick and encouraging the use of face coverings by residents when in places where they cannot practice safe physical distancing. A written plan has not yet been published on the Governor’s website.
    • Colorado Gov. Jared Polis (D) continued to provide additional details on the state’s new “safer at home face” which is in effect for the next 30 days. The state launched a new website and list of frequently asked questions about the new reopening phase.  
    • Washington Gov. Jay Inslee (D) announced the partial re-opening of some outdoor recreation activities. As of Tuesday, May 5th, some outdoor recreation will be allowed with appropriate safety precautions, including: fishing; hunting; playing golf; and day use at state parks, state public lands managed by the Department of Natural Resources and at state Fish and Wildlife areas.
  • Useful state data:
    • The NYT is now 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.
    • 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
  • WHO has published the R&D Blueprint: COVID-19 Experimental Treatments, which lists drug and non-drug experimental treatments for COVID-19.
  • Spain is launching a nationwide seroprevalence study of 36,000 randomly selected households. The study will measure the level of COVID-19 throughout the population, and will use two kinds of serology tests: a finger-stick rapid test and a laboratory-based test.
  • New Zealand has now transitioned its COVID-19 response to “Alert Level 3,” which lifts some of the strictest movement measures and allows certain businesses to reopen. The country’s success in controlling the spread of COVID-19 is due in part to its rapid response, strict enforcement of boarder closure, social distancing, and testing capacity.
  • The United Arab Emirates is beginning to relax social distancing measures despite cases nearly doubling over the past 10 days. The country will use a smartphone app to support contact tracing efforts, but using the app appears to be voluntary.
  • Colombia will reportedly extend its national social distancing measures until May 11th, but began allowing construction and manufacturers to return to work on April 27th. Mass transit services may not exceed 35 percent capacity until further notice.
  • Chilean President Sebastián Piñera unveiled the country’s “Plan for Safe Return,” which plans for the return of civil service workers and private industry employees to work, and students to schools.
  • Ecuador is beginning to asses ways to relax social distancing policies, despite being among the most severely affected countries in the Pan American Health Organization.
  • Today, Turkey sent a military cargo plane loaded with personal protective equipment and other medical supplies to the U.S. Turkey’s COVID-19 epidemic has been on the decline since early April, and the Turkish government has sent similar shipments to at least 55 countries
  • Global Cases:  2,954,222         Total Deaths:  202,597
Latest on the Virus
  • Moderna said it has submitted a new-drug application with the FDA to evaluate the vaccine candidate, mRNA-1273, in a more extensive study if supported by safety data from an initial study. The phase 2 study is expected to begin in the second quarter and will evaluate the safety and any adverse reactions and immune responses of two mRNA-1273 vaccinations given 28 days apart. Each person participating in the study will be assigned to receive a placebo or different doses of the vaccine candidate. The plan is to enroll 600 healthy adults and older adults in two cohorts. Participants will be followed through 12 months after the second vaccination.
  • Coronavirus patients with lung cancer, blood cancer, or cancer that has spread beyond its original site are at greater risk than cancer-free patients for severe COVID-19, according to a new study of patients in Hubei Province in China.
  • Chinese scientists say the novel coronavirus will not be eradicated, adding to a growing consensus around the world that the pathogen will likely return in waves like the flu. According to the researchers, it’s unlikely the new virus will disappear the way its close cousin SARS did 17 years ago, as it infects some people without causing obvious symptoms like fever. This group of so-called asymptomatic carriers makes it hard to fully contain transmission as they can spread the virus undetected.
  • The National Academies of Sciences held their annual meeting from April 25th-27th. During one panel discussion, Dr. Tony Fauci and other panelists explored the status of the pandemic, research underway, and the key role of vaccines in bringing the pandemic to an end. The video is available here.
Lifestyle, Science, and Economy
  • A prominent model used by the White House to predict the trajectory of the coronavirus outbreak on Monday revised its estimated death toll sharply upward, and is now projecting COVID-19 could result in more than 74,000 deaths across the U.S. by early August. The model was produced by researchers at the University of Washington’s Institute for Health Metrics and Evaluation and has been frequently referenced by top administration officials. Its forecast now projects 74,073 deaths in the U.S. by August 4th — with an estimate range of 56,563 to 130,666. Because the forecast cuts off before the fall, when many epidemiologists anticipate a second wave of the outbreak to hit the U.S., even that revised projection could be a gross underestimate.
  • A St. Louis health care system has implemented a process to disinfect disposable N95 respirator masks that allows health care workers to reuse their own mask for up to 20 cycles. The novel disinfection process uses vaporized hydrogen peroxide. Test results from a pilot program at Barnes-Jewish Hospital and two other hospitals that are also part of BJC HealthCare, showed that the disinfection process kills germs from N95 masks while ensuring that the only person who touches the mask is the original mask wearer.
  • Dr. Tony Fauci said it will be very difficult for professional sports teams to return to competition, with the key variable being the availability of access to tests. He said any resumption of play should be done gradually and carefully, and when cases begin to increase again, that “we have the capability of identifying, isolating and contact tracing.”
  • About 1 in 7 Americans say they would avoid seeking medical care if they experienced key symptoms associated with COVID-19 out of fear of the potential cost. Another six percent - representing about 15 million people - report that they or a family member have been denied medical care for some other health issue due to heavy volume brought on by the coronavirus outbreak. The findings, released today by the nonprofit West Health and Gallup as part of a series on the rising cost of healthcare in the U.S., come from a nationally representative survey of 1,017 U.S. adults conducted between April 1st and 14th.
  • Simon Property Group, the biggest operator of malls in the U.S., has come up with a game plan for reopening 49 shopping centers across 10 states starting on Friday. Gap Inc., which owns its namesake brand as well as Athleta, Banana Republic, and Old Navy and is a tenant in some of the properties being reopened, said on Tuesday that it was not opening any stores this weekend. Macy’s, also a Simon Property tenant, currently has all of its stores closed.
  • Colleges and universities are taking huge financial blows. The University of Michigan anticipates losses of $400 million to $1 billion this year across its three campuses. California’s university system suffered $558 million in unanticipated costs in March alone. By itself, the Boulder campus of the University of Colorado will lose at least $67 million through the summer.
  • WIRED recently published “An Oral History of the Day Everything Changed,” which documents prominent Americans looking back at when they realized COVID-19 was a big deal.
  • 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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