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COVID-19 Update
October 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, 101,576 Iowans have tested positive, up 1,108 from our update yesterday morning, with a total of 872,286 tested. 10 additional deaths were reported since our last update, bringing the total to 1,491 deaths. Now 79,020 Iowans have recovered. The overall positivity rate is 11.6% and the total 14 day rolling average positivity rate is 9.5%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here. There are currently 473 hospitalized patients.

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 18 counties are above 15 percent positivity rate over the past 14 days:

Sioux 25.0%
Harrison 21.5%
Carroll 21.0%
Taylor 20.6%
Lyon 20.1%
Fremont 19.2%
Plymouth 18.5%
Emmet 18.0%
Monroe 17.9%
Crawford 17.8%
Delaware 17.7%
Page 17.4%
Guthrie 17.2%
Decatur 17.1%
Montgomery 16.9%
Osceola 16.4%
O’Brien 16.0%
Woodbury 15.2%

Yesterday LSA published a report on the Business Disruption Relief Program created to help bars, and other establishments that were temporarily shut down in targeted counties, due to COVID-19. The Program provided grants to bars, taverns, and other establishments impacted by the August 27, 2020, COVID-19 disaster proclamation, which closed bars in six counties: Black Hawk, Dallas, Johnson, Linn, Polk, and Story. The document says $2.6 million was awarded, and contains a link to a list of the establishments that received the awards.

Federal Actions
  • President Trump has tested negative for COVID-19 on consecutive days according to White House Physician Sean Conley.
  • The NIH's National Cancer Institute (NCI) has launched the Serological Sciences Network for COVID-19 (SeroNet), an initiative aimed at quickly increasing the nation’s antibody testing capacity and engaging the U.S. research community to understand the immune response to COVID-19. SeroNet will engage more than 25 of the nation’s top academic, government and private sector biomedical research institutions to study the immune response to COVID-19 to speed delivery of testing, treatments and vaccine development for combat the pandemic.
  • NIH's NIAID yesterday launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials. The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized with COVID-19 at as many as 40 U.S sites, is being conducted in collaboration with the NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program. 
  • NIH Director Dr. Francis Collins penned a new blog in which he highlights some recent vaccine trial success, including one that indicates the Moderna vaccine candidate is both well tolerated and effective in generating a strong immune response when given to adults of any age.
  • Monday the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular influenza (flu) viruses and respiratory syncytial viruses (RSV) tests require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify RSV.
  • The FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of September 30, 2020, 550+ drug development programs were in planning stages, 350+ trials were reviewed by FDA and 5 COVID-19 treatments were currently authorized for emergency use.
  • The FDA released a statement reaffirming its commitment to the safety and security of its public health laboratories. 
  • As of Tuesday, 279 tests are authorized by FDA under EUAs; these include 217 molecular tests, 56 antibody tests, and 6 antigen tests.
  • CDC has a new webpage that features new ways of trick or treating and other Halloween activities. When trick or treating or participating in other Halloween activities with people outside your household, wear a mask. The agency encourages people to make it fun by making your mask part of your costume, but when it comes to slowing the spread of COVID-19, a costume mask is not a substitute for a cloth mask. They also say not to wear a costume mask over a cloth mask as it can make breathing more difficult. 
  • HHS and DoD announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company's COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent COVID-19. 
  • HHS and DoD also announced an agreement with Cytiva, headquartered in Massachusetts, to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines. BARDA collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide approximately $31 million to Cytiva for vaccine-related consumable products, such as liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors.
  • In their final act of the day, HHS and DoD awarded a $481 million Other Transaction Agreement to Cue Health, Inc. to expand U.S. production capacity for a cartridge-based point-of-care COVID-19 molecular test that produces results in about 20 minutes. This partnership with HHS and DOD will allow Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021, and demonstrate this capacity through the delivery of six million COVID-19 tests and 30,000 instruments to the U.S. Government to support the domestic COVID-19 pandemic response.
  • CMS released a statement about the integrity of COVID-19 testing. 
  • Though numbers have been tossed around, letters have been sent, and negotiations have continued, there is still no pandemic relief bill on the table. Senate Majority Leader Mitch McConnell (R-KY) said yesterday that the Senate will take up another skinny bill when it comes back in session next week. It almost certainly won't be in line with what House Speaker Nancy Pelosi (D-CA) has expressed Democrats need to see. 
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 7,787,548 total cases and 214,446 deaths The CDC data closes out the day before reporting. The 7-day average of new cases in the U.S. is now over 50,000.
  • Since Saturday, more than 20 states have hit a new high in their seven-day average of reported case counts, and more than half of those states set records again yesterday.
  • North Dakota and South Dakota are reporting more new cases per person than any state has previously.
  • More than 100 of New Jersey’s long-term care facilities experienced fresh coronavirus outbreaks this summer or fall after they were declared free of the virus. Eleven of those facilities had residents or staff members die in the new round of increased spread.
  • Illinois Gov. J.B. Pritzker (D) and the Illinois Department of Public Health announced that Region 4, the Metro East, will return to Phase 4 of the Restore Illinois Plan.
  • Colorado Gov. Jared Polis (D) amended and extended an EO requiring mask-wearing indoors to help stop the spread of the virus. 
  • Gov. Polis also extended an EO allowing for the operation of alternate care sites in response to COVID-19.
  • Connecticut Gov. Ned Lamont (D) announced the members he is appointing to serve on the Governor’s COVID-19 Vaccine Advisory Group. The group will be responsible for advising the governor on preparations for a COVID-19 vaccine, including the optimization of a statewide vaccine distribution strategy, and communicating critical medical information about the vaccine with the state’s residents.
  • New York Gov. Andrew Cuomo (D) announced that COVID-19 rapid result testing will be made available to every county in New York State. The New York State Department of Health will deploy an initial 400,000 rapid result test kits free of charge to local health departments, hospitals, pharmacies, and other health care providers to help increase access in all corners of New York State to free COVID-19 tests that can be done within 15 minutes and without having to send a specimen to a lab. DOH will prioritize the distribution of testing kits to counties and local health care providers in areas seeing a recent uptick in cases. 
  • Last week, Louisiana Gov. John Bel Edwards (D) announced that Louisiana will stay in Phase 3, keeping its strong COVID-19 mitigation measures, including a continued statewide mask mandate, in place for another 28 days. 
  • 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
  • You can view the WHO's Weekly Epidemiological Update here and the Operational Update here
  • The Chinese city of Qingdao is testing all of its 9.5 million residents after it recorded the country’s first locally transmitted cases of the virus in almost two months.
  • Human trials of Russia's Sputnik V COVID-19 vaccine have begun in the UAE, the Kremlin said Monday. The trials in the UAE are the second trials of the Sputnik V vaccine abroad, following the launch of trials in Belarus. Scientists around the world are skeptical of the safety and efficacy of the vaccine due to its small trials and rapid development. 
  • The Dutch government has ordered bars and restaurants to close in an effort to stem a surge in COVID-19 cases. Additionally, there is a ban on alcohol sales after 8 PM, and a limit on the number of people who can attend household gatherings.
  • Italian prime minister Giuseppe Conte announced new restrictions on gatherings, restaurants, sports, and school activities to help control the rapidly increasing number of infections.
  • As case numbers rise in Europe, the E.U. adopted new guidelines aimed at coordinating members’ varying travel measures. The bloc will now use a single map with a color-coded system to denote the scale of outbreaks: green at the low end of risk, orange in the middle and red at the high end.
  • At the end of last week, the number of coronavirus infections in France jumped over 20,000 in one day for the first time since the start of the pandemic. Yesterday, the French healthcare system's chief said hospitals in Paris could fill 90 percent of ICU beds as early as next week.
  • Spain declared a state of emergency to help keep Madrid in partial lockdown measures. 
  • Canadian health officials have said Canadian children can go trick-or-treating on Halloween, despite being in the middle of a second wave of COVID-19, as long as they practice physical distancing, wear masks, and wash their hands.
  • In the Czech Republic, where there have been more cases per capita in the last week than almost all other countries in Europe, schools will close Wednesday. 
  • Eighteen members of Tunisia’s Parliament have tested positive for COVID-19.
  • Germany added Munich to its list of coronavirus “red” zones yesterday, triggering new COVID-19 restrictions as the country deals with a rise in cases.
  • Global Cases: 38,195,651     Total Deaths: 1,087,343
Lifestyle, Science, and Economy
  • Johnson & Johnson's COVID-19 vaccine clinical trial has been paused. The pause, which is not a regulatory hold, is due to an "unexplained illness" in a study participant, and will remain in place until researchers have been able to prove the illness was not caused by the vaccine.
  • Drugmaker Pfizer has announced an additional modification to the protocol for its late-stage study of its COVID-19 vaccine, this time to include more young participants. The company said on Monday that it has received permission from the FDA to include adolescents aged 12 through 15 in its global COVID-19 vaccine study.
  • Eli Lilly's antibody treatment clinical trial has been paused due to a "potential safety concern." The Eli Lilly trial was designed to test the benefits of the therapy on hundreds of people hospitalized with COVID-19, compared with a placebo.
  • A recent study published in the Annals of the American Thoracic Society suggests that wearing masks does NOT increase carbon dioxide levels in patients with chronic lung disease. 
  • The Black Doctors COVID-19 Consortium has increased access to coronavirus testing in the Philadelphia region, testing more than 10,000 people. The group’s mobile unit and pop-up testing sites also offer patients an opportunity to connect with African American health care providers. Read more here
  • An elderly woman in the Netherlands has died after getting COVID-19 a second time, researchers reported on Monday. It’s the first time a death has been reported from reinfection with coronavirus. To date, researchers have confirmed only 23 cases of reinfection, but in all prior cases the patient recovered.
  • A 25-year-old man in Nevada is the first recorded case of reinfection in the U.S.
  • Data from Japan, Spain, and Italy indicate that an individual's age does not indicate how likely they are to be infected with coronavirus, despite age playing a significant role in how likely an individual is to survive if infected. 
  • A new Viewpoint published in JAMA suggests COVID-19 will end up costing people in the U.S. around $16 trillion. The paper aggregates mortality, morbidity, mental health conditions, and direct economic losses to estimate the total cost of the pandemic in the US on the optimistic assumption that it will be substantially contained by the fall of 2021.
  • Also in JAMA, researchers say far more Americans have died as a result of the COVID-19 pandemic than have been counted and reported. The study found that from March through July, there were 225,530 "excess" deaths — a 20 percent increase over the average number of deaths expected for those months. About 67 percent of those deaths are directly linked to COVID-19, but the remaining 33 percent could be a result of underreporting/misreporting or deaths that came as a result of disruptions to acute care during the pandemic.  
  • Portuguese soccer phenomenon Cristiano Ronaldo has tested positive for COVID-19. 
  • The Ruby Tuesday restaurant franchise filed for bankruptcy last week. 
  • 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 New York Times has a very helpful vaccine tracker as well, which you can view here
  • BIO’s COVID-19 pipeline tracker 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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