Copy
View this email in your browser
COVID-19 Update
September 24, 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, 83,341 Iowans have tested positive, up 1,667 from our update yesterday morning, with a total of 758,494 tested. 5 additional deaths were reported since our last update, bringing the total to 1,298 deaths. Now 61,452 Iowans have recovered. The overall positivity rate is 11.0% and the total 14 day rolling average positivity rate is 9.1%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.

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 14 counties are above 15 percent positivity rate over the past 14 days:
Sioux 30.6%
Osceola 27.3%
Lyon 23.0%
Crawford 22.6%
Audubon 20.0
Henry 19.9%
Sac 19.5%
Plymouth 19.4%
Fremont 17.5%
Ida 16.9%
Dubuque 16.4%
Woodbury 15.7%
Winnebago 15.3%
Cherokee 15.0%

The following information on vaccine distribution planning was kindly provided to IowaBio by the Iowa Medical Society:

The Iowa Department of Public Health has convened a stakeholder workgroup, comprised of IMS and other leaders within the provider and public health community, to assist with planning and distribution of an anticipated COVID-19 vaccine.

On September 23, the workgroup held its initial meeting to discuss state planning efforts and impending next steps to help prepare the provider and public health community. The state is finalizing its plans for planning and distribution of the COVID-19 vaccine, as well as communications and engagement with both the public and provider communities. The workgroup will serve as a component of helping to consistently and rapidly distribute this information.

Each state is required to submit an initial plan to the CDC by October 16, with plans being finalized by November 1, 2020. Following this, IDPH will be responsible for submitting twice weekly reports to the CDC outlining provider capacity for administering the vaccine, along with additional data elements that will be captured in a forthcoming recap survey and subsequent COVID-19 Vaccination Provider Agreement.
Final patient prioritization criteria for the limited initial doses of the COVID-19 vaccine may vary based upon the results of the Phase 3 clinical trials. State officials anticipate that Iowa will largely follow the CDC guidelines, laid out in the COVID-19 Vaccine Program Interim Playbook, which prioritize administration to front-line medical workers and seniors in long term care facilities. Upon federal approval of a COVID-19 vaccine, the State Infectious Disease Workgroup along with State Medical Director and Epidemiologist Caitlin Pedati, MD, will determine if any Iowa-specific variations from these guidelines are necessary.

The leading contenders for a COVID-19 vaccination require cold storage well beyond that of a traditional vaccine. Some require storage at -60° to -80° C, while others require storage at -20° C. State and federal officials caution against clinics investing in new cold storage equipment in anticipation of a COVID-19 vaccine. As part of the clinical trials, manufacturers are testing the ability to store these vaccines for a short period of time immediately prior to administration in either a traditional freezer or on dry ice like that which will be used when the vaccines are shipped. Initial indications are that these leading contenders can be safely stored in this manner for a matter of a few days, possibly up to a week. Additional information on storage will be circulated closer to distribution.

Yesterday, Governor Reynolds announced awards to 65 applicants for the Coronavirus Relief Fund Employer Innovation Fund Grant.  The program will assist local employers, nonprofits, community colleges, high schools, private universities, and the University of Iowa provide postsecondary training and education to Iowans whose employment has been impacted by the Coronavirus pandemic.  More than $4.3 million has been awarded to the winning projects. 

“Future Ready Iowa’s Employer Innovation Fund is centered around a grassroots effort to solve local workforce challenges while helping Iowans find economic opportunity in their community. The winning projects address barriers for Iowans who have lost their jobs due to the pandemic by providing training opportunities that will build on our economic recovery,” said Gov. Reynolds. “These programs not only help those affected by the pandemic, they will also focus on recruiting our minority and underrepresented communities to help us diversify our workforce and provide equal chances for success for all Iowans.”

The Coronavirus Relief Fund Employer Innovation Fund grants can be used to cover the cost of training, books, and equipment as well as often providing much needed wrap-around support that address other barriers some Iowans face when trying to obtain skills training.

“Once again, employers, nonprofits and educators have come up with amazing and innovative solutions to help their fellow Iowans by creating training opportunities in high demand occupations,” said Director Beth Townsend, Iowa Workforce Development.  “From IT, healthcare, advanced manufacturing to first responders, these programs will help expand our skilled workforce, diversify our workplaces and help those most affected by the pandemic.” 

The Future Ready Iowa goal is to have 70 percent of Iowans in the workforce with education and training beyond high school by 2025.  Approximately 60 percent of Iowa’s current workforce meets this education and training criteria.  Visit www.FutureReadyIowa.gov for more information.

IowaBio Member Highlights

Yesterday, J&J announced the launch of its large-scale, pivotal, multi-country Phase 3 ENSEMBLE clinical trial study in the United States.
 
The initiation of the ENSEMBLE trial follows positive interim results from J&J’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. Based on these results and in discussions with FDA, ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. J&J will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles. J&J is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including details of the study protocol which is available here.
 
Built on a legacy of commitment to diversity and inclusion, J&J aims to achieve representation of populations that have been disproportionately impacted by the pandemic in the implementation of our COVID-19 Phase 3 trial program. In the U.S., this includes significant representation of Black, Hispanic/Latinx participants, American Indian and Alaskan Native.
 
Johnson & Johnson has continued scaling up of its manufacturing capacity and remains on track to meet the goal of providing a global supply of more than one billion doses of a vaccine. With Janssen’s AdVac® technology, the vaccine remains stable at 2-8° C for three months. This makes it compatible with standard vaccine distribution channels and will not require new infrastructure to get it to the people who need it.
 
The development of the COVID-19 vaccine builds on J&J’s efforts to develop new vaccines and treatments to combat a wide range of infectious diseases that are already pandemics, such as HIV and tuberculosis (TB), or that have pandemic potential, including Ebola and Zika. J&J believes that global health security is everyone’s responsibility and requires coordinated effort from governments, civil society and the private sector. The Janssen COVID-19 vaccine candidate leverages the AdVac® technology platform, which was also used to develop and manufacture Janssen’s recently approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. This technology platform has been used to vaccinate more than 100,000 people to date across Janssen’s investigational vaccine programs. J&J is proud to contribute to global efforts to combat the COVID-19 pandemic and make the world better prepared for emerging threats.
 
Federal Actions
  • The FDA said they plan to issue stricter guidelines for the EUA of any new COVID-19 vaccine, adding a new layer of caution to the vetting process. The new guidelines would lay out more specific criteria for clinical trial data and recommend that the data be vetted by a committee of independent experts before the FDA authorizes any vaccine. Yesterday, however, President Trump suggested he would consider not approving such guidelines. 
  • CMS released preliminary Medicaid and Children’s Health Insurance Program (CHIP) data revealing that, during the COVID-19 public health emergency, rates for vaccinations, primary, and preventive services among children in Medicaid and CHIP have steeply declined. This decline may have significant impacts on long-term health outcomes for children, as Medicaid and CHIP cover nearly 40 million children, including three quarters of children living in poverty and many with special health care needs that require health services. A data analysis found there were 1.7 million fewer vaccinations given to Medicaid beneficiaries 2 or younger, a drop of 22 percent, and 3.2 million fewer screenings to detect autism or developmental delays, a drop of 44 percent. Dental care dropped by 69 percent, with 7.6 million fewer tooth cleanings and other services. CMS published a Fact Sheet: Service Use among Medicaid & CHIP Beneficiaries age 18 and Under during COVID-19.
  • HHS announced that the CDC will provide $200 million to jurisdictions for COVID-19 vaccine preparedness. The money will go to 64 jurisdictions through the existing Immunizations and Vaccines for Children cooperative agreement. These funds, along with the previous support CDC has provided, will help states prepare for the COVID-19 vaccine.
  • The NIH announced it has expanded clinical trials to test convalescent plasma against COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and neutralize SARS-CoV-2, the virus that causes COVID-19, as well as other components that may contribute to an immune response. The trials are receiving money from OWS and hope to have results as early as this fall.
  • The CDC's September 22 Science Update is here. The Science Update series provides brief summaries of new COVID-19-related studies on many topics, including epidemiology, clinical treatment and management, laboratory science, and modeling.
  • 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 will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
    • September 30, 12:15 PM
  • USDA announced the extension of more than a dozen flexibilities ensuring participants in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) continue receiving the food and health support they need during the COVID-19 pandemic. USDA’s proactive extension of these waivers throughout the national public health emergency will ensure nutritionally at-risk mothers, babies, and children receive the critical nutrition benefits and services they count on in a safe manner while allowing the program to operate based on local conditions throughout the pandemic.
  • The Senate Committee on Health, Education, Labor, and Pensions (HELP) met today to hear testimony from four of the country's top health officials about the Federal Response to COVID-19. Members sought information about the vaccination development and review process, pressed for commitments that all public health agency decision-making would be based on science and data, and criticized what they deemed to be a lack of clear communication regarding public health guidance. Witnesses repeatedly assured members that the review process for vaccines, treatments, testing, and other public health guidelines are based on science and directed by career professionals at their agencies. A memo of this hearing is available upon request. 
  • Thirty-four Senate Democrats, led by Minority Leader Chuck Schumer (D-NY) and Patty Murray (D-WA), the ranking member of the Senate HELP Committee, introduced the Science and Transparency Over Politics (STOP) Act in light of a flood of accusations that agencies such as the CDC and FDA were pressured to tailor their talking points and reports to align with the White House’s narrative of the pandemic response. Many members in today's HELP hearing asked questions along these lines, suggesting political interference in scientific documents. 
  • There is still no coronavirus relief package on the table and negotiations are likely to be stalled for a while.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 6,874,982 total cases and 200,275 deaths The CDC data closes out the day before reporting.
  • The U.S. is now mourning the loss of over 200,000 individuals from COVID-19. 
  • Connecticut, New York, and New Jersey's regional travel advisory has been updated: Arizona, Minnesota, Nevada, Rhode Island, and Wyoming have been added to the list of impacted locations that have met the metrics to qualify. No areas were removed this week. 
  • New Mexico amended the list of states from which visitors and arriving residents must quarantine. Colorado, Oregon, and Rhode Island have been added to the list of high-risk states. 
  • Wisconsin Gov. Tony Evers (D) declared a new public health emergency due to a recent surge in cases among young people. Gov. Evers also issued a new face coverings order effective immediately. 
  • Washington Gov. Jay Inslee (D) issued guidance for miscellaneous venues, including convention/conference centers, designated meeting spaces in hotels, events centers, and other similar venues as part of Washington's Safe Start phased reopening plan. 
  • Connecticut Gov. Ned Lamont (D) announced that he is creating a working group to prepare Connecticut for the potential development of a COVID-19 vaccine. The governor’s COVID-19 Vaccine Advisory Group will be responsible for optimizing a statewide vaccine distribution strategy and communicating critical medical information about the vaccine with the state’s residents.
  • Maine Gov. Janet Mills (D) and the Commissioner of Health and Human Services announced that anyone in Maine can now get tested for COVID-19 without the need for a separate order from a health care provider, a milestone resulting from Maine's vastly expanded testing capacity.
  • Indiana Gov. Eric Holcomb (R) announced that the state would gradually enter Phase 5 of reopening, from September 26 to October 17. Residents will still be required to wear face coverings and maintain social distancing, but size limits on social gatherings and meetings will be lifted and restaurants, bars, and nightclubs will be allowed to operate at full capacity.
  • Students in Miami-Dade County, the fourth-largest school district in the country and the largest in Florida, will be able to choose to return to their classrooms next month under a plan approved by the school board after a marathon two-day meeting.
  • New York City will furlough more than 9,000 employees this year to offset pandemic-related budget deficits.
  • At least one coronavirus case had been reported in more than 100 school buildings and early childhood centers in the New York City school system by the first day of in-person instruction on Monday, according to the Department of Education.
  • Missouri Gov. Mike Parson (R) and his wife both tested positive for COVID-19. 
  • 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
  • Here are the most recent editions of the WHO's Weekly Epidemiological Update and Operational Update.
  • U.K. Prime Minister Boris Johnson said Tuesday that Britain has reached a "perilous turning point" in the coronavirus pandemic as he introduced new curfews on pubs and restaurants in England and encouraged remote working — restrictions that could remain in place for six months. 
  • Finland launched a pilot program involving coronavirus-sniffing dogs at Helsinki Airport yesterday, amid hopes that dogs could come to play a key role in screening for the virus. 
  • France raised its COVID-19 alert level in multiple areas across the country and authorities ramped up restrictions on public gatherings in several cities to ease pressure on its health system. The new measures will include the total closure of all bars and restaurants in the cities of Aix-en-Provence and Marseille, and a ban on public gatherings of more than 10 people in Paris and a handful of other French cities. 
  • The regional government of Madrid said yesterday that it will request urgent military and logistics support from the central government to carry out tasks like setting up emergency tents for the homeless and disinfecting public areas. Spain is seeing a spike in cases centered in the capital, parts of which were again put under lockdown this week. 
  • Foreigners with valid residence permits for work, personal matters, and family reunions in China will be allowed to enter the country again without having to apply for new visas starting next week, the Chinese Foreign Ministry said today. Such foreign nationals have been barred since March. 
  • Saudi Arabia said Muslims will be allowed to perform the smaller, year-round pilgrimage starting October 4 as the kingdom gradually begins lifting restrictions that had been in place on Islam’s holiest site for the past seven months due to COVID-19. 
  • About 600 pubs that serve only drinks were allowed to reopen today in Northern Ireland for the first time in six months. 
  • Germany's coronavirus tracing app has been used to transmit 1.2 million test results from labs to users during its first 100 days, according to officials. The Corona-Warn-App, downloaded more than 18 million times since its launch in June, was touted by the government as a key tool in the country's effort to contain the spread of the virus. 
  • Prime Minister Justin Trudeau said yesterday that Canada is in a second wave of COVID-19 and warned that the country is on the brink of a fall season that could be much worse than the spring. 
  • Israeli Prime Minister Benjamin Netanyahu announced plans for a strict, two-week nationwide lockdown in a bid to slow a raging coronavirus outbreak. 
Global Cases 31,926,175 Total Deaths 977,357
 
Lifestyle, Science, and Economy
  • Johnson & Johnson announced plans to enroll 60,000 participants in a Phase 3 trial for their COVID-19 vaccine candidate. The J&J experimental vaccine does not require subzero refrigeration, and it may require one dose rather than two - two big advantages over other vaccine candidates. 
  • An early release in CDC's MMWR shows how difficult it is to successfully implement contact tracing efforts. During a period of high rates of COVID-19 in North Carolina, nearly half of COVID-19 patients reported no contacts, and 25 percent of contacts provided in Mecklenburg County couldn't be reached. In Randolph County, 35 percent of COVID-19 patients reported no contacts, and nearly half of those provided were not reached. Despite aggressive efforts by health departments, many COVID-19 patients do not report contacts, and many contacts cannot be reached. The study suggests that improved timeliness of contact tracing, community engagement, and community-wide mitigation are necessary to reduce coronavirus transmission.
  • Earlier in the pandemic, COVID-19 was thought to be mostly impacting older individuals. However, another MMWR report found that during June–August 2020, COVID-19 incidence was highest in those aged 20–29 years, who accounted for more than 20 percent of all confirmed cases. The authors state that younger adults likely contribute to community transmission of COVID-19. Across the southern U.S. in June 2020, increases in percentage of positive COVID-19 test results among adults aged 20–39 years preceded increases among those over the age of 60 by 4–15 days.
  • A recent study by researchers at the Riken Center for Computational Science, a research institute based in Kobe, Japan, plastic face shields do little to contain the spread of microscopic airborne particles created by such activities as talking, singing, or sneezing. While the face shields can block the spread of some large droplets, the researchers found that they are essentially incapable of capturing droplets five microns or smaller.
  • The Metropolitan Opera announced that it has canceled its entire 2020-21 season and will not reopen until next September. It is the nation’s largest performing arts organization.
  • The 2021 Vienna Opera Ball, one of the most prestigious galas on Austria’s social calendar, is canceled due to COVID-19. 
  • Not sure how to celebrate Halloween safely this year? The CDC has some guidelines to help. 
  • Organizers of the annual New Year's Eve celebration in Times Square said today that this year's event will be mostly virtual. 
  • 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
  • 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.


Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.

Email Marketing Powered by Mailchimp