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
NOTE: During the weekend of Sept. 26-27, a data update on the coronavirus dashboard added nearly 27,000 antigen test results from newly required surveillance testing at long-term care facilities. The update will result in an increase in the number of individual test results and the number of antigen tests currently reported on the website and reported in this newsletter.
Currently, IDPH has reported on the state’s coronavirus dashboard, 86,661 Iowans have tested positive, up 2,501 from our update Friday morning, with a total of 785,124 tested. 13 additional deaths were reported since our last update, bringing the total to 1,316 deaths. Now 66,162 Iowans have recovered. The overall positivity rate is 11.0% and the total 14 day rolling average positivity rate is 9.0%. 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 29.5%
Lyon 25.9%
Osceola 24.7%
Henry 24.2%
Crawford 19.5%
Plymouth 18.1%
Fremont 18.0%
Delaware 16.7%
Sac 16.5%
Dubuque 16.3%
O’Brien 15.9%
Woodbury 15.6%
Palo Alto 15.6%
Winnebago 15.1%
Friday, Governor Reynolds signed a new proclamation continuing the Public Health Disaster Emergency.
The proclamation extends the closure of bars, taverns, wineries, breweries, distilleries, night clubs in Johnson and Story counties for an additional week, until 11:59 p.m. on October 4, 2020. They may continue to sell alcoholic beverages for consumption off premises. Restaurants in these two counties are still permitted to remain open, but must stop selling and serving alcoholic beverages after 10:00 p.m.
Restaurants in Johnson and Story counties, like bars and restaurants in all other counties, must also continue to follow other mitigation measures. This includes the requirements to ensure six feet of physical distance between each group or individual dining or drinking; to ensure all patrons have a seat at a table or bar and consume alcohol or food while seated; and to limit congregating together closer than six feet. The full proclamation is here.
Bars across the state that have been found in non-compliance with COVID-19 mitigation measures are being cited by the Iowa Alcoholic Beverages division and assessed civil penalties. See more here and here.
The Des Moines Public School District, the only one in the state in non-compliance with the State’s in-person return to learn guidelines, cancelled a meeting originally scheduled for today to discuss health metrics and their relation to their Return to Learn work, out of respect for Yom Kippur. The meeting has been changed to Wednesday, September 30 at 5:00 p.m., and will be livestreamed on the DMPS YouTube channel.
Federal Actions
HHS Sec. Alex Azar said Friday he would be "first in line" to get a COVID-19 vaccine.
FDA posted a document summarizing updated evidence to support the emergency use of COVID-19 Convalescent Plasma. The agency will continue to review the circumstances and appropriateness of the authorization for emergency use. To make this information accessible to the public, the document posted on the web presents FDA’s review in relatively plain language.
The FDA re-issued an EUA for the Assure COVID-19 IgG/IgM Rapid Test Device, making it the first authorized serology (antibody) test that can be used at the point of care (POC), meaning it is authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
FDA developed new health education materials that have been culturally and linguistically tailored for diverse consumers. These materials are intended for health care professionals to share with their patients to help stimulate dialogue and answer pressing questions about FDA’s response to COVID-19. The materials provide information on the different areas of the FDA’s response to the pandemic, including health fraud, medical product supply, therapeutics, vaccine development, and diagnostic and antibody testing.
As of Friday, 255 tests are authorized by FDA under EUAs; these include 204 molecular tests, 47 antibody tests, and 4 antigen tests.
Read the CDC's September 25 Science Update here. As a reminder, 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.
Here is last week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
The NIH has reportedly lost an estimated $10 billion in research productivity since the start of the pandemic.
CMS released new tools to reduce burdensome paperwork and authorization delays for laboratories seeking Clinical Laboratory Improvement Amendments (CLIA) certification to test for COVID-19. CMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process implemented at the beginning of the public health emergency that allows labs to start COVID-19 testing before the official paper certificate arrives by postal mail. Laboratories also have a new option to pay CLIA certification fees on the CMS CLIA Program website. Online payments are processed overnight, which is substantially faster than hard-copy checks.
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
Senate Finance Committee Chairman Chuck Grassley (R-IA) released a comprehensive report on care in nursing homes and other long-term care facilities in the United States during the ongoing COVID-19 pandemic. The report, titled “COVID-19 and Nursing Homes: What Went Wrong and Next Steps,” reviews U.S. nursing home performance during the first eight months of the pandemic. Data indicate that more than two out of five deaths due to COVID-19 in the United States are linked to nursing homes and other long-term care facilities.
Energy and Commerce Chairman Frank Pallone (D-NJ), Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) requested the independent Office of Inspector General (OIG) within HHS investigate potential political interference by the White House and Trump Administration political appointees into the scientific work of employees at the CDC responding to the COVID-19 pandemic.
The federal government is expected to start cracking down aggressively on hospitals for not reporting complete COVID-19 data daily into a federal data system. One possible consequence of not reporting data is the withholding of Medicare funding from non-compliant hospitals. The pending update to the reporting guidelines will only require the supply data once a week. However, draft documents show the newest guidelines would add several questions about influenza patients such as the number admitted to the hospital with flu, the number of flu patients in intensive care unit beds and the number of patients confirmed to have both flu and COVID-19.
A member of HHS Sec. Alex Azar's security detail tested positive for COVID-19 last week.
Updates from the States
Out of the cases under investigation detected by U.S. surveillance, there are 7,059,087 total cases and204,033 deathsThe CDC data closes out the day before reporting.
Virginia Gov. Ralph Northam (D) has tested positive for COVID-19.
An ABC News analysis of COVID-19 trends across all 50 U.S. states as well as Washington, D.C. and Puerto Rico found there were increases in newly confirmed cases over the past two weeks in 32 states, the nation's capital and the U.S. island territory in the Caribbean. The analysis also found increases in the daily positivity rate of COVID-19 tests in 21 states, increases in COVID-19 hospitalizations in 17 states and increases in daily COVID-19 death tolls in nine states.
Hawaii Gov. David Ige (D) signed a supplementary emergency proclamation that leaves in place the 14-day mandatory quarantine requirement for out-of-state travelers. However, beginning October 15, a pre-travel testing option will allow travelers an alternative to the mandatory 14-day quarantine.
Gov. Ige also approved the award of $14 million in CARES funding for the Department of Health to provide more than 200 additional nurses and other specialists for hospitals statewide over the next four months. Some of the out-of-state personnel will begin arriving this weekend.
Gov. Ige signed a supplementary emergency proclamation that extends the COVID-19 emergency period through October 31.
New York Gov. Andrew Cuomo (D) announced that New York State will form an independent Clinical Advisory Task Force comprised of leading scientists, doctors, and health experts who will review every COVID-19 vaccine authorized by the federal government, and will advise New York State on the vaccine's safety and effectiveness in fighting the virus.
Connecticut Gov. Ned Lamont (D) announced details for his plans to move Connecticut into Phase 3 of the state’s reopening amid the ongoing COVID-19 pandemic. The plan, which is targeted to take effect on Thursday, October 8, 2020, will ease some of the restrictions that were put into place on businesses and gatherings while ensuring that the state continues taking a safe approach to limit the spread of the virus.
Florida Gov. Ron DeSantis (R) lifted state restrictions for restaurants and many other businesses on Friday as the state moved into the next reopening phase. Restaurants and many other businesses will be allowed to operate at full capacity as part of Phase 3 of his administration’s reopening plan.
Facing a worrying spike in cases in Orthodox Jewish neighborhoods, New York City health officials began carrying out emergency inspections at private religious schools today and threatened to impose an extraordinary lockdown in those communities that would be the first major retreat by the city on reopening since the pandemic began.
Washington Gov. Jay Inslee (D) announced that Washington is setting new requirements for commercial airports and recommendations for airlines. This is a statewide approach to the COVID-19 pandemic to help protect the health and safety of workers, passengers, and crew in the aviation sector.
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
With the world fast approaching one million deaths officially related to COVID-19, a doubling of that number is “certainly unimaginable, but it’s not impossible,” WHO expert Mike Ryan said Saturday.
Sweden, where a shutdown-free pandemic response prompted a global debate, is seeing another wave of COVID-19 cases, with the country’s state epidemiologist warning this week that it was heading in the “wrong direction” as winter approaches.
Because of new crowd size limits handed down by France Prime Minister Jean Castex for Paris and other cities, only 1,000 spectators will be allowed each day at the French Open.
Limits on the number of Australians who can return have spurred a growing uproar over the country’s hardline approach on COVID-19.
In an act of defiance, Syria's union of doctors announced last month that 61 physicians had died of the coronavirus in the span of just a few days. The disclosure contradicted the Syrian government, which had said a day earlier it had registered exactly 60 deaths in the entire country since March, and represented an uncharacteristic challenge to a state known for its tight control of information and severe intolerance for alternative views.
The economic fallout from the pandemic is propelling thousands of Tunisians to make the perilous Mediterranean journey in search of better living conditions, with the largest wave in nearly a decade reaching Italy's shores. The strict lockdown Tunisia imposed in March was largely successful in containing the outbreak, but the measures devastated the country’s already ailing economy.
The WHO warned that more than 80 percent of cases of COVID-19 in Africa could be asymptomatic.
Tokyo 2020 Olympic organizers are proposing to cut the number of officials at next year’s postponed Summer Games by 10-15 percent as part of a wider package of proposals aimed at reducing costs and streamlining the event for a post COVID-19 world.
Russia’s sovereign wealth fund (RDIF) says it has agreed to supply up to 35 million doses of the Sputnik V vaccine to Uzbekistan. RDIF said in a statement that upon approval by Uzbekistan’s regulators, up to 10 million doses of the vaccine will be delivered to Tashkent-based pharmaceutical company Laxisam in 2020. As many as 25 million doses will be shipped in 2021.
South Korea will implement strengthened social distancing measures around the nation’s upcoming Chuseok holidays. Minister of Health Park Neung-hoo said in a briefing that restaurants and cafes with more than 20 seats in the Seoul metropolitan area will have to keep tables at a minimum distance of one meter apart unless dividers are installed. Movie theaters and internet cafes must leave one seat empty between clients.
India reported under 90,000 new cases for the fifth straight day. Based on the current rate of infection, India is expected within weeks to become the pandemic's worst-hit nation, surpassing the U.S.
The U.K. reported 6,634 new cases of COVID-19 yesterday, its highest daily caseload since the start of the pandemic.
A Chinese health official said Friday that the country’s annual production capacity for coronavirus vaccines will top 1 billion doses next year, following an aggressive government support program for construction of new factories. Capacity is expected to reach 610 million doses by the end of this year.
The island kingdom of Bahrain has the highest number of active virus cases per million people in the Arab world, according to a tweet by the American University of Beirut’s Global Health Institute. Lebanon ranks second with 2,628 active cases per million.
Global Cases: 33,130,914 Total Deaths: 998,145
Lifestyle, Science, and Economy
A study of more than 28,500 dialysis patients published Friday in The Lancet found fewer than 10 percent of U.S. adults had coronavirus antibodies as of July — far below what public health experts say is needed to achieve herd immunity.
AstraZeneca is still waiting for the U.S. drug regulator to approve the restart of the clinical trial of its potential COVID-19 vaccine in the U.S. almost three weeks after it was paused due to safety concerns.
Yale University has designated three independent laboratories to perform the university-developed SalivaDirect™ COVID-19 test. Along with Yale Pathology Labs — the first to offer the test — Access Medical Laboratories, Hennepin County Medical Center (HCMC), and Mirimus, Inc., represent the initial wave of providers for the innovative testing method. They will make SalivaDirect™ available to people in Florida, Minnesota and New York by late September.
A standard test that assesses blood cells can identify which patients who are admitted to the hospital with COVID-19 face a high risk of becoming critically ill and dying, according to an article published earlier this week.
Organizers of Rio de Janeiro's Carnival announced Thursday evening that the colorful, rhythmic parades of 2021 are postponed indefinitely due to COVID-19. It's the first time Carnival has been postponed in more than a century.
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.
Join a Facebook Live Q&A on reopening schools and workplaces with Joseph Allen, Director of the Healthy Buildings Program, Harvard T.H. Chan School of Public Health on Tuesday, September 22 at 12 PM.
In the latest kid-friendly pandemic video published by BrainPOP, the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, explains to students of all ages the role they can play in controlling the spread of coronavirus.
MMWR Weekly COVID-19 Briefing is a weekly podcast to update readers on the latest scientific information from CDC’s COVID-19 response. In each episode, MMWR’s Editor-in-Chief, Dr. Charlotte Kent provides an overview of the latest scientific information published in MMWR. New episodes are posted every Monday. Listen to episodes here.