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.
Currently, IDPH has reported on the state’s coronavirus dashboard, 71,891 Iowans have tested positive, up 873 from our update yesterday morning, with a total of 683,201 tested. Antigen test results are now included in the overall data and broken out separately from PCR test results in the data here. 19 additional deaths were reported since our last update, bringing the total to 1,204 deaths. Now 55,621 Iowans have recovered. The overall positivity rate is 10.5% and the total 14 day rolling average positivity rate is 9.6%. 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 8 counties are above 15 percent positivity rate over the past 14 days:
Yesterday, HHS and the Assistant Secretary for Health issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they are made available. This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.
The Indian Health Service (IHS) announced the formation of a COVID-19 Critical Care Response Team to provide deployable resources to augment urgent lifesaving medical care to COVID-19 patients admitted to IHS or tribal hospital emergency department or inpatient settings. The addition of expert critical care support assists IHS hospitals in managing the surge in critically ill patients resulting from the pandemic and provides what IHS has deemed the most vulnerable patients the greatest chance of survival. In the event of an urgent need, the CCRT can rapidly mobilize, usually as soon as within 24-48 hours of the decision to deploy the team.
The FDA has deactivated the FDA registration for 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. Of these, 131 establishments list devices that are essential to the COVID-19 pandemic response.
As of today, 244 tests are authorized by FDA under EUAs; these include 196 molecular tests, 44 antibody tests, and 4 antigen tests.
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 16, 12:15 PM
September 23, 12:15 PM
September 30, 12:15 PM
The CDC announced yesterday that, starting September 14, the U.S. government will remove requirements for directing all flights carrying airline passengers arriving from, or recently had a presence in, certain countries to land at one of 15 designated airports and halt enhanced entry health screening for these passengers. Currently, enhanced entry health screening is conducted for those arriving from, or with recent presence in, China (excluding the Special Administrative Regions of Hong Kong and Macau), Iran, the Schengen region of Europe, the U.K. (excluding overseas territories outside of Europe), Ireland, and Brazil.
A recent CDC email outlined what the agency has done to monitor cases of multisystem inflammatory syndrome in children (MIS-C). CDC has a dedicated team investigating MIS-C to learn more about this syndrome and communicate information quickly to healthcare providers, parents and caregivers, as well as state, local and territorial health departments. The team is working with U.S. and international scientists, healthcare providers, and other partners to learn more about this new syndrome. They are learning about how often it happens and who is likely to get it, creating a system to track cases, and providing guidance to parents and healthcare providers. Since mid-May, the CDC has been tracking reports of MIS-C. Many questions remain about why some children develop it after a COVID-19 illness or contact with someone with COVID-19, while others do not. As of September 3, CDC has received reports of 792 confirmed cases of MIS-C and 16 deaths in 42 states, New York City, and Washington, D.C. Additional cases are under investigation.
The CDC continues to update online resources and guidance documents. Check the list of most recent updates here.
The HHS Assistant Secretary for Preparedness and Response recently published Discharge Planning and Care Coordination during the COVID-19 Pandemic, a resource developed in partnership with ACL and the Centers for Medicare & Medicaid Services. The tool is designed to support nurses, social workers, case managers, and others conducting discharge planning for adults with disabilities after COVID-19 treatment.
The Senate HELP Committee met yesterday for a hearing titled, "Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health." NIH Director Francis Collins and U.S. Surgeon General Jerome Adams testified.
Oversight and Reform Committee Chairwoman Carolyn Maloney (D-NY), Select Subcommittee on the Coronavirus Crisis Chairman Jim Clyburn (D-SC), and Subcommittee on Economic and Consumer Policy Chairman Raja Krishnamoorthi (D-IL) sent a letter to HHS requesting written responses and a staff briefing on the federal government’s plans to deploy a coronavirus vaccine after licensure or authorization. The Chairs asked about preparations for distribution, plans to prioritize the vaccine for at-risk populations, efforts to ensure public transparency and increase vaccine confidence, and safeguards to ensure decisions are made free from political considerations.
The Senate will vote on a "skinny" stimulus package today. Majority Leader Mitch McConnell is hoping for 51 votes in favor of the bill, not the 60 that would be required for cloture. Bill text is here. Bill summary is here.
Updates from the States
Out of the cases under investigation detected by U.S. surveillance, there are 6,310,663 total cases and189,147 deathsThe CDC data closes out the day before reporting. Other entities are now reporting over 190,000 deaths in the U.S.
Iowa and South Dakota seem to have emerged as the new hotspots in the U.S.
Colorado Gov. Jared Polis (D) extended the disaster declaration and employment of the Colorado National Guard to support and provide planning resources to state and local authorities responding to COVID-19.
Maine Gov. Janet Mills (D) extended the State of Civil Emergency through October 1, 2020.
Hawaii Gov. David Ige (D) approved another two-week extension of the “State-at-Home, Work-at-Home” order for the City and County of Honolulu, which will now end September 24.
Kentucky Gov. Andy Beshear (D) extended the commonwealth’s mandate for face coverings in some situations for another 30 days.
New York Gov. Andrew Cuomo (D) said indoor dining in New York City will return with limits on September 30.
Arizona reported its lowest number of new cases since late March.
For the first time in almost six months, Navajo Nation authorities reported no new cases of COVID-19.
The Los Angeles County Department of Public Health banned haunted house attractions and said door-to-door trick-or-treating is not recommended.
A group of gym and boutique fitness studio owners announced a class-action lawsuit on Wednesday against Mayor Bill de Blasio and New York City to allow indoor group fitness classes to reopen in the city. While gyms in New York were allowed to open back in August, indoor boutique studios and group classes, like Pilates, Zumba, and yoga have remained banned.
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.
Germany has extended its travel advisory to include all countries outside Europe through September 30. The foreign ministry said it will start to evaluate individual non-European destinations case by case, rather than issue another blanket warning, starting next month.
China’s top leader, Xi Jinping, said yesterday that the country’s success in suppressing its coronavirus outbreak was a vindication of Communist Party rule.
Prime Minister Boris Johnson announced that Britain will implement a ban on gatherings of more than six people starting next week in response to a recent spike in COVID-19 cases.
French prime minister Jean Castex is self-isolating after he came into contact with the director of the Tour de France, who has tested positive. Mr. Castex tested negative on Tuesday, but he will isolate until being retested seven days after the contact took place.
Japan approved a plan to spend more than $6 billion from its emergency budget reserves on coronavirus vaccines.
India surpassed Brazil to become the country with the second-highest number of COVID-19 cases in the world behind the U.S.
On Tuesday, India's Health Ministry announced plans to open classrooms for high school students on a voluntary basis, and only with their parents’ approval, starting September 21. The vast majority of schoolchildren will continue to study online.
The Taj Mahal will also open for tourism on September 21, with access restricted to 5,000 people per day.
China’s biggest air show is scheduled to go ahead as planned in November, which is a backtracking of an earlier announcement that the event had been canceled because of the pandemic.
Amid rapidly surging new virus cases each day, Turkey is requiring masks be worn in all public places, including offices, factories, and open-air places such as parks and beaches.
The U.N. confirmed the first known cases of COVID-19 among Syrian refugees in a camp in Jordan that houses around 40,000 people who fled fighting in Syria.
The U.S. Agency for International Development (USAID), which has been on the front lines of the battle with COVID-19, decided to pull funding and shut down its coronavirus pandemic task force.
Hong Kong will expand the size of legal public gatherings to four from two on Friday, as the Chinese territory loosens restrictions that it imposed this summer to fight a third wave of infections. More sports and entertainment venues will also be allowed to reopen.
A UNICEF survey conducted over the summer across 77 countries found that almost 68 percent of countries reported at least some disruption in health checks for children and immunization services because of the pandemic. In addition, 63 percent of countries reported disruptions in antenatal checkups and 59 percent in post-natal care.
Global Cases: 27,897,904 Total Deaths: 904,364
Lifestyle, Science, and Economy
The AstraZeneca vaccine trial has been put on a clinical hold an individual enrolled in a Phase II/III trial had experienced a rare form of spinal cord inflammation. During the trial suspension, an independent board of experts will determine if the inflammation was a result of the vaccine or if it was a separate issue. The halt has two effects- it concerns those in the trial for the time being, and it shows why OWS has selected six vaccinates, so there is less pressure if one of the six doesn't work.
According to the American Academy of Pediatrics and the Children's Hospital Association, half a million children in the U.S. have been diagnosed with COVID-19. The groups said 70,630 new child cases were reported from August 20 through September 3, representing a 16 percent increase in child cases over two weeks, and bringing up the total to at least 513,415 cases.
For a variety of reasons, many testing sites across the country do not test any children. This hampers schools’ ability to quickly isolate and trace coronavirus cases among students. It could also create a new burden on working parents, with some schools and child care centers requiring symptomatic children to prove a negative COVID-19 test before rejoining class.
Findings from a recent publication indicate that more than a quarter of American adults are experiencing COVID-related symptoms of depression. Financial pressures as a result of the pandemic are thought to be the main factor for the rise. Experiencing more COVID-related stressors was a major predictor of depression symptoms.
Racial disparities among essential workers could be a key reason that Black Americans are more likely than whites to contract and die of COVID-19, according to researchers at the University of Utah. They found that Black individuals disproportionately worked in nine vital occupations that increase their exposure to COVID-19.
A new paper from San Diego State University is linking an estimated 250,000 infections from August 2 to September 2 (the equivalent of roughly one-fifth of newly reported cases in the U.S. in that time) back to the Sturgis motorcycle rally in South Dakota.
In an effort to bolster public trust in a vaccine amid President Trump's promise of a vaccine by election day, the chief executives of nine drug companies published a statement pledging not to seek regulatory approval before the safety and efficacy of their experimental coronavirus vaccines have been established in Phase 3 clinical trials.
Scientist David Montefiori has studied how the SARS-CoV-2 virus might mutate as it passed from person to person. Montefiori, a virologist who has spent much of his career studying how chance mutations in HIV help it to evade the immune system, says that SARS-CoV-2 is changing much more slowly than HIV. But one mutation in the gene that encodes the spike protein, which helps virus particles to penetrate cells, appears repeatedly in samples from people with COVID-19.
The results of a new study indicate that the COVID-19-causing virus sometimes attacks the brain, leading to neurological symptoms like headaches, confusion, or delirium.
A series of recent polls show how hesitant Americans are to get a COVID-19 vaccine. Polling over the summer shows that up to a third of Americans will refuse to be vaccinated for COVID-19, much of that an aversion to this particular treatment rather than vaccines in general. Two-thirds of U.S. voters said in another poll that they won't try to get a vaccine as soon as it becomes available (even if it is free), and one in four say they don't want to ever get it.
The results of a survey that examines how COVID-19 has affected households in some of the nation’s largest cities were published this morning and suggest that at least half of households studied in four major U.S. cities reported serious financial problems triggered by the pandemic, and more than half report serious problems caring for their children. The poll, released by NPR, the Robert Wood Johnson Foundation, and Harvard’s T.H. Chan School of Public Health, found that the effects described in New York City, Los Angeles, Chicago, and Houston are falling heaviest on households with annual incomes below $100,000 and in Black and Latino families.
LabCorp announced plans to launch a new at-home COVID-19 diagnostic that allows people to also get tested for the flu and respiratory syncytial virus (RSV) from a single sample.
German genetic testing company Qiagen announced yesterday that it plans to launch a new antigen test that it says could eventually be deployed in airports and stadiums if it receives the appropriate authorizations. The company said it plans to launch two versions of the antigen test in the U.S. later this year: one version that’s meant to be processed in a clinical laboratory and another that’s portable and can be processed at point of care. The company has not yet applied for an EUA from the FDA, but said it plans to do so.
A dentist in Manhattan says that she has seen more tooth fractures in the past six weeks than in the past six years. She sees three factors at work: virus-induced stress that leads to clenching and grinding teeth; poor posture from working at home that can lead to teeth-grinding; and not getting enough rest, which can lead to tension and clenching the teeth.
The stock market bounced back from a three-day sell-off that cut 10 percent off the Nasdaq composite index and pummeled companies that had largely been resilient during the pandemic.
BIO’s pipeline tracker for COVID-19 vaccines, treatments and antivirals is here.
The Johns Hopkins Center for Health Security has an extensive list of commercial and lab-developed tests.
Continue to look at the NIH Office of Portfolio Analysis’s (OPA) expert-curated portfolio of COVID-19 publications and preprints. The portfolio 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.
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.
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.