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, 246,240 Iowans have tested positive, up 1,394 from our update yesterday morning, with a total of 1,255,021 tested. 7 additional deaths were reported since our last update, bringing the total to 2,724 deaths. Now 168,057 Iowans have recovered. The total 14 day rolling average positivity rate is 16.0% the past 7-day average is 12.1%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here. There are currently 1,000 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. School district waiver requests and whether they are granted or denied are listed here.
Currently 67 (of 99) counties are above a 15 percent positivity rate over the past 14 days. Click here to search county data for today.
Federal Legislation Supplemental IV Timeline: After an increasingly pessimistic couple of weeks, last week showed some momentum for passing a COVID relief package before the end of the year. Two proposals were released last week – an updated version of Leader McConnell’s $500 billion package and a framework unveiled by a bipartisan, bicameral group, including the Problem Solvers Caucus. The bipartisan group, calling themselves the “908 coalition”, worked through the weekend, with the aim of dropping text tomorrow or Wednesday. If a COVID deal comes together, it will be combined with the omnibus, so there’s only one vote needed before members fly out. Although the current CR runs out this Friday, Congress is gearing up to pass a one-week CR, extending the deadline to finalize any COVID relief deal to next week.
Process/Politics: Right now, it seems the focus is on taking things out of the Bipartisan Package rather than putting new items in. Liability protection will be the last item negotiated and the text could even be released this week with liability protection bracketed. On Wednesday, Speaker Pelosi and Leader Schumer put out a statement endorsing the bipartisan framework, calling for it to serve as the base for negotiations between the two parties. At this point, it seems Democrats are willing to support the bipartisan group’s product – they have indicated that as long as their main priorities are being addressed in some form, they will support the bill.
Democratic leadership seems to be making the calculus that with vaccine distribution ramping up early next year, there will be immense pressure for additional funding for vaccine distribution, and thus, another COVID bill. A bill early next year would then include items that are left out of the current package. Some Democrats have been calling the current package as a “four-month emergency relief package”, assuming another will be necessary in another four months.
Policy: We saw two packages be released last week – an updated version of Leader McConnell’s $500 billion package and a framework unveiled by a bipartisan, bicameral group. The bipartisan framework clocks in at $908 billion, almost double McConnell’s $500 billion proposal. However, the $908 billion is not all new money – they’re still a plan to repurpose unobligated funds from the Paycheck Protection Program and Treasury funds. Thus, the net cost is lower than the $908 billion touted in the press. Democrats and Republicans may characterize the topline differently, however. Without getting too into the weeds, Democrats may refer to the bill’s gross number ($908 billion) rather than its net number.
Problem Solvers/Bipartisan Framework: Last Tuesday, a bipartisan, bicameral group released a COVID package framework. Press release here. Framework here and below.
$160 billion for state, local, and tribal governments
$180 billion for Unemployment Insurance (UI)
$288 billion for the Paycheck Protection Program (PPP), including support for restaurants and live events, and tax deductibility
$12 billion for CDFI/MDIs
$45 billion for airlines/airports, transit, Amtrak
$16 billion for vaccine development/distribution and testing/tracing
$35 billion for the Healthcare Provider Relief Fund
$82 billion for education
$4 billion for student loans
$25 billion for rental housing assistance
$26 billion for nutrition/agriculture
$10 billion for U.S. Postal Service
$10 billion for child care
$10 billion for broadband
$5 billion for opioid funding
Short-term liability protection
Updated McConnell Plan: Last Tuesday, Leader McConnell released an updated version of the $500 billion COVID package he released earlier this fall. Summary here.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (7): Sen. Kelly Loeffler (R-GA), Rep. Brian Steil (R-WI), Rep. Joe Courtney (D-CT), Rep. Susie Lee (D-NV), Rep. Austin Scott (R-GA), Rep. Ted Budd (R-NC), Rep. Robert Aderholt (R-AL)
Currently Self-Quarantined (0):
Recovered (24): Sen. Rand Paul (R-KY), Rep. Joe Cunningham (D-SC), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL), Rep. Mike Kelly (R-PA), Rep. Nydia Velazquez (D-NY), Rep. Neal Dunn (R-FL), Rep. Tom Rice (R-SC), Rep. Morgan Griffith (R-VA), Rep. Louie Gohmert (R-TX), Rep. Raúl Grijalva (D-AZ), Rep. Rodney Davis (R-IL), Sen. Bill Cassidy (R-LA), Rep. Jenniffer Gonzalez-Colon (R-Puerto Rico at large), Rep. Dan Meuser (R-PA), Rep. Jahana Hayes (D-CT), Sen. Mike Lee (R-UT), Sen. Thom Tillis (R-NC), Sen. Ron Johnson (R-WI), Rep. Salud Carbajal (D-CA), Rep. Mike Bost (R-IL), Rep. Bill Huizenga (R-MI), Rep. Drew Ferguson (R-GA), Rep. Don Young (R-AK), Sen. Rick Scott (R-FL), Rep. Tim Walberg (R-MI), Rep. Cheri Bustos (D-IL), Sen. Chuck Grassley (R-IA), Rep. Ed Perlmutter (D-CO), Rep. Dan Newhouse (R-WA), Rep. Doug Lamborn (R-CO)
Completed Quarantine (48): Sen. Ted Cruz (R-TX), Rep. Mark Meadows (R-NC)*, Sen. Lindsay Graham (R-SC), Rep. Don Beyer (D-VA), Rep. Sharice Davids (D-KS), Rep. Doug Collins (R-GA), Rep. Paul Gosar (R-AZ), Sen. Cory Gardner (R-CO), Sen. Rick Scott (R-FL), Rep. Matt Gaetz (R-FL), Rep. Jason Crow (D-CO), Rep. Julia Brownley (D-CA), Rep. Ben Ray Luján (D-NM), Rep. Gwen Moore (D-WI), Rep. Stephanie Murphy (D-FL), Rep. John Yarmuth (D-KY), Rep. Adam Schiff (D-CA), Rep. Vincente Gonzalez (D-TX), Rep. Drew Ferguson (R-GA), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Ann Wagner (R-MO), Rep. Kathleen Rice (D-NY), Rep. Matt Cartwright (D-PA), Rep. Tom Cole (R-OK), Rep. Steve Scalise (R-LA), Rep. Frederica Wilson (D-FL), Rep. Andy Kim (D-NJ), Rep. Kendra Horn (D-OK), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT), Rep. Katie Porter (D-CA), Rep. Seth Moulton (D-MA), Rep. Lizzie Fletcher (D-TX), Rep. Josh Gottheimer (D-NJ), Rep. Ayanna Pressley (D-MA), Rep. Mikie Sherrill (D-NJ), Sen. Lamar Alexander (R-TN), Rep. Randy Weber (R-TX), Rep. Kay Granger (R-TX), Rep. Mike Johnson (R-LA), Rep. Jody Hice (R-GA), Rep. Guy Reschenthaler (R-PA), Sen. Ron Johnson (R-WI), Sen. Shelley Moore Capito (R-WV), Rep. Lisa Blunt Rochester (D-DE), Sen. Ben Sasse (R-NE), Sen. James Lankford (R-OK), Sen. Ted Cruz (R-TX), Rep. Mike Johnson (R-LA), Sen. Kamala Harris (D-CA), Rep. Mark Pocan (D-WI
Other Federal Actions
An NIH-funded tool can now help organizations choose a COVID-19 testing strategy that will work best for their specific needs. The COVID-19 Testing Impact Calculator is a free resource that shows how different approaches to testing and other mitigation measures, such as mask use, can curb the spread of the virus in any organization. It is the first online tool in the nation to provide schools and businesses with clear guidance on risk-reducing behaviors and testing to help them stay open safely.
The NIH recently updated their COVID-19 treatment guidance. The guidelines narrowed the scope of recommended use for remdesivir (Veklury) in hospitalized COVID-19 patients.
The White House is set to host a “COVID-19 Vaccine Summit” today for vaccine manufacturers, drug distributors, and government officials. Pfizer and Moderna have reportedly declined the invitation to attend.
VRBPAC will meet in open session on Dec. 10 to discuss EUA of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. You can tune in here starting at 9 AM. The group will meet again on Dec. 17 to discuss the Moderna vaccine.
Here is the most recent 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 CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on their dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
FDA Commissioner Stephen Hahn delivered remarks to the FDA-CMS summit which you can see here.
Late last week, the FDA authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.
The FDA has added content to the question-and-answer appendix in its guidance titled, “Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency.” The updated guidance includes a new question and answer regarding considerations for disposing unused investigational drug product when a study participant cannot return it to the study site. The guidance addresses considerations for using alternative procedures for the disposition of the investigational product provided that such procedures do not expose humans to risks from the drug.
PrecisionFDA has launched the COVID-19 Precision Immunology App-a-thon. The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors. The challenge is open now through January 29, 2021.
The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The remaining Town Halls will take place:
Dec. 9, 12:15 PM
Dec. 16, 12:15 PM
HHS announced it will distribute $523 million in second round performance payments to over 9,000 nursing homes. These nursing homes are being rewarded for successfully reducing COVID-19 related infections and deaths between September and October. The announcement is the second of five evaluation cycles rewarding nursing homes for their performance reducing nursing home infection and mortality rates. Nursing homes will begin receiving payments December 9.
Education Sec. Betsy DeVos announced Friday that pandemic relief for about 41 million federal student loan borrowers will continue until Jan. 31.
President Trump is expected to sign an EO tomorrow to state that U.S. efforts to assist other countries in vaccinating their populations against COVID-19 will be a lower priority than domestic inoculations.
The Office of Refugee Resettlement within HHS said there have been 1,061 lab-confirmed COVID-19 cases among unaccompanied migrant children in their care.
Rep. Robert Aderholt (R-AL) is the most recent Member of Congress to test positive for COVID-19.
Liability protection seems to be the last piece holding up an additional COVID-19 supplemental funding package in Congress. For more detail on the legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update.
Updates from the States
Out of the cases under investigation detected by U.S. surveillance, there are 14,636,914 total casesand 281,253 deaths.The CDC data closes out the day before reporting.
For the first time since the start of the pandemic, the U.S. is reporting an average of nearly 2,200 COVID-19 deaths per day. The national seven-day average of COVID-19 deaths per day is currently 2,171. That figure has increased by 139 percent in the past month.
The U.S. has reported over 100,000 new cases of COVID-19 every day for more than a month straight.
Hospitalizations continue to surge to unprecedented levels, with over 101,000 patients currently hospitalized with COVID-19 across the country – a new national record. In the past two months, hospitalizations have more than tripled.
Officials have reported that the number of people hospitalized in Nevada with COVID-19 has more than doubled over the last month.
On Monday afternoon, Massachusetts Gov. Charlie Baker (R) announced that hospitals in his state will stop offering elective surgeries that can be safely postponed beginning Friday in order to free up necessary staffing and beds.
The Navajo Nation begins a three-week emergency lockdown on Monday, during which residents are required to remain at home 24 hours a day, seven days a week. Essential businesses, including grocery stores, gas stations, laundromats, and restaurants providing drive-thru or curbside service, may remain open on weekdays between 7 AM and 7 PM. Off-reservation travel is not permitted, and, on weekends, a full lockdown will be in place. The lockdown rules will remain in effect until Dec. 28.
New York Gov. Andrew Cuomo (D) on Monday announced new criteria for rolling back the state’s reopening and reintroducing shutdown restrictions by region. Under the new plan, the state health department will use hospitalization rates as thresholds for shutdowns and restricting indoor dining, which the governor said could be barred in New York City as soon as Monday.
Gov. Cuomo also announced his state is partnering with Prescryptive Health to expand COVID-19 testing capacity. The partnership will help increase testing capacity in areas where testing access is limited, offering 150 new rapid testing locations statewide.
New York City began reopening public schools yesterday because of the determined public health benefits of keeping schools operating, particularly for young students, and the real-world experience of over two months of in-person classes in the city’s school system.
Michigan Gov. Gretchen Whitmer (D) said on Monday that her administration would extend the closures of high schools, universities, and businesses such as casinos and movie theaters for 12 days, as well as a shutdown of indoor dining and organized sports, as officials monitor the number of available hospital beds across the state.
Wyoming Gov. Mark Gordon (R) announced a new statewide indoor face mask order and new restrictions on social gatherings and businesses. Gatherings without required distancing are limited to 10 people; bars and restaurants must close at 10 PM; patrons seated at bars, restaurants, theaters, concert halls, and large events will be limited to groups of 6; and group workout classes at gyms are limited to 10 people.
Delaware Gov. John Carney (D) announced a new stay-at-home advisory, strongly advising all Delawareans to avoid gathering indoors with anyone outside of their household from Dec. 14 through Jan. 11. Gov. Carney will also institute a mask mandate statewide, requiring people to wear a face covering any time they are indoors with someone outside of their immediate household.
Ohio Gov. Mike DeWine (R) said on Monday that he will extend the state’s current curfew order. Infections and hospitalizations across the state continue to rise at a rapid pace. As a result, the Cleveland Clinic and several other hospitals have postponed elective surgeries that require an overnight stay.
The Arizona legislature has closed after former New York City Mayor Rudy Giuliani, who tested positive for COVID-19 over the weekend, spent two days with maskless GOP lawmakers. Public health officials in Michigan have ordered several state lawmakers to begin quarantining on Monday, after they were also in recent, close contact with Mr. Giuliani. Georgia state senators who attended a seven-hour hearing last week with him were similarly urged to self-quarantine.
School districts across the country are adjusting their education plans. New York City is reopening some of its public schools Monday despite a worsening coronavirus outbreak. The Los Angeles public school district, the second-largest in the U.S., will revert to online learning for the rest of the semester. Three other large districts — in Birmingham, Alabama, Tulsa, Oklahoma, and Wichita, Kansas — closed over the past week.
Colorado Gov. Jared Polis (D) extended an EO that expands the health care workforce for hospitals and other inpatient treatment facilities.
Illinois Gov. JB Pritzker (D) announced that the state’s department of health and human services will launch an outreach campaign to Latinx and immigrant communities facing disproportionately high COVID-19 positivity rates. The campaign, which communicates in Spanish and 16 other languages, aims to empower community members to protect their own health and that of their family members.
Connecticut, Hawaii, Louisiana, and Nevada announced that requests to extend the federal authorization of their state National Guard’s support to ongoing state responses to the COVID-19 public health emergency have been approved. The federal government will provide the states with a 75 percent cost-share for this period.
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. NPR's map can also be used to monitor your state's heat wave.
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.
BIO announced that yesterday a new educational website, COVID Vaccine Facts. The goal of the website is to address frequent questions about COVID-19 vaccines and vaccine development, with a specific focus on educating both providers and the general public in the U.S.
An MMWR early release outlines how Head Start and Early Head Start programs successfully implemented CDC-recommended guidance and other ancillary measures for child care programs that remained open, allowing them to continue offering in-person learning. These approaches were documented to guide implementation of mitigation strategies in child care settings.
Another MMWR report has summarized guidance for public health strategies to mitigate community spread, including the “consistent and correct” use of face masks indoors.
The D.C. government has released a new set of COVID-19 data — the first to arrange clusters of cases by setting — that shows restaurants and bars are among the most common environments where the virus spreads.
Elementary school students who were learning remotely in the spring lost the equivalent of roughly three months’ progress in math and fell a month and a half behind in reading, according to a new analysis released by McKinsey & Company.
Colleges and universities across the country are announcing decisions to host more students for the Spring semester than in the Fall as they say they have learned strategies to minimize risk.
A new report from One Fair Wage found that more than 80 percent of service industry workers are seeing a decline in tips and over 40 percent say they're facing an increase in sexual harassment from customers. Of those, around 60 percent said they were reluctant about enforcing social distancing and mask use with customers from whom they would receive tips. The title of the report, "Take Off Your Mask So I Know How Much to Tip You," is a reference to one of several disturbing comments women workers say they've been hearing from patrons.
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 the most recent edition of the WHO's Weekly Epidemiological Update and here is the most recent edition of the WHO's Weekly Operational Update.
An army of health care workers — assisted by tens of thousands of volunteers and the military — will begin rolling out doses of a COVID-19 vaccine in Britain on Tuesday morning, aiming to vaccinate more than 20 million citizens in just a few months.
The E.U.’s drug regulator is expected to make a decision on approving the first COVID-19 vaccine for use by Dec. 29.
Russia began its national vaccination campaign over the weekend. Even though the vaccine, Sputnik V, has yet to be proven fully safe and effective, health care workers have started to inoculate thousands of people.
Canadian prime minister Justin Trudeau said yesterday that the first doses of the Pfizer coronavirus vaccine will arrive in his country next week at 14 distribution centers. The vaccination process won’t start until the country’s national regulator approves the vaccine. Mr. Trudeau said that Pfizer will send 249,000 doses of the six million Canada has purchased by the end of December.
U.S. sanctions have prevented Iran from paying for and accessing COVID-19 vaccines, Iran’s Central Bank governor said Monday. Iran is participating in the global COVAX plan sponsored by the WHO that seeks equitable distribution of COVID-19 vaccines worldwide.
A Chinese coronavirus vaccine manufacturer, Sinovac Biotech, secured $515 million in funding to double production capacity of its coronavirus vaccine as it begins supplying the vaccine to nations like Indonesia.
French health authorities said on Monday that a decline in the number of new COVID-19 infections and hospitalizations in the country was still far short of the drop necessary to further ease lockdown rules.
As a deadly wave of COVID-19 cases extends across Europe, several countries are planning to loosen restrictions over the holidays to allow families and friends to gather.
In a four-day period beginning Dec. 23, people across Britain can form a Christmas bubble, which will allow members of up to three households to spend time together in private homes or to attend places of worship.
In Germany, officials have agreed to extend a partial lockdown to Jan. 10, but loosen restrictions from Dec. 23 to Jan. 1, allowing private gatherings of as many as 10 people from any number of households.
Spanish officials have decided to allow travel between regions to see relatives and close friends but said that social gatherings around Christmas and New Year’s Day must be limited to 10 people if not from the same household.
In France, residents will be under a nationwide curfew from 9 PM to 7 AM beginning Dec. 15, when a national lockdown ends. However, the curfew will not apply from Christmas Eve to New Year’s Eve.
Greece is extending its lockdown until Jan. 7, with schools, courts, bars, restaurants, gymnasiums, and ski resorts remaining closed. Travel between regions will remain prohibited, and a nighttime curfew will also stay in place.
On Monday, Denmark expanded lockdown measures until Jan. 3 in 38 of its 98 municipalities, including Copenhagen, officials said. Beginning Dec. 9, restaurants, museums, movie theaters, and other similar cultural establishments must close. Select grade school students and students at universities will be sent home.
COVID-19 cases are surging in South Korea, which recovered from an initial wave of cases in the spring and then managed to keep new infections low for several months. Case numbers are reaching their highest point in nine months, with 615 cases reported Sunday. President Moon Jae-in has ordered more intensive contact tracing and testing efforts, including longer hours for testing sites to accommodate a growing number of patients.
Hong Kong has installed vending machines for COVID-19 test kits in 10 subway stations. The regional government said it will be supplying about 10,000 self-administered test kits to the mass transit authority for distribution to the vending machines daily.
Israeli Prime Minister Benjamin Netanyahu’s office has announced plans for a nighttime curfew during the upcoming Hanukkah holiday. The curfew is set to go into effect on Wednesday, on the eve of Hanukkah. Commercial activities will be banned, and inter-city travel will be limited.
South African Health Minister Zweli Mkhize has called on students who attended end-of-year parties to immediately self-quarantine for 10 days.
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.