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COVID-19 Update
December 11, 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.

COVID-19 Vaccine Update

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced yesterday evening that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision. The vaccine could be greenlighted within days by the FDA.

VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published today in The New England Journal of Medicine. The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety. The FDA will take the advisory committee’s recommendation into consideration when it makes a final determination.

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic.”

“I would like to thank the FDA’s advisory committee for recognizing the critical role that our vaccine may play in helping to address this ongoing pandemic. Today’s positive discussion and vote reinforces the potential of our COVID-19 vaccine candidate in helping to protect people against this deadly and devastating disease,” said Ugur Sahin, CEO and Co-founder of BioNTech.
 
FDA Advisory Committees provide non-binding recommendations, with the final decision on approval or authorization to be made by the FDA. Under an EUA, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives.

About the Phase 2/3 Study
The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina.

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints are prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 17 years of age will be gathered in the months ahead. Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201210006182/en/

Governor Reynolds released the following statement on FDA emergency approval of the Pfizer vaccine:   
 
“The FDA approval for the Pfizer vaccine is great news for the state of Iowa and the entire country, and will allow us to move forward in our recovery from COVID-19 with even greater certainty.  Because of our proactive planning, our state is ready to receive shipments and quickly distribute them so that our health care workforce and long-term care residents will be vaccinated first.   
 
“While this is a positive step forward, it will take time until the vaccine is widely available. Until then, we must continue to mitigate the virus by practicing public health measures so we can protect the most vulnerable and preserve hospital resources, while keeping our economy open and our kids in school.”  
 
Iowa Update

Currently, IDPH has reported on the state’s coronavirus dashboard, 253,067 Iowans have tested positive, up 2,040 from our update yesterday morning, with a total of 1,273,644 tested. 99 additional deaths were reported since our last update, bringing the total to 3,120 deaths. Now 183,212 Iowans have recovered. The total 14 day rolling average positivity rate is 15.8% the past 7-day average is 11.3%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here. There are currently 833 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 66 (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/Process/Politics: The current discussions are the farthest we’ve gotten toward a bipartisan bill, and it seems that there is a significant amount of political will from members from both sides of the aisle to get a COVID relief package passed before Congress leaves town. However, time is running out – it’s unclear if negotiators will be able to reach a deal on liability protection in the time left. Once a deal is agreed upon, it will take time to draft the bill and finalize the text. As of publishing, the Senate had yet to pass the one-week continuing resolution that would extend funding for the government until December 18.
 
After a brief interlude on Tuesday, after the White House dropped a $916 billion package with unemployment insurance numbers Speaker Pelosi and Leader Schumer called “unacceptable”, the bipartisan group has continued working towards a deal. While we have yet to see text, the group released an updated framework on Tuesday with more details on various sections of the bill. Later that day, the bipartisan group announced a deal on funding for state, local, and tribal governments, leaving liability protections as the last piece to be negotiated. Soon after that announcement, McConnell’s staff notified congressional leaders that the bipartisan group’s attempts to find a deal on aid to state, local, and tribal governments and liability protections would likely not be enough to placate Senate Republicans. Leader McConnell has continued suggesting lawmakers leave out the two most contentious issues areas – liability protections and funding for state, local, and tribal governments – in favor of including those issues in a later bill. Democratic leadership has continued to dismiss that idea and encourage bipartisan discussions to continue.
 
Policy: The bipartisan group introduced more details on their framework earlier this week and should be seen as the primary base for any deal that surfaces in the next week. The White House and Leader McConnell have both proposed alternative packages to the framework, but both have been rejected by Democratic leadership. It should be noted that the current bipartisan framework is a framework, and not bill text. Once a deal is agreed upon, the chairs of the authorizing committees will need time to write the bill and finalize details.
 
Problem Solvers/Bipartisan Framework: Last Tuesday, a bipartisan, bicameral group released a COVID package framework. December 9 framework. December 1 press release here. December 1 framework here and below.
  • $160 billion for state, local, and tribal governments
  • $180 billion for Unemployment Insurance (UI), $300/week for 16 weeks (through April 2021)
  • $300 billion for the SBA, $288 for Paycheck Protection Program (PPP), including support for restaurants, types of 501(c)(6)s, and live events, tax deductibility, and set-asides for small borrowers and CDFIs/MDIs
  • $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 and mental health funding 
  • Short-term liability protection
White House Proposal: On Tuesday, Secretary Mnuchin presented a $116 billion proposal to Speaker Pelosi and Leader Schumer. Secretary Mnuchin statement here. Proposal reportedly included $600 stimulus checks, but significantly lower levels for unemployment insurance compared to the bipartisan group’s framework.
 
Updated McConnell Plan: On December 1, Leader McConnell released an updated version of the $500 billion COVID package he released earlier this fall. Summary here.
 
Passed Legislation
 New Implementation Information and Guidance
  • 12/9 – CRS released a report on Pandemic-Related Statutory Provisions Expiring in 2020. Report here.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (11): 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), Sen. Kelly Loeffler (R-GA), Rep. Brian Steil (R-WI), Rep. Joe Courtney (D-CT)
Currently Self-Quarantined (1): Rep. Mark Pocan (D-WI)
Recovered (16): 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) 
Completed Quarantine (47): 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)

Other Federal Actions
  • The FDA’s VRBPAC, made up of independent scientific and public health experts from around the country, met to discuss the first request for EUA for Pfizer's COVID-19 vaccine. The panel ultimately voted 17 to 4 in favor of the vaccine, with one member abstaining. The FDA’s top vaccine official, Peter Marks, has said that the agency could greenlight the vaccine within days, after the internal review concluded that the shot showed “a favorable safety profile, with no specific safety concerns.”
  • As a reminder, the Advisory Committee on Immunization Practices (ACIP) at CDC met last week to vote on the phased allocation of COVID-19 vaccines and who will be the first to receive vaccines. The group voted in favor of vaccination in Phase 1a being be offered to both health care personnel and residents of long-term care facilities. Slides are available here. MMWR's summary of the interim allocation recommendations is here. CDC Director Robert Redfield has accepted these recommendations. 
    • Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. 
    • Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently. 
  • The FDA issued an EUA to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test. The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer (non-prescription) test system, allowing a person to self-collect a nasal sample in their home and then send the sample to LabCorp for testing. It can be used by anyone aged 18 or over, and purchased online or in a store without a prescription.
  • The Congressional Research Service released a report on COVID-19 and domestic PPE production and distribution. The report specifically examines the domestic supply, federal actions to increase PPE availability, and policy options concerning PPE production and distribution.
  • The most recent NIH Director's Blog highlights a study from England of thousands of health care workers. Those who got COVID-19 and produced antibodies against the virus were very unlikely to become infected again, at least over the several months that the study was conducted.
  • HHS released new hospital COVID-19 capacity data at the facility level. Previously released data about hospital capacity that had been released was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a "week at a time" picture to protect patient privacy, while providing a view of how COVID-19 is impacting hospitals and local communities across the country.
  • 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:
  • The most recent COVID-19 Science Update from the CDC is here
  • The ACL and CMS host a monthly webinar series that invites subject matter experts and practitioners from across the home-and-community-based services (HCBS) spectrum to share insights and best practices to develop high quality HCBS services and programs. Next month's webinar will be, "Reducing Food Insecurity and Nutrition-Related Chronic Diseases During COVID Among Medicaid HCBS Beneficiaries."  
  • DoD officials provided a briefing on the Department's COVID-19 vaccine distribution plan. The transcript is available here
  • The last FDA virtual Town Hall for SARS-CoV-2 test developers will be Dec. 16 at 12:15 PM. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
  • As of Dec. 9, 298 tests and sample collection devices are authorized by FDA under EUAs; these include 229 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests.
  • On Tuesday, Dec. 8, President Trump signed an EO to focus vaccination efforts on the U.S. before facilitating international access. The Order does not create any new rules or prevent pharmaceutical companies from entering into bilateral agreements with foreign nations.
  • Negotiations about a COVID-19 supplemental funding package in Congress remain stuck as there has been no agreement on liability protections. 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 15,271,571 total cases and 288,762 deaths. The CDC data closes out the day before reporting
  • The National Governors Association, in collaboration with the Duke-Margolis Center for Health Policy and the COVID Collaborative, released a report on Supporting an Equitable Distribution of COVID-19 Vaccines: Key Themes, Strategies, and Challenges Across State and Territorial COVID-19 Vaccination Plans. The paper provides a qualitative analysis of all publicly available state and territorial COVID-19 vaccination plans to support identification of key issues and sharing of promising practices.
  • The National Academy for State Health Policy has released a new blog analyzing state COVID-19 vaccine distribution plans and a chart of each state's phased approach to vaccinating priority populations.
  • More than a third of Americans are living in areas where hospitals are running critically short of ICU beds. Hospitals across the country are operating near or above capacity as they cope with a growing flood of COVID-19 cases. Nearly a third of U.S. hospitals have more than 80 percent of their ICU beds filled. 
  • On Wednesday, the U.S. set a new record for daily death toll, with 3,053 in just 24 hours. Just as the U.S. surpassed 280,000 deaths from coronavirus on Saturday, Dec. 5, the country was likely to pass 290,000 deaths late yesterday. 
  • New York Gov. Andrew Cuomo (D) directed the state’s department of health to begin implementing a "surge and flex" protocol and mandated all hospitals begin expanding their bed capacity by 25 percent to further prepare hospitals for an expected COVID-19 surge.  
  • Gov. Cuomo also issued a call to all retired doctors and nurses, urging them to return to service if they are able. 
  • New Mexico on Thursday suspended all nonessential surgeries and activated “crisis care” standards, a move that allows hospitals to ration care amid a surge in COVID-19 cases that has overwhelmed the state’s capacities. Elective surgeries will be banned until Jan. 4, and health care providers will be permitted to implement a statewide plan to stretch the state’s medical resources. 
  • Pennsylvania announced statewide restrictions that ban indoor dining and close gyms, theaters, and casinos for three weeks. Indoor gatherings will be limited to 10 people. 
  • Massachusetts Gov. Charlie Baker (R) announced the state will revert to Step 1 of Phase 3 of its reopening plan, requiring indoor performance venues and certain "high-contact indoor recreational businesses" to shut down. Retail shops, arcades, museums, offices, and places of worship will be allowed to operate at 40 percent capacity; outdoor gatherings are limited to 50 people; anyone planning to host a gathering of 25 people or more outside will be required to notify their local health board; and dining will be caped to 90 minutes of service for groups no larger than six people. 
  • Virginia Gov. Ralph Northam (D) announced a new EO that imposes an expanded mask mandate, smaller limits on social gatherings, and a new nightly curfew from midnight to 5 AM. 
  • Oklahoma Gov. Kevin Stitt (R) on Thursday announced several new restrictions on social gatherings and businesses. Public gatherings such as weddings and funerals are limited to 50 percent capacity unless the local health department grants an exception; attendance at youth indoor sporting events is limited to four spectators per participant or 50 percent of the building’s capacity; bars and restaurants close at 11 PM each night except for drive-thru or takeout services; and dining tables must be spaced 6 feet apart and that bars. Places of worship are excluded from restrictions. 
  • North Carolina Gov. Roy Cooper (D) announced that the state will begin a modified stay-at-home order. The order, which takes effect on Friday and will remain in place until Jan. 8, requires people to stay at home between the hours of 10 PM and 5 AM. 
  • North Dakota Gov. Doug Burghum (R) announced the extension of a statewide mask mandate until Jan. 18 and occupancy restrictions on restaurants, bars, and event venues until Jan. 8. 
  • Washington Gov. Jay Inslee (D) announced a three-week extension of statewide restrictions to mitigate the spread of COVID-19 and the extension of 26 proclamations related to the pandemic. 
  • Iowa Gov. Kim Reynolds (R) announced she is extending until Dec. 16 a COVID-19 emergency proclamation that imposed some mask requirements and put limitations on gatherings.  
  • Maine Gov. Janet Mills’s (D) administration announced it will extend the requirement for certain businesses statewide to close by 9 PM through Jan. 3.  
  • Colorado Gov. Jared Polis (D) extended a statewide mask order for an additional 30 days and an EO that allows for the operation of alternate care sites in response to COVID-19.   
  • California Gov. Gavin Newsom (D) announced the statewide launch of CA Notify, a new digital tool that will help reduce the transmission of COVID-19. 
  • Connecticut Gov. Ned Lamont (D) signed an EO that authorizes licensed pharmacists to administer any coronavirus vaccine that has been authorized by the FDA under certain conditions and caps the amount that providers may charge to administer COVID-19 vaccines, to ensure that no one is required to pay out-of-pocket costs for the vaccine. 
  • New Jersey Gov. Phil Murphy (D) signed an EO that automatically enrolls residents who choose to receive a COVID-19 vaccine into the state’s existing vaccine registry. 
  • Utah Gov. Gary Herbert (R) said the state’s teachers and school administrators will be eligible to receive COVID-19 vaccines as a part of phase one, directly after health care workers. Herbert said he expects teachers will be able to be vaccinated by the end of December or early January. 
  • Pennsylvania Gov. Tom Wolf (D) has tested positive for COVID-19. 
  • New Hampshire state Rep. Dick Hinch (R) has died of COVID-19 one week after being sworn in as House speaker. 
  • 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 you 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.
    • This series of maps shows how states are responding to COVID-19.
Science, Lifestyle, and Economy
  • Johnson & Johnson is reducing the size of its U.S. COVID-19 vaccine trial from 60,000 volunteers to 40,000 volunteers. The J&J candidate is currently the only single-dose vaccine being tested in a major study. The change in study size is possible because of the prevelance of COVID-19 and the increased likelihood that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial.
  • Doctors still aren’t sure why “long-haulers” continue to suffer the consequences of the disease months later or whether the symptoms will stay with them for the rest of their lives. But public health experts say it’s increasingly clear that many thousands of patients face long-term effects from the virus.
  • A survey from the Associated Press-NORC Center for Public Affairs Research shows about a quarter of U.S. adults are not sure if they want to get vaccinated against the coronavirus. Roughly another quarter say they will not.
  • A new series of polling from the de Beaumont Foundation explores the partisan divide between how Republicans and Democrats respond to communication about COVID-19. One question showed that 62 percent of Democrats said the current situation with COVID is “extremely serious,” compared with only 33 percent of Republicans feeling the same way. 
  • Airlines and freight say they will need regulatory flexibility in order to distribute a COVID-19 vaccine requiring ultra cold storage efficiently, including being able to move the vaccine through borders and customs with the appropriate safeguards to prevent tampering and theft. In considering the need for dry ice to help with cold storage, the Federal Aviation Administration has permitted United Airlines, which is conducting charter flights from Brussels to Chicago with Pfizer’s vaccine, to carry 15,000 pounds of dry ice on charter flights carrying the vaccine — five times more than the roughly 3,000 pounds normally permitted. 
  • A recent MMWR article found that, among parents of school-aged children who participated in an Internet panel survey, racial and ethnic minority parents were more concerned about some aspects of school reopening, such as compliance with mitigation measures, safety, and their child contracting or bringing home COVID-19, than were non-Hispanic White parents. 
  • A second MMWR study from this week's edition found that, during the COVID-19 pandemic, the total number of emergency department visits related to child abuse and neglect decreased, but the percentage of such visits resulting in hospitalization increased.
  • Officials have warned that hackers are targeting K-12 schools in a new wave of cyberattacks that is disrupting distance learning even as coronavirus cases spike across the country. Some of the hackers behind ransomware have held school data hostage or threatened to leak confidential student data if a payment was not made. Over the past month, the attacks have taken more than a hundred schools in Baltimore offline. They have also hit dozens of schools in Texas and Alabama, as well as a handful of schools in Georgia and Ohio.
  • 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. This AVAC pipeline tracker is great, too. 
  • 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.
International Affairs
  • 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.
  • A total of four countries have approved the Pfizer and BioNTech COVID-19 vaccine. Britain and Bahrain were the first countries to do so. Saudi Arabia’s food and drug authority approved the vaccine on Thursday, and Canada approved the vaccine on Wednesday. 
  • On Wednesday, the United Arab Emirates approved China’s coronavirus vaccine.  
  • Uzbekistan said large-scale trials of a Chinese-made COVID-19 vaccine would begin this week among its population. Phase 3 trials are also planned for Indonesia, Pakistan, and Ecuador. 
  • Argentina announced it will begin administering doses of Russia's Sputnik V COVID-19 vaccine later this month. 
  • The European Medicines Agency (EMA), the EU’s top drug regulator responsible for assessing coronavirus vaccines, suffered a cyberattack on Wednesday. The EMA is set to announce a decision on approval of the Pfizer and BioNTech vaccine by Dec. 29. 
  • António Guterres, the secretary general of the U.N. denounced “vaccine nationalism” on Wednesday, emphasizing the importance of ensuring access to the coronavirus vaccine in poor countries as well as wealthy ones.  In about 70 developing countries, only one in 10 residents is expected to receive a coronavirus vaccine within the next year. 
  • Hospitals in Tokyo were strained as Japan’s capital city reported 602 new cases on Thursday, its first time topping 600 cases in a day. Only around 3 percent of hospital beds were available for severe cases, and 17 percent were available for all patients. 
  • In Seoul, South Korea, 506 people were unable to be taken to hospitals this week due to hospital bed shortages. Authorities scrambled to build hospital beds in shipping containers to ease strains on medical facilities and plan to step up testing by launching 150 temporary sites across the greater Seoul area. 
  • ICUs in Stockholm, Sweden reached 99 percent capacity on Wednesday amid warnings that some patients may be refused treatment if hospitalizations continue to increase. 
  • Spain’s rate of confirmed COVID-19 cases has reached its lowest level since August. 
  • The French government on Thursday said that it will delay relaxing some COVID-19 lockdown restrictions, because rates of new infections are not falling as fast as expected. The reopening of theaters and museums, which was planned for Dec. 15, will be pushed back another three weeks, and a curfew that will replace the current lockdown will begin earlier than planned. 
  • Denmark’s government will expand tighter lockdown measures to 30 new municipalities. On Monday, the government announced a partial shutdown of 38 municipalities, including the capital Copenhagen, resulting in the closure of bars, restaurants, and museums. 
  • Slovakia ordered schools and most shops closed for at least three weeks beginning Dec. 21. The country also banned outside seating at restaurants beginning Dec. 11, only allowing carry-out as the number of COVID-19 cases continues to rise. 
  • High schools and colleges in Wales will move to online learning beginning on Monday. 
  • Israel on Wednesday reversed plans to impose a night-time curfew meant to prevent a new wave of coronavirus infections, minutes before the start of the Hanukkah holiday.  
  • An automated machine dispensing coronavirus test kits has been installed at a hospital in the Latvian capital of Riga. Currently, the machine is providing free 24-hour testing to staff at the Pauls Stradins Clinical University Hospital. The samples stored in the machine will be collected once a day. 
  • People using Google in Britain to search for vaccine information will be presented with a new knowledge panel tailored to their location, making it easier to connect people with authoritative sources as health officials  begin the momentous rollout of the first coronavirus vaccine. 
  • Belarus has said it will temporarily close its land border in late December to curb the spread of COVID-19. 
  • A passenger on board a Royal Caribbean “cruise to nowhere” was diagnosed with COVID-19, forcing the boat to return early to Singapore. 
  • Christmas mass in Bethlehem, normally attended by Christian congregations in the West Bank village, will be closed to the public this year due to COVID-19 restrictions. 
  • Global Cases: 69,728,763     Total Deaths: 1,584,788
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 Biotechnology Association, All rights reserved.


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