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COVID-19 Compilation – May 27, 2020 Courtesy of Cornerstone Government Affairs

Common Acronyms Centers for Disease Control and Prevention (CDC), World Health Organization (WHO), National Institutes of Health (NIH), Personal Protective Equipment (PPE), Department of Health and Human Services (HHS), Department of Defense (DOD), Department of Homeland Security (DHS), United States Department of Agriculture (USDA), Central Command (CENTCOM), Department of Housing and Urban Development (HUD), Centers for Medicare and Services (CMS), Transportation Security Administration (TSA), Department of Veterans Affairs (VA), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA)

Washington, D.C.

• The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.” The guidance provides a mechanism for FDA-regulated establishments (human food facilities and farms) to voluntarily notify the agency of temporary closures and significant reductions in operations and to request assistance from FDA on issues that might affect continuity of their operations during the pandemic. • The FDA issued a guidance document entitled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications” to provide answers to frequently asked questions. The agency is providing answers concerning certain aspects of sponsor requests for formal meetings with industry, user fee applications goals and timelines, and prioritization of drug and biological application reviews. • The FDA issued a letter to health care providers to remind reprocessing staff in health care facilities to use the correct sterilization cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. These sterilization systems help increase the availability of respirators by allowing decontaminated compatible respirators to be reused so health care workers on the front lines can be better protected when providing care to patients with COVID-19. • The FDA took a new step to support the agency’s evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA) and the FDA-supplied reference panel provides developers access to this material. The FDA’s reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-EUA process. • The FDA is hosting a virtual Town Hall on June 3rd at 12:15 PM for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for COVID- 19. • In response to the COVID-19 public health emergency, state and local governments, hospitals, and others are developing alternate care sites to expand capacity and provide needed care to patients. CMS published a fact sheet that provides state and local governments developing alternate care sites (ACSs) with information on how to seek payments through Medicare, Medicaid, and the Children’s Health Program (CHIP) for acute inpatient and outpatient care furnished at the site. The Federal Healthcare Resiliency Task Force issued a toolkit to help state and local governments develop an ACS. • The CDC published more new COVID-19 documents to its dashboard today. Some highlights are: funeral guidance, updated considerations for restaurants and bars, a revised map of travel recommendations by country, and financial resources. • Education Sec. Betsy DeVos acknowledged yesterday that tribal schools have not received their COVID-19 relief funds yet because the Bureau of Indian Education programs, the Education department, and the Interior department have not agreed on terms to distribute the money. • Sens. Maggie Hassan (D-NH), (D-NJ), Tim Scott (R-SC), and Kelly Loeffler (R-GA) wrote a letter to Education Sec. Betsy DeVos stating that the Department should provide more instructions to colleges handling financial aid appeals because of the pandemic, and that the Department should ask about loss of family income from the pandemic in the application for federal student aid. • Energy and Commerce Chairman Frank Pallone (D-NJ) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) sent a letter to FDA Commissioner Stephen Hahn today on the agency’s efforts to maintain food safety and address food supply disruptions in the U.S. during the COVID-19 pandemic. • A handful of COVID-19 hearings are slated to take place in the next few days: o Thursday (5/28) 10 AM Committee on Appropriations, VA Subcommittee, "VA Response to COVID- 19" (rescheduled and in-person) o Thursday (5/28) 10:15 AM Education and Labor, "Examining the Federal Government’s Actions to Protect Workers from COVID-19" o Friday (5/29) 1 PM Transportation and Infrastructure, "The Status of the U.S. Maritime Supply Chain During the COVID-19 Pandemic" • No significant changes here. Republicans and Democrats still remain divided over a few key issues including liability protections (both for employers and colleges), unemployment insurance, and funding for state and local governments, which will need to be addressed before the Senate will consider further COVID-19 legislation. For an in-depth briefing on the legislative landscape, please refer to the COVID-19 Legislative Update, which is published on Mondays, Wednesdays, and Fridays. If you do not receive the Legislative Update and would like to subscribe, email [email protected]

Updates from the States

• Out of the cases under investigation detected by U.S. surveillance, there are 1,678,843 total cases and 99,031 deaths The CDC data closes out the day before reporting. It is now being reported that the U.S. has surpassed 100,000 deaths. • is the most recent state to have recorded 100,000 cases. • Gov. (R) issued a proclamation that will enable water parks across to reopen at limited capacity under Phase 2 of reopening on May 29th. • Gov. (D) announced that Nevada is ready to move into Phase 2 of the reopening plan on May 29th including the reopening of casinos on June 4th. Additional businesses including personal services and gyms may open under new restrictions. • D.C. Mayor (D) announced today that she is signing an order to lift the district’s stay-at-home order beginning Friday after 14 days of decreased community spread. D.C. will enter Phase 1 of reopening with restaurants, barbershops and salons, and parks and recreational areas opening at limited capacity. • Gov. (D) announced that Rhode Island is on course to enter the second phase of its reopening plan on June 1st. While a focus on “keeping your group size small and consistent” will remain, the transition will allow virtually all sectors of the economy to resume activity in some form. • Maine Gov. (D) has announced another revision to her plan to reopen the state's economy as they approach stage 2 of the plan, which begins on June 1st. Gov. Mills now says restaurants in Androscoggin, Cumberland, and York counties are restricted to outdoor service, take-out, and delivery only, as opposed to being able to fully reopen to dine-in customers as the plan originally called for. • Gov. (D) signed a new state disaster declaration to ensure that Kansas can effectively respond to the current emergency situation, which includes an unprecedented economic emergency and the imminent threat of new outbreaks of COVID-19, specifically regarding food supply. • Virginia Gov. (D) announced that Northern Virginia is on track to join the rest of the state on Friday in phase one of the reopening process. Gov. Northam also signed an amended EO extending Virginia’s declaration and directed the Department of Labor and Industry to develop emergency temporary standards to prevent workplace exposure to COVID-19. • Gov. (D) released his Reopen Connecticut report, which contains recommendations from the Reopen Connecticut Advisory Group – the panel of local health, business, workforce, and education experts. • Washington Gov. (D) issued guidance further clarifying outdoor recreation requirements in Phase 1 and Phase 2. • California Gov. (D) announced that barbershops and salons can now begin to reopen under Phase 3 of the state’s reopening plan. • Gov. (D) announced that professional sports teams which train or play in are now authorized to practice and engage in games or matches if their leagues resume competition. He also announced that the New Jersey Department of Education and the Office of the Secretary of Higher Education will issue updated guidance allowing school districts and colleges/universities to hold modified in- person graduation ceremonies beginning on July 6th. • New Mexico Gov. (D) announced the state’s emergency public health order will be amended to permit limited outdoor dine-in services for most of the state beginning today. Dine-in services inside restaurants and bars remain temporarily closed. • Mississippi Gov. (R) announced that his Safer-at-Home Order will be replaced on June 1st with a Safe Return Order. Under the new order, all businesses can open, including movie theaters and ballparks, but they must follow the strict health guidelines in place. Indoor gatherings of no more than 50 people and outdoor gatherings of up to 100 people will be allowed in areas where social distancing is possible. Otherwise, no more than 20 people may gather indoors and no more than 50 may gather outside. The Safe Return Order will be in effect until June 15th. • Useful state data: o The NYT is tracking which states are reopening and which are still shut down. o These charts show cumulative coronavirus cases and deaths for metropolitan areas over time. o 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. o 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. o This site from the Kaiser Family Foundation provides state-level information on cases/deaths, social distancing measures, health policy actions, and more. o This resource from Bloomberg Law is a database of State Quarantine and Public Health Laws related to the COVID-19 response. o 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. o Finally, this site offers COVID-19 projections assuming full social distancing and can be broken down by state.

Military/Defense

• The U.S. Army’s newest short-range air defense system, the Interim Maneuver Short-Range Air Defense (IM-SHORAD), will be delayed due to COVID-19. o Army acquisition head Bruce Jette said programs in the two largest categories of acquisition programs remain on track for first unit equipped. • VA Sec. Robert Wilkie defended the Department’s use of hydroxychloroquine on veterans and promised to continue offering the drug to COVID-19 patients who have no other option. • The USS Kidd, which suffered a COVID-19 outbreak in April, will continue undergoing cleaning for two more weeks at Naval Base San Diego. The Navy will test all Kidd crew members again before the ship resumes its deployment. • The Navy issued new guidance for combating COVID-19 on ships at sea. Ships will now operate as clean “bubbles,” allowing aboard only those who have been medically screen and adhere to health mitigation measures, including social distancing and wearing face coverings. • Boeing will lay off 6,770 U.S. employees this week, while another 5,530 workers are taking buyout offers to leave voluntarily. A Boeing spokesperson said the company is attempting to limit job losses in its defense businesses.

International Affairs

• New Zealand now has zero COVID-19 hospital patients. There are still a couple dozen active cases in the country, but those patients are not being treated in a hospital. • Both chambers of the French Parliament voted in favor of the "StopCovid" app today, despite the contact tracing app being criticized by opposition parties for its infringements on individual freedoms. French digital rights association La Quadrature du Net said that between 60 and 80 percent of the population would need to use the app for it to help mitigate COVID-19. • According to Spain's top COVID-19 health ministry official, mortality rates in Spain were 55 percent higher than usual between March 10th and May 10th of this year. Not all of those additional deaths can be linked directly to COVID-19, but many of them are likely due to people not wanting to go to hospitals or get medical assistance during the peak of the pandemic. • El Salvador's president Nayib Bukele says he's taking hydroxychloroquine as a treatment to prevent COVID- 19 despite the drug's efficacy being repeatedly questioned for this use. • In fact, the French Health Ministry revoked its authorization for the drug to be given to those with COVID-19, saying that the scientific data available currently does not provide sufficient “evidence of a benefit” to support its use. • England announced plans to launch a "test and trace" system to track COVID-19 with a goal of replacing national lockdown restrictions. The contact tracing program will ask anyone with COVID-19 symptoms to isolate immediately, get a coronavirus test, and speak with the U.K.'s National Health Service (NHS) on a voluntary basis. Those who test positive will be contacted by the NHS within 24 hours. • Dubai’s Crown Prince Sheikh Hamdan Mohammed bin Rashid Al Maktoum has directed all government workers in Dubai to return to work by June 14th. • Moscow's Mayor, Sergey Sobyanin, announced that the city will begin to gradually ease some lockdown restrictions starting June 1st. Sobyanin said the Russian capital would allow the reopening of stores selling non-food items, and would allow some services to resume operation, including laundries, dry cleaners, and repair shops. • The head of the United Nations World Tourism Organization said today that global tourism is expected to plummet by 70 percent compared to last year. The Organization expects more international flights to resume in September if COVID-19 seems to be more under control. • Global Cases: 5,488,825 Total Deaths: 349,095

Lifestyle, Science, and Economy

• U.S. stocks surged today on optimism that economic activity is gathering steam and authorities may offer more stimulus to bolster the recovery. The S&P 500 closed out above 3000 for the first time in nearly three months. • A recent poll of nearly 2,000 voters from May showed that, across political parties, people largely believe COVID-19 testing should be required for employees and students returning to their places of work and study. Democrats who participated in the poll were about 20 percent more likely than their republican counterparts to say they backed mandatory testing. • A scientific brief has been published by WHO investigating any association between smoking and an increased risk for COVID-19. At the time of this review, the available evidence suggests that in hospitalized COVID-19 patients, smoking is associated with increased severity of disease and death. • After the English Premier League conducted more than 1,000 individual COVID-19 tests over the last two days, four players and staff from three clubs were found to have tested positive for the virus. My fingers are crossed that none of them play/work for Chelsea but, with my luck, they probably do. • Winegrowers in France have announced they will be thanking some of the country's front line healthcare workers by giving away 5,000 free bottles of champagne. • Similar to recent data showing that women in the U.S. were more likely to have lost employment than men, a new report in the U.K. shows that mothers in the country are more likely than fathers to have quit, lost their job, or to have been furloughed since the start of the country's lockdown. • ’s Kindle and Echo engineer teams are pivoting to work on the company’s COVID-19 testing project. • Ancestry and 23andMe have started researching the genetic factors affecting COVID-19, after conducting a nationwide survey of customers to cross-reference with their DNA. • 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. • WHO has published a population-based age-stratified seroepidemiological investigation protocol for COVID- 19 virus infection. This protocol was designed to investigate the extent of infection, as determined by positive blood tests in the general population, in any country in which COVID19 virus infection has been reported. • 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. • Forbes is keeping a running list of all major international airline COVID-19-related change and cancellation policies. • RetailDive tracks store reopenings in the U.S.

Helpful Articles/Media

• Daily WHO Situation Report (5/27) • Research finds concerning drop in U.S. colorectal cancer screenings and surgeries (spoiler: it's because non-urgent appointments and screenings have been put off due to COVID-19) • Contact Tracing Can Do a Lot More Than Find Coronavirus Cases • In the Pipeline: Coronavirus Vaccine Update, May 26 • Fate of Global Economy Rests More Than Ever on Finding Vaccine • Study Reveals Coronavirus Immunity Only Lasts for 6 Months Casting Doubts on 'Immunity Passports’ for Survivors • 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. • How the pandemic has changed the natural world, illustrated • Resolve to Save Lives has released, “Staying Alert: Navigating COVID-19 Risk Toward a New Normal.” In the report, RSL recommends a four-tiered, color-coded system that grades the current state of risk from red, “4-Very High Risk,” to green, “1-New Normal.” The system is summarized here. • Why do some COVID-19 patients infect many others, whereas most don’t spread the virus at all? • 9 ways Covid-19 may forever upend the U.S. health care industry • From CDC's Morbidity and Mortality Weekly Report: o Universal and Serial Laboratory Testing for SARS-CoV-2 at a Long-Term Care Skilled Nursing Facility for Veterans — Los Angeles, California, 2020 o Decline in Child Vaccination Coverage During the COVID-19 Pandemic — Michigan Care Improvement Registry, May 2016–May 2020 o High COVID-19 Attack Rate Among Attendees at Events at a Church — Arkansas, March 2020 o COVID-19 in Correctional and Detention Facilities — United States, February–April 2020 • "Looking for Clues" with CDC's CMO for COVID-19 response. • NIH Director: Defeating COVID-19 requires unprecedented action and collaboration • Watch a video replay of Clinical Trials in Public Health Emergencies: the Ebola and COVID Experiences • NIH Director's Blog: COVID-19 Brings Health Disparities Research to the Forefront • Soaring Prices, Rotting Crops: Coronavirus Triggers Global Food Crisis • From CDC's MMWR: Identification and Monitoring of International Travelers During the Initial Phase of an Outbreak of COVID-19 — California, February 3–March 17, 2020 • Virus Survivors Could Suffer Severe Health Effects for Years • A strategic approach to COVID-19 vaccine R&D, with Drs. Tony Fauci and Francis Collins as co-authors • When Coronavirus Hits Food Deserts • In a virtual town hall with the American Academy of Family Physicians, ASTHO CMO Marcus Plescia presented on the intersect between public and private sectors in the COVID-19 response. • Rapid COVID-19 vaccine development • Giving blood thinners to severely ill Covid-19 patients is gaining ground • Anne Schuchat, MD, Principal Deputy Director of the Centers for Disease Control and Prevention (CDC), discusses evolution of CDC guidance and latest developments in the COVID-19 pandemic. • Watch an NIH video about COVID-19 Diagnostics: The Challenge of Rapid, High-Volume Detection of SARS-CoV2 • Effect of Convalescent Plasma Therapy on Viral Shedding and Survival in COVID-19 Patients • What Antibody Studies Can Tell You — and More Importantly, What They Can’t • Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals (this would change the reopening of large buildings if found to be consistent) • From Dr. Tom Frieden: How to reopen society as soon and safely as possible • The Other COVID Risks: How Race, Income, ZIP Code Influence Who Lives Or Dies • Examining the social impact of COVID-19 • The Implications of COVID-19 for Mental Health and Substance Use • COVID-19 exacerbating inequalities in the US • The characteristics of household transmission of COVID-19 • ‘We need an army’: Hiring of coronavirus trackers seen as key to curbing disease spread • Suicide Mortality and Coronavirus Disease 2019—A Perfect Storm? • Safety at the Time of the COVID-19 Pandemic: How to Keep our Oncology Patients and Healthcare Workers Safe • The effective use of telemedicine to save lives and maintain structure in a health care system • Projecting hospital utilization during the COVID-19 outbreaks in the U.S. • Johns Hopkins data capture. • Other tracking data here.

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