In support of the national response to COVID-19, the Department of Health and Human Services (HHS) is distributing $175 billion from the CARES Act Provider Relief Fund (PRF) to hospitals and healthcare providers.  The PRF Frequently Asked Questions (FAQs) provide guidance to recipients regarding terms and conditions, attestation, reporting and auditing requirements, and the general and targeted distributions.  On November 18, new questions were added under the headings Use of Funds and Miscellaneous.

Helpful overviews include FDA Combating Covid-19 with Therapeutics and a video interview with the Operation Warp Speed lead on types of treatments and ongoing research.

• What treatments for COVID-19 are approved for use? As of Nov. 23, the FDA has approved one treatment for COVID-19, the antiviral drug Veklury (remdesivir), for use in adult and pediatric patients 12 years of age and older. Five other treatments are currently authorized for Emergency Use – including convalescent plasma and monoclonal antibodies.
• What’s the difference between convalescent plasma and monoclonal antibodies? Basically, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Convalescent plasma is from patients who have already recovered from COVID-19 and may contain antibodies against the virus.
• What other treatments are in development? FDA created the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of therapeutics.  As of Oct. 31, there were more than 370 active trials and more than 560 development programs for therapeutic agents in the planning stages. Visit the CTAP’s dashboard.
• Why is there a national call for plasma? As COVID-19 infections spike nationwide, the demand for convalescent plasma is outpacing donations. Americans who have recovered from COVID-19 in the last three months can donate now. Visit local blood collection center, American Red Cross or America’s Blood Centers or visit org to become a donor.

HHS Announcements & News

Vaccine Development and Distribution Update

• CDC’s Advisory Committee on Immunization Practices (ACIP) met last week and voted on general recommendations for how to prioritize vaccine distribution when supply is initially scarce.
• CDC then published the MMWR with their vaccine priority recommendations to jurisdictions. Bottom line: The 24 million vaccines will first take care of the 21 million healthcare workers and then approximately 3 million seniors and frail living in long term care facilities second.
• The 64 jurisdictions are working on distribution plans and will use these recommendations and their own best judgment to develop allocation plans based on what makes sense in their circumstances.
• , Dec. 10, FDA’s Vaccine Advisory Board will meet to discuss an emergency use authorization request for Pfizer’s vaccine.
• , Dec. 17, FDA’s Vaccine Advisory board will review the clinical trial data submitted by Moderna for emergency authorization of its vaccine.
• What can we do? When vaccines become available, it’ll be our turn to get vaccinated and encourage our communities to do the same. Read and share the CDC’s website and videos with quick things to know about the science of vaccines.

New Study on First U.S. Cases of COVID-19

CDC highlighted a study that shows that the virus that causes COVID-19 may have been in the U.S. as early as mid-December 2019, a month before the first confirmed case, based on antibodies found in donated blood.

COVID-19 Infection, Hospitalizations, and Deaths Among Persons Hispanic/Latinos

CDC released an MMWR for the period between March and Oct. in Denver, Colorado.  The majority of adult COVID-19 cases (55%), hospitalizations (62%), and deaths (51%) were among Hispanic adults, double the proportion of Hispanic adults (24.9%).

COVID-19 Emergency Webinar for Community Based Organizations: Vaccines

Wed., Dec. 16, 2020. 3:00 p.m. ET. Register here.

CDC Foundation President and CEO Dr. Judy Monroe, CDC Principal Deputy Director Dr. Anne Schuchat will discuss the current COVID-19 response, including the latest information about vaccines, and vaccine distribution plans. A local expert will also speak about vaccine-related challenges and opportunities.

Register now! USDA Faith Fellowship and Food Security Virtual Convening

USDA will host a Faith and Opportunity Fellowship convening bringing together faith leaders, faith-based organizations, and houses of worship to engage with peers, discuss common challenges, and hear best practices related to food security and community food system resilience.  Register here. Reach out to alex.cordova@usda.gov with any questions.

The Colorado Hospital Association (CHA) and its partners released a new resource to assist rural health care systems nationwide develop emergency response plans for COVID-19 and beyond. This playbook, Re-imagining Leadership: A Pathway for Rural Health to Thrive in a COVID-19 World, seeks to empower rural health care leaders create tailored responses that take the unique identities of their communities into account.

Rural communities nationwide have been particularly hard-hit by the COVID-19 pandemic, and the disparities facing rural health care systems are more apparent now than ever. Creating a meaningful resource to assist rural health care leaders weather these challenges requires the insight and direction of those on the frontlines within those communities. With that in mind, CHA and its partners distilled dozens of personal interviews, extensive literature review and an analysis of rural health care data into this playbook.

“There can be no scripted guide or silver bullet to address the unique challenges faced by each rural community,” said Benjamin Anderson, CHA vice president of rural health and hospitals. “That is why this playbook offers a framework that can be tailored to fit the individual strengths, challenges and identities of our rural partners here in Colorado and across the country.”

CHA was proud to partner with the Eugene S. Farley, Jr. Health Policy Center at the University of Colorado Anschutz Medical Campus on this playbook, which was made possible by generous funding from the ZOMA Foundation and CPSI.

About Colorado Hospital Association

Colorado Hospital Association (CHA) is the leading voice of Colorado’s hospital and health system community. Representing more than 100 member hospitals and health systems throughout the state, CHA serves as a trusted, credible and reliable resource on health issues, hospital data and trends for its members, media, policymakers and the general public. Through CHA, Colorado’s hospitals and health systems work together in their shared commitment to improve health and health care in Colorado.

The Technical Assistance and Services Center (TASC), in coordination with the Federal Office of Rural Health Policy (FORHP), are pleased to provide another update of the COVID-19 Funding Sources Impacting Rural Providers guide. This funding resource is intended to support rural health care providers, along with their state and local partners, navigate the availability of federal funds to support the novel coronavirus (COVID-19) pandemic response and recovery efforts. This guide is updated regularly to capture changes in funding sources.

Seven tables, or matrices, are provided for quick reference at the beginning of this resource. The tables can be used to check eligibility of participation in funding sources by provider types: rural prospective payment system (PPS) and critical access hospitals (CAH), rural health clinics (RHC), federally qualified health centers (FQHC), long-term care (LTC) or skilled nursing facilities (SNF), tribal facilities, and emergency medical services (EMS). The tables also provide an at-a-glance view for each provider type sharing the different types of funds that may be accessed from various funding sources dependent on their participation eligibility. Each funding source is described in its own section of this resource with an executive summary followed by further detail on the use of funds, reporting requirements, hyperlinks to the legislation and detailed information.

One of the main updates for this version is the addition of the RHC COVID-19 Testing Program found on Page 57.

The guide can be found in COVID-19 Collection located on The National Rural Health Resource Center’s website. This collection consists of trusted and reliable resources, such as the COVID-19 Funding Sources Impacting Rural Providers Guide, along with standing links to additional organizations’ COVID-19 resources, FAQs, webinars, tools, and trainings. The Center aims to help direct the most up-to-date and relevant tools and resources to rural hospitals, clinics, and their communities. This Collection will be updated regularly to help assist with the abundance of circulating information relating to COVID-19.

Pennsylvania Department of Conservation and Natural Resources (DCNR) Secretary Cindy Adams Dunn announced the department has canceled all in-person events and programs organized by its staff and volunteers in all state parks and forests, beginning Sunday, December 6.

“Safety of all our state park and forest visitors always has been paramount with DCNR and we are taking this temporary but necessary action in response to the continuing rise of COVID-19 cases across the state,” Dunn said. “Throughout the pandemic we have kept our lands open to all so they enjoy outdoor recreation and the positive physical and mental health it provides. That will not change but we must limit social interaction at this time.”

This decision, affecting approximately 150 planned events, will be in effect until further notice. People who have registered for programs will be notified.

This action also includes a move away from DCNR’s normally organized group First Day Hikes that were planned for New Year’s Day, January 1, 2021. Instead, many alternatives for individual hiking that day in state parks and forests will be made available later by DCNR.

State parks and forests will remain open for use by the public.  DCNR staff will be taking additional steps to offer self-guided programming only or virtual events. Check the Calendar of Events for scheduled programs.

Out-of-state visitors who are planning to stay overnight at state park and forest facilities must have a negative COVID-19 test within 72 hours of entering the commonwealth. If someone cannot get a test or chooses not to, they must quarantine for 14 days upon arrival in Pennsylvania before visiting a state park or forest. Pennsylvanians visiting other states are required to have a negative COVID-19 test within 72 hours of their return to the commonwealth or to quarantine for 14 days upon return. Visitors who don’t comply may be fined between $25 and $300.

The department’s most recent action is in line with other preventive steps taken, including requiring testing or quarantining for all out-of-state visitors to parks and forests.

Visitor center exhibit halls and interpretive areas will be closed, and all indoor programs will be canceled. Restrooms will continue to be available.

Masks must be worn:

• In park and forest offices;
• In any other indoor public space, including restrooms; and
• Outdoors when visitors are unable to adequately social distance.

Dunn noted visits to Pennsylvania state parks have increased by more than a million visitors a month since the start of mitigation efforts, and that interest is expected to hold strong through the winter and spring.

To help avoid exposure to COVID-19 and still enjoy the outdoors:

• Don’t hike or recreate in groups – go with those under the same roof, and adhere to social distancing (stay 6 feet apart)
• Take hand sanitizer with you and use it regularly
• Avoid touching your face, eyes, and nose
• Cover your nose and mouth when coughing and sneezing with a tissue or flexed elbow
• If you are sick, stay home

Visitors can help keep state parks and forest lands safe by following these practices:

• Avoid crowded parking lots and trailheads
• Bring a bag and either carry out your trash or dispose of it properly
• Clean up after pets
• Avoid activities that put you at greater risk of injury, so you don’t require a trip to the emergency room

Pennsylvania has 121 state parks and 20 forest districts; all are open year-round.

Information about state parks and forests is available on the DCNR website. Updates also are being provided on DCNR’s Facebook and Twitter accounts.

The Pennsylvania Department of Health notified health care providers that, effective immediately, it has aligned its quarantine guidance for people exposed to COVID-19 with the new guidance from the Centers for Disease Control and Prevention (CDC) announced earlier this week that provides an option for a 10-day quarantine without testing or a seven-day quarantine with a negative test on or after day-five of quarantine.

This guidance does not apply to health care settings or those living in certain congregate settings such as nursing homes or prisons.

“We must stop the spread of this virus and quarantining once you have been exposed is essential,” Secretary of Health Dr. Rachel Levine said. “The incubation period for COVID-19 remains at 14 days and it is still most protective to quarantine for the full two weeks. However, the CDC has affirmed that quarantine can end after 10 days if the person doesn’t develop symptoms, or after seven days if the person tests negative and has no symptoms.”

The department issued a Health Alert Network advisory today for health care providers outlining how to implement the new quarantine guidance. Quarantine may not be shortened to less than seven days. CDC recommends that people who have been exposed monitor their symptoms for the full 14-days after their last exposure.

The recommendation for a 14-day quarantine was based on the incubation period of the virus. CDC’s intention with the option to shorten quarantine is to gain better compliance with quarantine and contact tracing activities.

“If you have been identified as a close contact to someone diagnosed with COVID-19, are in quarantine and have no symptoms, you may get a test as soon as your fifth day of quarantine. If the results are negative you may end your quarantine after the seventh day of quarantine,” Dr. Levine said. “However, you will need to wait for a negative test result to stop quarantining. Providers should know that people seeking tests who are symptomatic should be placed above those seeking tests to shorten their quarantine.”

This recommendation also applies to all quarantine orders, including the travel orders issued on Nov. 25 by Dr. Levine.

Dr. Levine stressed that this does not change the need for Pennsylvanians to continue to wear masks, wash hands, avoid all gatherings and social distance. These efforts must continue to stop the spread of COVID-19.

With hundreds of thousands of workers in Pennsylvania relying on several federal unemployment programs that are set to expire at the end of the month, Governor Tom Wolf sent a letter today to the state’s Congressional delegation urging the federal government to continue the programs through 2021.

“The number of COVID-19 cases is surging now and expected to continue increasing in the weeks to come, endangering both the public and economy,” said Gov. Wolf. “I strongly urge you, our congressional delegation, to consider how important the CARES Act has been to our nation and our state in helping businesses and workers and in preventing further contraction of the economy, and to act swiftly to extend these programs.”

The governor’s letter outlines four recommended actions:

• Extend Pandemic Unemployment Assistance (PUA) Through 2021: PUA provides unemployment benefits to workers who are self-employed, seeking part-time employment, lack sufficient work history, or otherwise do not qualify for regular Unemployment Compensation (UC) or Extended Benefits (EB). PUA has provided more than $6.5 billion to Pennsylvania households and the economy.
• Extend Pandemic Emergency Unemployment Compensation (PEUC) Through 2021: PEUC provides up to 13 weeks of additional unemployment assistance to those who exhausted their benefits. PEUC has added $846.1 million to households in Pennsylvania.
• Renew Federal Pandemic Unemployment Compensation (FPUC): FPUC, which expired on July 31, 2020, provided $16.1 billion to eligible individuals through an additional $600 per week on top of their weekly UC benefit.
• Extend No-interest Loans to the UC Trust Fund Through 2021: Many states are borrowing from the federal government to pay the increased need for UC benefits. Pennsylvania has borrowed $618 million in loans that will begin accruing interest on Jan. 1, 2021 if the no-interest loan program expires. Extending the no-interest loans to states is critical to avoid significant increases in employer taxes and assessments as more Pennsylvanians are expected to need the benefits to afford housing, food and other basic needs.

Since March, the Department of Labor & Industry has paid more than $31.6 billion in total unemployment benefits.

With the surge in COVID-19 cases continuing, starting Monday, Dec. 7, the Pennsylvania Capitol Complex will close to the public until further notice. All operations of the Governor’s Office and General Assembly will continue, but access to the Capitol Complex will be limited to employees and people with badge keycard credentials.

The cancelation of visits and events applies to all interior venues in the Capitol Complex and will affect rallies, school or group tours, choir performances, receptions, and other public gatherings. The Capitol Complex includes, but is not limited to, the Main Capitol Rotunda, East Wing Rotunda, Keystone Building Atrium, Forum Auditorium and The State Museum of Pennsylvania.

To further support public health, the Department of General Services is encouraging Pennsylvanians to add their phone to the fight against COVID-19 by downloading the COVID Alert PA app. The free and voluntary mobile app can notify those who opt-in if you have had a potential exposure to someone who tested positive for COVID-19. In addition, the app provides timely alerts that can help you get advice on how to help yourself and protect others as well as determine when to get testing. It can help reduce your risk of unknowingly spreading the virus to your friends, family, and larger community. The free app can be found in the Google Play Store Opens In A New Window and the Apple App Store Opens In A New Window by searching for “covid alert pa.”

On December 3, Pennsylvania Governor Tom Wolf announced that U.S. Specialty Formulations (USSF), LLC, a pharmaceutical manufacturing company, will expand its operations in Allentown, Lehigh County to continue its work developing a COVID-19 vaccine in partnership with VaxForm, LLC. This project will create at least 97 new, high-paying positions at the site.

“There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” said Gov. Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

USSF will expand its 41,000-square-foot facility in Allentown and will request an FDA Emergency Use Authorization (EUA) approval to release a COVID-19 oral and injectable vaccine in mid-2021. In order to meet its schedule, the company must make renovations, acquire equipment, and hire new employees.

There is currently a global shortage of pharmaceutical manufacturing capacity, further exacerbated by the COVID-19 pandemic, and very limited capacity for clinical investigators to obtain appropriately documented clinical grade materials. USSF has been able to address both of these market challenges. USSF has also partnered with fellow Ben Franklin Technology Partners company VaxForm, LLC, to adapt an emergent oral vaccine platform technology to act as a vaccine for SARS-CoV-2 (COVID-19).

This oral platform was originally designed and has been successfully tested to show that it produces the antibodies required to generate immunity to Diphtheria, Tetanus (Lockjaw) and Pertussis (Whooping cough). After the COVID-19 genomic structure was identified, this oral platform was modified to generate the appropriate proteins to produce the proper immune response in mammals. USSF will be providing clinical materials from its Allentown plant for the human phase one clinical safety trials scheduled to begin in February 2021.

USSF received a funding proposal from the Department of Community and Economic Development (DCED) for a $291,000 Pennsylvania First grant and was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority loan. The company has committed to invest at least $5.2 million into the project and company will create 97 new, high-paying jobs and retain 14 more positions.

The project was coordinated by the Governor’s Action Team, an experienced group of economic development professionals who report directly to the governor and work with businesses that are considering locating or expanding in Pennsylvania.

“Completion of the USSF expansion will add a significant capability and capacity for our offerings and specifically to the oral Vaccine Platforms. As we continue the ramp for our Generation 1 and Generation 2 oral platforms, USSF will have the manufacturing space and human resources to deploy vaccines throughout PA and the world,” said USSF CEO Dr. Kyle Flanigan. “This is expected to have a dramatic positive impact on world health. The jobs created focus on biotechnology and advanced manufacturing capabilities, which are resilient to economic downturn. Further, the strategic location of this facility also allows USSF to support other vaccine formulation companies as the industry focuses on bringing this pandemic under control.”

The company also received more than $225,000 in funding from DCED through the COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program to support the rapid advancement of vaccines, treatments and therapies by qualified biotechnology entities in response to the COVID-19 pandemic. The program, announced in July, was made available to Pennsylvania-based entities that demonstrate both a financial need and a well-defined pathway to the accelerated commercialization of a new vaccine, treatment or therapy in direct response to fight against COVID-19.

“We are pleased to welcome USSF to the growing life sciences sector in the Lehigh Valley,” said Don Cunningham, president and CEO of the Lehigh Valley Economic Development Corporation (LVEDC). “USSF is on the front lines of the fight against COVID-19 and we’re glad to be home to its expanding operations. We appreciate the work of Governor Wolf and the Commonwealth to support the growth of this important company.”

USSF was founded in 2013 and produces a variety of pharmaceuticals in a state-of-the-art facility that exceeds quality standards outlined in U.S. Pharmacopeia (USP) and FDA guidelines, and adheres to the Current Good Manufacturing Practice (cGMP) and thereby lowers the total risk of using Outsourced Facility pharmaceuticals. The company utilizes a small batch disposable model to support healthcare providers and investigational new drug sponsors on a global scale. By registering some formulations under its FDA Outsourced Facility designation, USSF addresses the need caused by interruptions in the availability of specialty pharmaceuticals. USSF focuses on high-value formulations, allowing the company to provide a much larger portfolio of products to customers at both global and regional levels. USSF’s portfolio has expanded to include injectables and nasal presentations as well as tropical pharmaceuticals as a response to customer demands. The company is also the global single source of four prescription medications.

For more information about the Governor’s Action Team or DCED, visit dced.pa.gov, and be sure to stay up to date with all of our agency news on Facebook, Twitter, and LinkedIn.

On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” said HHS Secretary Alex Azar. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.”

You can read the full press release here