COVID-19 Therapeutics

Assistant Secretary for Preparedness & Response (ASPR) and the COVID-19 Therapeutic Response

Hello, I’m Cicely Waters, the Director of External Affairs for the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. Today, I will provide a brief background about ASPR’s role in emergency response, including the COVID-19 pandemic. More specifically, I’ll discuss ASPR’s role in the distribution of COVID-19 therapeutics and how our partners—like you—can help inform and educate providers and potential patients about COVID-19 treatments.

Our role at ASPR is to help communities prepare for, respond to, and recover from incidents that effect the strength of our nation’s health care system. ASPR partners with hospitals; health care coalitions; biotech firms; community members; and state, local, tribal, and territorial governments across the country to improve readiness and response capabilities.

Since late 2019, ASPR has focused much of its efforts on the COVID-19 pandemic.

Our current key efforts include:

1. Responding well and quickly to emerge from the COVID-19 pandemic by leading the ongoing coordination of the COVID-19 response across the Department of Health and Human Services.
2. We are restoring resources and capabilities diminished during the pandemic, such as the Strategic National Stockpile, along with securing the public health supply chain.
3. And we are focusing on preparing for future emergencies by constantly scanning the horizon to be ready for whatever disaster or emergency may come next, whether that’s natural or man-made.

Part of this work includes the fair and equitable distribution of COVID-19 therapeutics.

How is ASPR helping to ensure equitable access to these critical drugs?

Throughout the course of the pandemic, the federal government has purchased and distributed numerous COVID-19 therapeutic products, for free, including oral antiviral medications and monoclonal antibodies, also known as mAbs. We have worked with state and territorial health departments to quickly get the treatments to where they are needed most in communities across the country. We are also providing therapeutics directly to Federally-funded Health Centers and Federal Retail Therapeutic Pharmacy Partners to help reach all populations.

A national initiative known as Test to Treat also offers an additional pathway for access to COVID-19 treatments. Through the Test to Treat initiative, individuals can get tested, see a health care provider and, if appropriate, receive a prescription for COVID-19 treatment and have the prescription filled—all in one location or through the support of telemedicine. Since these drugs must be taken within 5 days of first COVID-19 symptoms, every day counts! We’ve also made available an online locator that helps find Test to Treat sites in your community. We also have educational and outreach tools available to help inform providers and potential patients about available COVID-19 therapeutics. For more information please see the Test to Treat video in this series and additional resources found in the description.

Because we all know that accurate information can be the difference between life and death, ASPR provides several COVID-19 therapeutic resources to help health care professionals understand the differences between the treatments, patient eligibility criteria, and where products can be found. Our Clinical Implementation Guide is a detailed look at each of the available therapeutic products. We also offer a handy Side-by-Side Outpatient Therapeutics Table that gives a snapshot overview and comparison of the drugs. Our Decision Aid resource is a quick glance tool to assist health care professionals with identifying which therapeutic may be appropriate for their patients.

For more information, ASPR has created a COVID-19 therapeutics website. Here you will find a variety of resources, starting with important updates at the top of the page. Next you will find the featured resources including the Clinical Implementation Guide, the Side-by-Side Table, and the Decision Aid as well as a page that identifies where the COVID-19 therapeutics are distributed across the country. In addition, you will find individual product pages for each available COVID-19 therapy.

For more information about each of the COVID-19 therapeutic products and their distribution, please see the other videos in this series and other federal resources provided in the description, such as the CDC website and COVID.gov.

Within the ASPR website, you can find many more resources. I would like to specifically highlight a Digital Toolkit that can serve as a ready-made resource that you can use to help inform and educate your networks about available COVID-19 therapeutic products. For example, on the Test to Treat Digital Toolkit page there are downloadable messages, images, and motion graphics that are available and already sized to match different social media platforms.

It truly takes all of us to help ensure providers and potential patients know that these products are available and how they should be used. So, how can YOU help spread the word about COVID-19 therapeutics?

Please use your website, social media channels, newsletters, email distribution, coalitions, and other networks along with any other appropriate communications vehicles to highlight COVID-19 therapeutic options available in your communities because after all, we ARE in this together.

Please connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. You may also email questions regarding COVID-19 therapeutics to us at COVID19therapeutics@hhs.gov. Find us online, see the resources linked in the description, and I encourage you to watch the other Outpatient COVID-19 Therapeutics Videos in this series.

Thank you for your time and thank you for all you continue to do to combat COVID-19.

COVID-19 Therapeutics

Hello, I’m Dr. Derek Eisnor. I’m a Medical Officer for the Office of the Assistant Secretary for Preparedness and Response, or ASPR. ASPR operates within the U.S. Department of Health and Human Services, or HHS. Understanding which COVID-19 therapeutics are available for outpatient use and who is eligible will improve access and help ensure these lifesaving therapeutics are delivered in a fair and equitable manner.

What therapeutic options are available?

There are different therapeutic options for outpatients and inpatients who are in the hospital. This presentation focuses on outpatient COVID-19 therapeutic options. To be eligible for these outpatient therapeutic options your patient should be at a higher risk for developing serious symptoms of COVID-19. Other eligibility conditions and criteria apply for each treatment. To learn more about who is at high risk and COVID-19 treatment options, please see the other videos in this series as well as in the links in the description.

What are the outpatient therapeutic options?

Outpatient treatments can be divided into three categories: PrEP or pre-exposure prophylaxis—a preventative treatment for high-risk individuals before a possible exposure, PEP or post-exposure prophylaxis, and therapy for those who test positive for COVID-19.

What therapies are available for PrEP?

A preventative PrEP treatment available is Evusheld, a combination long-acting monoclonal antibody. Evusheld can help keep vulnerable people as well as those taking immunosuppressive drugs, such as chemotherapy or steroids, from progressing to severe disease or hospitalization if they later become COVID-19 positive. The drug can provide protection through prevention of severe illness in people not expected to mount an adequate immune response. Evusheld is not a substitute for vaccination.It is administered as intramuscular injections.

What therapies are available for PEP?

There are currently no PEP outpatient treatments. Doctors and scientists are working together studying new and improved treatments as the virus variants change during the pandemic.

What therapies are for people who test positive for COVID-19 and are not in the hospital?

If you test positive for COVID-19 there are different types of therapeutic treatments you may receive: oral antivirals, intravenous (IV) antivirals, and monoclonal antibodies, also called mAbs. These treatments are only effective at preventing severe disease or hospitalization if started within a specific limited time frame from onset of illness. Oral antiviral medications are pills and must be started within 5 days of symptom onset. Intravenous antivirals and mAbs need to start within 7 days of symptom onset.

Oral antivirals include Paxlovid or Lagevrio (or molnupiravir). They help fight the coronavirus infection by stopping the virus from replicating in the body. This lowers the viral load reducing the chances of the illness progressing to more serious symptoms and hospitalization. These medications need a prescription and must be started within 5 days of when symptoms first appear. They are taken as pills at home twice a day for 5 days.

ASPR distributes oral antiviral pills directly to participating Test to Treat pharmacy-based clinics and long-term care pharmacies making treatments available to eligible people in more locations. Test to Treat is an important initiative that allows people, who have limited access to a healthcare provider, an alternative location to get tested and, if positive and eligible, receive a prescription and medication—all at one location. For more information about the Test to Treat and Long-Term Care programs, please see the other videos in this series and the resources provided in the description.

Veklury is an intravenous antiviral. Like the oral antivirals, it fights the coronavirus infection by stopping the virus from replicating in the body, lowering the viral load. Veklury is given as an intravenous infusion and must be started within 7 days of symptom onset. It can be given in a number of locations like an infusion center once a day for 3 days.

A COVID-19 mAb includes bebtelovimab. It helps fight the coronavirus infection by blocking the virus from attaching to the body’s cells. This reduces the chances of the illness progressing to more serious symptoms and hospitalization. Bebtelovimab is given intravenously and must be taken within 7 days of symptom onset. It is administered one time.

How does one find COVID-19 therapeutics?

To find available therapeutics in your area, you can use the Test to Treat Locator for antivirals and the COVID-19 Therapeutics Locator for all treatments. To learn more about each of these treatments, watch the other Outpatient COVID-19 Therapeutics Videos in this series. Visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. Please email any questions to COVID19therapeutics@hhs.gov.

Thank you for your time.