In December 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the first two oral antivirals for the treatment of certain COVID-19 patients. These treatments mark a step forward in the fight against the pandemic, due to their ability to be taken at home, which can reduce the burden on both patients and the health care system. Additional treatments are also under investigation by several other biopharmaceutical companies.
Here’s what you should know about the newly authorized antivirals:
How are the newly authorized antiviral medicines different from previous COVID-19 treatments?
Earlier in the pandemic, the FDA approved another antiviral treatment for use in patients 12 years of age and older for the treatment of COVID-19, which is delivered via infusion in a hospital setting. That same treatment is now authorized for outpatient administration. Other types of treatments, known as monoclonal antibodies, are also delivered through infusion.
Oral antivirals, once widely available, are a significant step in expanding the toolbox of treatments outside of a hospital setting. Both of the antiviral treatments that recently received EUAs can be taken orally at home and have been shown to help reduce the likelihood a person needs to receive hospital care for a COVID-19 infection. Keeping patients at home and out of the hospital not only reduces the burden on patients, but also on the overall health care system.
What is the difference between an EUA and FDA approval?
Emergency use authorizations (EUAs) are used in certain emergency situations, like the COVID-19 public health emergency. They may only be issued if, among other things, FDA determines that there is no adequate, approved and available alternative to the EUA product. EUAs are used to facilitate access to medical interventions, such as vaccines and treatments, during certain emergency circumstances.
While an EUA is different than FDA approval, safety standards for all COVID-19 treatments are robust and no corners have been cut along the way. COVID-19 studies are subject to the same requirements, including safety monitoring, as all drug clinical trials.
How are these treatments different from vaccines?
Vaccines are given to people who are not infected, and work by training the body to develop antibodies that attack and destroy the virus – without causing an infection. The newly authorized antiviral treatments are meant for certain people who test positive for a COVID-19 infection, and are designed to disrupt the virus’s ability to replicate, thus shortening the time to recovery and lowering the likelihood for hospitalization.
Importantly, treatment is not a substitute for vaccination, and the best strategy to prevent infection and severe illness against COVID-19 is to get vaccinated.
What if I test positive for COVID-19?
The newly authorized oral antivirals represent another option in an all-hands-on-deck approach to fighting the pandemic in all its forms; however, they are not authorized for everyone with a COVID-19 infection. A doctor may prescribe one of the available treatment options for patients who meet certain criteria, including adults and patients 12 years or older who test positive results for the SARS-CoV-2 virus, and who are at high risk for progression to severe COVID-19, including hospitalization or death. If you test positive for COVID-19, it is critical to remember that your doctor is the only one who can advise whether the newly authorized COVID-19 antiviral treatments are appropriate for you.
What is the biopharmaceutical industry doing to ensure people can access COVID-19 treatments?
Biopharmaceutical companies are uniquely positioned to provide the complex manufacturing capabilities and technological expertise needed to bring these newly authorized antivirals forward for distribution. Throughout the pandemic, companies have been partnering with other manufacturers who are sharing available capacity to support production. These partnerships have been key to increasing manufacturing and distribution capacity and helping ensure patients can access treatments and vaccines. Similarly, the manufacturers of the newly authorized COVID-19 antivirals have entered into partnerships around the world to help increase access to low- and middle-income countries.
Patients should talk to their doctor to discuss whether any of the available treatments might be appropriate for them.
More than two years after the initial discovery of the SARS-CoV-2 virus that causes COVID-19, scientists continue to develop ways to fight back. The newly authorized antivirals represent an additional tool we have to address the pandemic and help reduce the burden on hospitals and the health care system. To learn more about how researchers continue to work around the clock to investigate new ways of fighting COVID-19, click here.
Richard Moscicki M D
Dr. Moscicki served as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA from 2017-summer of 2022. He joined the organization after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.
Richard Moscicki M D
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What you need to know about newly authorized COVID-19 antiviral treatments
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Vaccines
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What you need to know about newly authorized COVID-19 antiviral treatments
What you need to know about newly authorized COVID-19 antiviral treatments