COVID-19 Frequently Asked Questions | FDA

COVID-19 Frequently Asked Questions | FDA

Q: What is convalescent plasma and why is it being investigated to treat COVID-19?

A: Convalescent refers to anyone recovering from a disease. Plasma is the yellow, liquid part of blood that contains antibodies. Antibodies are proteins made by the body in response to infections.

Convalescent plasma from patients who have already recovered from coronavirus disease 2019 (COVID-19) may contain antibodies against COVID-19. The FDA has issued an Emergency Use Authorization for the use of convalescent plasma in hospitalized patients. It is also being investigated for the treatment of COVID-19 because there is no approved treatment for this disease.

Before issuing the EUA, the FDA concluded that, based on scientific evidence available, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product for patients hospitalized with COVID-19. Learn more about donating from this video.

Q: I recently recovered from COVID-19. Can I donate convalescent plasma?

A: COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood. Individuals must have had a prior diagnosis of COVID-19 documented by a laboratory test and meet other criteria. Individuals must have fully recovered from COVID-19, with complete resolution of symptoms for at least 14 days before donation of convalescent plasma.

You can ask your local blood center if there are options to donate convalescent plasma in your area. Learn more about how to donate.

Q: Are there any FDA-approved drugs (medicines) for COVID-19?

A: Currently there are no FDA-approved medicines specifically approved for the treatment or prevention of COVID-19. During public health emergencies, the FDA may authorize use of unapproved drugs or unapproved uses of approved drugs for life-threatening conditions when there are no adequate, approved, and available options and other conditions are met. This is called an Emergency Use Authorization (EUA).

Researchers are studying new drugs, and medicines that are already approved for other health conditions, as possible treatments for COVID-19. The FDA created the Coronavirus Treatment Acceleration Program (CTAP) to use every available method to move new treatments to patients.

Additionally, the FDA is working with the National Institutes of Health, drug manufacturers, researchers, and other partners to accelerate the development process for COVID-19 treatments. FDA’s Sentinel System is being used to monitor the use of drugs, describe the course of illness among hospitalized patients, and evaluate the treatment impact of therapies actively being used under real-world conditions.