U.S. Food and Drug Administration sent this bulletin at 09/01/2021 09:19 AM EDT
The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about vaccines, medicines for COVID-19, and ivermectin.
Q: What is the FDA’s role in approving vaccines?
A: The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory, clinical and manufacturing data to ensure the safety, effectiveness, and quality of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine’s safety, effectiveness, or possible side effects.
On Aug. 23, 2021, the FDA approved the first COVID 19 vaccine, which is manufactured by Pfizer-BioNTech and which will be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine also continues to be available under emergency use authorization (EUA), including for people ages 12 to 15, and for the administration of a third dose in certain immunocompromised individuals. More information on the approval can be found here.
On Dec. 11, 2020, the FDA authorized the Pfizer-BioNTech COVID-19 Vaccine for emergency use. On Dec. 18, 2020, the FDA authorized the Moderna COVID-19 Vaccine. And on Feb. 27, 2021, the FDA authorized the Janssen COVID-19 Vaccine, also known as the Johnson & Johnson vaccine. The issuance of an EUA is different than an FDA approval (licensure) of a vaccine.
In addition to supporting product development for high-priority COVID-19 vaccines, the FDA continues to provide timely advice and interact with vaccine developers on clinical trials for additional vaccine candidates. For more information, see FDA Vaccine Facts: The Path for Vaccines from Research to FDA Approval and this page on vaccine development.
Q: Are there any FDA-approved drugs (medicines) for COVID-19?
A: Yes. The FDA has approved Veklury (remdesivir) for certain COVID-19 patients.
Additionally, during public health emergencies, the FDA may in certain circumstances 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.
Q: Should I take ivermectin to prevent or treat COVID-19?
A: No. Although there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19.
You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.
The FDA has continued concerns that people are using animal formulations of ivermectin to treat or prevent COVID-19 in humans. As noted in a Health Alert from the Centers for Disease Control and Prevention, poison control centers across the U.S. are seeing a sharp spike in reports of people suffering adverse health effects and overdoses after taking animal ivermectin. Even if animal drugs have the same active ingredient as an approved human drug, animal drugs have not been evaluated for safety or effectiveness in people.
Treating human medical conditions with veterinary drugs can be very dangerous. The drug may not work at all, or it could worsen the illness and/or lead to serious, potentially life-threatening health complications. Read more about ivermectin.
For the latest information about COVID-19, visit: