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  1. Coronavirus Disease 2019 (COVID-19)

COVID-19 Frequently Asked Questions


Along with other federal, state, and local agencies and public health officials across the country, the FDA continues critical work to protect public health during the COVID-19 pandemic. Find the most recent FDA updates on our Coronavirus Disease 2019 page. 

The Centers for Disease Control and Prevention (CDC) has basic information about COVID-19 on their website at www.cdc.gov/coronavirus.

The frequently asked questions (FAQs) on this page are for a general public or consumer audience. Other audiences may want to refer to additional FAQs:

General Information 

Vaccines, Biologics, Human Tissues, and Blood Products

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 August 23, 2021, the FDA approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty (koe-mir’-na-tee), for the prevention of the disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for people 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. More information on the approval can be found here.

On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 Vaccine. On December 18, 2020, the FDA issued an EUA for the use of the Moderna COVID-19 Vaccine. And on February 27, 2021 the FDA issued an EUA for the use of the Janssen COVID-19 Vaccine. The issuance of an EUA is different than an FDA approval (licensure) of a vaccine.

In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits. And if the benefit-risk assessment is favorable, the product is made available during the public health emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine, the FDA then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the agency.

In addition to supporting product development for high priority COVID-19 vaccines, the FDA continues to expedite clinical trials for additional vaccine candidates, providing timely advice to and interactions with vaccine developers.

Vaccine developers can find more information about the review process here.

Drugs (Medicines)

A: FDA approval of a drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. The drug approval process takes place within a structured framework that includes collecting clinical data and submitting an application to the FDA. Learn more about the FDA’s Drug Review Process.

Medical Devices Including Tests for COVID-19

A: Yes, the FDA has issued Emergency Use Authorizations (EUAs) for different types of COVID-19 tests. Some tests are used to diagnose the virus that causes COVID-19 infection whereas other tests are used to detect a recent or prior COVID-19 infection. There are 2 different types of COVID-19 diagnostic tests -- molecular tests and antigen tests. Molecular tests detect the virus that causes COVID-19, SARS-CoV-2. Antigen tests detect specific proteins made by the virus. Tests that detect recent or prior COVID-19 infection are called antibody or serology tests. The EUAs allow the emergency use of tests during the COVID-19 emergency when the FDA determines certain criteria are met. These criteria include that the test may be effective at diagnosing COVID-19 and that the known and potential benefits outweigh the known and potential risks. Read more about COVID-19 tests and find a community-based testing site.

Food Products

A: To protect public health, the FDA monitors domestic firms and the foods that they produce. The FDA also monitors imported products and foreign firms exporting to the United States. The FDA protects consumers from unsafe foods through research and methods development; inspection and sampling; and regulatory and legal action.

Animals, Pets and Animal Drug Products

A: The FDA approves and regulates animal drugs to ensure they are safe and effective. In addition, the FDA helps ensure that animal food (including pet food) is safe and truthfully labeled. The FDA has post-market authority over veterinary medical devices.

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