Learn More About COVID-19 Vaccines From the FDA

By | May 10, 2021

April 23, 2021: The FDA amended the emergency use authorization of the Johnson & Johnson (Janssen) COVID-19 vaccine to include information about a very rare and serious type of blood clot in people who receive the vaccine. View frequently asked questions about Janssen COVID-19 Vaccine…

Report vaccine side effects toll-free at 1-800-822-7967 or online to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

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The U.S. Food and Drug Administration has authorized three COVID-19 vaccines for emergency use. The vaccines are:

Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDA’s Center for Biologics Evaluation and Research (CBER).

Who authorizes COVID-19 vaccines for emergency use?

The FDA is the authority that has regulatory oversight of the safety, effectiveness and quality of vaccines that are used in the U.S., including COVID-19 vaccines. FDA employees who are career scientists and doctors are the people who decided to authorize COVID-19 vaccines after they thoroughly analyzed and evaluated the data on COVID-19 vaccine safety, effectiveness and manufacturing quality.

The FDA may issue an EUA when the agency’s scientific experts have determined that the known and potential benefits of the vaccine outweigh its known and potential risks. FDA employees are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are directly impacted by the work they do.

Why should I get a COVID-19 vaccine?

When you get a COVID-19 vaccine, you are choosing to protect yourself and make a difference for your children, parents, grandparents, and other loved ones. Millions of people in the U.S. have already received a COVID-19 vaccine. For a community to be fully protected, most community members need to get the vaccine. Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you.

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How do I get a COVID-19 vaccine?

Go to the Centers for Disease Control and Prevention (CDC) website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. All questions and concerns should be sent to your state government or local health department. The U.S. government’s goal is to have enough COVID-19 vaccine doses for all people in the U.S. who choose to be vaccinated.

FDA-authorized COVID-19 vaccines are being distributed for free by states and local communities. If you see vaccines for sale online, or if someone asks you for money to get a vaccine appointment, to put your name on a waiting list, or to get access to a vaccine, it is a scam. You do not need to pay to get a vaccine appointment or to be put on a waiting list.

Do the COVID-19 vaccines work?

Yes. All three FDA-authorized vaccines are effective in preventing COVID-19 and related serious outcomes, including hospitalization and deaths.  The FDA thoroughly evaluated and analyzed the safety and effectiveness data for all of the authorized COVID-19 vaccines and determined that the available data for each vaccine provides clear evidence that the known and potential benefits outweigh the known and potential risks of each vaccine.

Do the COVID-19 vaccines work against the new variants?

The available information suggests that the authorized vaccines remain effective in protecting the American public against currently circulating strains of COVID-19. We are already talking with vaccine manufacturers about these new strains and how to quickly and safely make any changes that may be needed in the future.

Some variants spread more easily than others and are more transmissible than the original virus that causes COVID-19. To help slow the spread of COVID-19, get a COVID-19 vaccine when it is available to you. Other ways to slow the spread include:

  • Wearing a mask
  • Keeping 6 feet apart from others who don’t live with you
  • Avoiding crowds and poorly ventilated indoor spaces
  • Washing your hands often with soap and water (use hand sanitizer if soap and water aren’t available)
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How safe are the COVID-19 vaccines?

The FDA evaluated data from clinical studies that included tens of thousands of people for each COVID-19 vaccine. The FDA authorized the vaccines because the data from these studies clearly showed that the known and potential benefits of the FDA-authorized COVID-19 vaccines outweighed the known and potential risks.

Report vaccine side effects toll-free at 1-800-822-7967 or online to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Millions of doses of FDA-authorized COVID-19 vaccines have been given to people all around the country. Serious adverse events following vaccination are very rare. Allergic reactions, some of which are severe, and cases of anaphylaxis have occurred following administration of COVID-19 vaccines. Anaphylaxis is a severe, life-threatening allergic reaction that happens within seconds or minutes of exposure to an allergen. Because of this remote chance of severe allergic reaction or anaphylaxis, health care providers may ask you to stay at the place where you received your COVID-19 vaccine for monitoring for 15 to 30 minutes.

For one vaccine, the Janssen COVID-19 Vaccine, there have been cases reported to the Vaccine Adverse Event Reporting System (VAERS) of a type of blood clot called cerebral venous sinus thrombosis (CVST) in combination with low levels of platelets in the blood (thrombocytopenia). CVST occurs when a blood clot forms in the brain’s venous sinuses. This prevents blood from draining out of the brain. It is a type of rare stroke.

On April 13, 2021, the FDA and CDC recommended a pause in the use of this vaccine out of an abundance of caution while it further investigates these cases and to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

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Can I see the safety and effectiveness data that support the Emergency Use Authorization of the COVID-19 vaccines?

The FDA is publicly sharing information about COVID-19 vaccines so you can see the evidence for yourself. The FDA’s analysis of clinical trial data, as well as demographic information about the clinical study volunteers, is available in the FDA Briefing Document for each vaccine. You can also view the advisory committee webcasts where outside experts discuss the data. The FDA’s reasoning for authorizing each vaccine is available in the FDA Decision Memorandum.

Does the FDA monitor COVID-19 vaccine safety after authorization?

Yes. The FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety. These systems, called “passive surveillance” and “active surveillance” systems, rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System (VAERS) and CDC’s text-based v-safe system, which receive reports of adverse events following vaccination, are examples of passive surveillance systems. The FDA‘s BEST Initiative is an example of an active surveillance system, which can rapidly analyze information occurring in millions of individuals recorded in large data systems to investigate any safety signals that are identified by VAERS or v-safe.

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