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FDA - Food and Drug Administration

07/12/2021 | Press release | Distributed by Public on 07/13/2021 07:07

Learn More About COVID-19 Vaccines From the FDA

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

Pfizer BioNTech COVID-19 Vaccine

Moderna COVID-19 Vaccine

Janssen (sometimes called Johnson & Johnson) COVID-19 Vaccine

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 regulatory authority with 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 determine whether to authorize COVID-19 vaccines after they thoroughly analyze and evaluate the data related to safety, effectiveness and manufacturing quality. The FDA may issue an EUA when the agency's scientific experts have determined, among other things, that the known and potential benefits of the vaccine outweigh its known and potential risks.

FDA employees are also 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.

How do I get an authorized COVID-19 vaccine?

Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find COVID-19 vaccine locations near you in the U.S. In some states, information may be limited while vaccination providers and pharmacies are being added. Contact your state health department to find additional vaccination locations in your area.

FDA-authorized COVID-19 vaccines are distributed for free by states and local communities. You cannot buy COVID-19 vaccines online. You do not need to pay any out-of-pocket costs to get an authorized COVID-19 vaccine - not before, during, or after your appointment. If someone asks you to pay for your vaccine, it is either a scam or a mistake.

Do the authorized COVID-19 vaccines work?

Yes. All three FDA-authorized vaccines prevent COVID-19 and serious health outcomes that COVID-19 can cause, including hospitalization and deaths. The FDA thoroughly evaluated and analyzed the safety and effectiveness data for all of the authorized COVID-19 vaccines. The FDA 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 authorized COVID-19 vaccines work against variants of the virus that causes COVID-19?

The available information suggests that the authorized vaccines protect the American public against COVID-19 caused by currently circulating strains of the virus that causes COVID-19. We are already talking with vaccine manufacturers about how to tailor the vaccines to variant strains, should it be needed.

Some variants are more contagious and spread more easily from person-to-person 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.

What safety information is available about the authorized 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).

Over 300 million doses of COVID-19 vaccines have been administered in the U.S. and the ongoing post-authorization safety monitoring tells us that the known and potential benefits continue to outweigh the known and potential risks. The chance of developing a serious adverse event following vaccination is very low.

Allergic Reactions

Allergic reactions, including cases of anaphylaxis have happened after some people received a COVID-19 vaccine. 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.

Myocarditis and Pericarditis Following Vaccination with Moderna and Pfizer-BioNTech COVID-19 Vaccines

Reports to VAERS suggest increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with both Pfizer-BioNTech and Moderna COVID-19 vaccines, particularly following the second dose. Typically, onset of symptoms has occurred within a few days following vaccination.

Although the risks of myocarditis and pericarditis appears to be very low given the number of doses that have been administered for each of these vaccines, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning pertaining to the risk of myocarditis and pericarditis, and the Fact Sheet for Recipients and Caregivers includes information about myocarditis and pericarditis. For each vaccine, the warning specifically notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination. The Fact Sheets for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they experience any of the following symptoms:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart after vaccination

Based on available information of the confirmed reported cases of myocarditis or pericarditis, most affected individuals were hospitalized. But they responded well to treatment and rest, and their symptoms went away quickly.

FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.

Guillain Barré Syndrome Following Vaccination with Janssen COVID-19 Vaccine

Guillain Barré syndrome (a neurological disorder in which the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Weakness or tingling sensations, especially in the legs or arms, that's worsening and spreading to other parts of the body
  • Difficulty walking
  • Difficulty with facial movements, including speaking, chewing, or swallowing
  • Double vision or inability to move eyes
  • Difficulty with bladder control or bowel function

Blood Clots in Combination with Low Blood Platelets Following Vaccination with Janssen COVID-19 Vaccine

As a result of ongoing safety monitoring, the FDA and CDC recommended a temporary pause in the use of Janssen COVID-19 Vaccine, due to reports of a serious and rare type of blood clot in combination with low blood platelets (blood cells that help your body stop bleeding). This serious condition is called thrombosis with thrombocytopenia syndrome (TTS).

Why did the FDA and CDC lift the recommended pause in the use of the Janssen COVID-19 vaccine?

During the pause, the FDA reviewed all of the available data, including new information about TTS. Those data, plus the deliberations and recommendations of CDC's Advisory Committee on Immunization Practices (ACIP), informed our assessment and conclusion that the known and potential benefits of Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older.

On April 23, 2021, the FDA and CDC lifted the recommended pause on the Janssen COVID-19 Vaccine after this thorough safety review. The FDA amended the emergency use authorization of the Janssen COVID-19 vaccine to update the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include a warning about the risk of thrombosis with thrombocytopenia. The Fact Sheet for Recipients and Caregivers also includes information about blood clots with low blood platelets after receiving the Janssen COVID-19 Vaccine.

Am I at risk for blood clots with low blood platelets if I receive the Janssen COVID-19 Vaccine?

At this time, the available data suggest that the chance of blood clots with low blood platelets, also known as TTS, occurring after a person receives the Janssen COVID-19 Vaccine is very low. The investigation into level of potential excess risk due to vaccination is ongoing. We are closely monitoring the safety of the Janssen COVID-19 Vaccine and all other authorized COVID-19 vaccines.

In people who developed blood clots with low blood platelets after receiving the Janssen COVID-19 Vaccine, symptoms began about 1 to 2 weeks after vaccination. Reporting of these blood clots with low levels of platelets has been highest in females ages 18 through 49 years.

Get medical attention right away if you have any of these symptoms after receiving Janssen COVID-19 Vaccine:

  • Shortness of breath
  • Chest pain
  • Leg swelling
  • Persistent abdominal pain
  • Severe or persistent headaches or blurred vision
  • Easy bruising or tiny blood spots under the skin beyond the site of the injection

These may not be all the possible side effects of Janssen COVID-19 Vaccine. Serious and unexpected side effects may occur.

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.

COVID-19 Vaccine FDA Briefing Document Advisory Committee Meeting Webcast FDA Decision Memorandum
Pfizer-BioNTech
COVID-19 Vaccine
Pfizer-BioNTech December 10, 2020 Webcast

Pfizer-BioNTech (December 11, 2021)

Pfizer-BioNTech (May 10, 2021)

Moderna
COVID-19 Vaccine
Moderna December 17, 2020 Webcast Moderna
Janssen
(sometimes called
Johnson & Johnson)
COVID-19 Vaccine
Janssen February 26, 2021 Webcast Janssen

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 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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