The U.S. Food & Drug Administration has authorized three COVID-19 vaccines for emergency use. The vaccines are:
- Pfizer BioNTech COVID-19 Vaccine
- Moderna COVID-19 Vaccine
- Janssen COVID-19 Vaccine (Johnson & Johnson)
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 & Research (CBER).
Who approves COVID-19 vaccines?
The FDA is the agency responsible for regulating vaccines, including COVID-19 vaccines. FDA employees who are career scientists & doctors are the people who decided to authorize COVID-19 vaccines after they carefully review the data on COVID-19 vaccine safety, effectiveness & manufacturing quality. The FDA may issue an EUA when the agency’s scientific experts have determined that the known & potential benefits of the vaccine outweigh its known & potential risks. FDA employees are fathers, mothers, daughters, sons, sisters, brothers & more. They & 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 & make a difference for your children, parents, grandparents, & 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 against COVID-19 will help protect you from COVID-19, & it may also protect the people around you.
How do I get a COVID-19 vaccine?
Go to the Centers for Disease Control & Prevention (CDC) website to find your state & local health departments who are responsible for COVID-19 vaccine distribution. All questions & 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 & 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.
Does the COVID-19 vaccine work?
Yes. All three FDA-authorized vaccines are effective in preventing hospitalization & deaths from COVID-19 & may be given to any person eligible to receive a COVID-19 vaccine. The FDA carefully evaluated & analyzed the safety & effectiveness data for all COVID-19 vaccines & determined that all of the available data for each vaccine provides clear evidence that the known & potential benefits outweigh the known & potential risks of each vaccine’s use.
Do the COVID-19 vaccines work against the new variants?
While each FDA-authorized COVID-19 vaccine is slightly different, 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 & how to quickly & safely make any changes that may be needed in the future.
Some variants spread more easily than others. 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 & poorly ventilated indoor spaces
- Washing your hands often with soap & water (use hand sanitizer if soap & water aren’t available)
How safe are the COVID-19 vaccines?
The FDA evaluated data from clinical studies that included tens of thousands of people. The data from these studies clearly show that the known & potential benefits of the FDA-authorized COVID-19 vaccines greatly outweigh the known & potential risks.
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. No serious, life-threatening allergic reactions occurred in clinical study participants, however, after getting a COVID-19 vaccine in their community, a few people had anaphylaxis (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, health care providers may ask you to stay at the place where you received a vaccine for monitoring for 15 to 30 minutes.
To date the FDA & other government agencies have not identified any new safety signals that raise questions about the risks & benefits of COVID-19 vaccines. A safety signal is information from one or more sources, such as federal surveillance programs, that suggests an adverse event may potentially be related to a vaccine or medicine & that further evaluation through additional studies or close monitoring may be needed.
Can I see the data showing the COVID-19 vaccine is safe & effective?
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 see outside experts discuss the data on the advisory committee webcasts. 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||December 10, 2020 Webcast||Pfizer-BioNTech|
|Moderna||December 17, 2020 Webcast||Moderna|
|Janssen COVID-19 Vaccine|
(Johnson & Johnson)
|Janssen||February 26, 2021 Webcast||Janssen|
Does the FDA monitor COVID-19 vaccine safety after approval or authorization?
Yes. The FDA & the CDC have several systems in place to continually monitor COVID-19 vaccine safety. These systems, called “passive surveillance” & “active surveillance” systems, rapidly detect & investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System (VAERS) & 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.
- FDA: COVID-19 Vaccine Safety Monitoring
- FDA COVID-19 Vaccine Information: http://www.fda.gov/covid19vaccines
Source: FDA Consumer Updates