Vaccine safety given the speed of vaccine development and rollout
The federal government has worked since the start of the pandemic to make COVID-19 vaccines available as soon as possible. This accelerated timeline is unprecedented. Some people are concerned that vaccine safety may have been sacrificed in favor of speed. However, as with all vaccines, safety is a top priority in the United States and globally.
· Millions of people in the United States and around the world have received COVID-19 vaccines. These vaccines have undergone the most intensive safety monitoring in U.S. history.
· The United States is using established and new safety monitoring systems to make sure that COVID-19 vaccines are safe.
· Results from US and global monitoring efforts are reassuring. No unexpected patterns of reactions or other safety concerns have been identified during early vaccine safety monitoring. And, if they show up, we have systems in place to quickly identify them and take action.
· All of the currently authorized and recommended COVID-19 vaccines, have been carefully reviewed by the Food and Drug Administration (FDA). FDA is responsible for reviewing all safety data from clinical trials to determine if the expected benefits of vaccination outweigh potential risks.
o Learn more about FDA’s emergency use authorization (EUA) in this video.
· The Advisory Committee on Immunization Practices (ACIP) reviewed all safety data before recommending the current COVID-19 vaccines for use. Learn how ACIP makes vaccine recommendations.
Natural immunity versus vaccine immunity
Because some people with COVID-19 can have very mild symptoms, some may see natural infection as preferable to receiving the COVID-19 vaccine. Some people may be concerned that getting a COVID-19 vaccine could make them sicker if they do get COVID-19.
· COVID-19 can cause severe illness or death, and we can’t reliably predict who will have mild or severe illness. You can also spread COVID-19 to others, including family. And, some people continue to have long-term health issues after COVID-19 infection.
· Getting COVID-19 may offer some natural protection, known as immunity. Current evidence suggests that reinfection with the virus that causes COVID- 19 is uncommon in the 90 days after initial infection. However, experts don’t know for sure how long this protection lasts, and the risk of severe illness and death from COVID-19 far outweighs any benefits of natural immunity.
· Currently available vaccines have been tested in large clinical trials and FDA has determined that they are safe and effective.
o The known and potential benefits of a COVID-19 vaccine must outweigh the known and potential risks of the vaccine for use under what is known as an Emergency Use Authorization (EUA). Watch a video on what an EUA is.
· Millions of Americans have already been vaccinated and these vaccines are undergoing the most intensive safety monitoring in U.S. history. The same vaccines are used globally and the World Health Organization reports that hundreds of millions of vaccinations have been administered.
· Once you’ve been fully vaccinated, you are able to more safely do some things, including travel.
Common vaccine side effects
Some COVID-19 vaccines may cause more reactions than other vaccines that people are more familiar with. It is important to understand this in case you experience a strong reaction after being vaccinated.
· Common side effects from vaccination are pain, redness, and swelling on the arm where the shot was given, and tiredness, headache, muscle pain, chills, fever and nausea throughout the rest of the body. Some people have no side effects.
· Side effects after the second dose, for vaccines that require two doses, may be more intense than the ones they experienced after the first shot.
· These side effects may affect your ability to do daily activities, but they should go away in a few days. Patients should seek medical care if their symptoms don’t go away.
· While COVID-19 vaccines may cause side effects, vaccines cannot give someone COVID-19.
· Side effects are normal signs that the body is building protection.
· It is not recommended to take over-the-counter medicine – such as ibuprofen, aspirin, or acetaminophen – before vaccination for the purpose of trying to prevent vaccine-related side effects.
· Please talk to us about any questions you may have about medications you are taking.
Serious, long-term, or unknown side effects
Due to the relative speed with which these vaccines were developed, patients’ concerns about long-term side effects are reasonable and to be expected. For other vaccines routinely used in the United States, the phases of clinical trials are performed one at a time. During the development of COVID-19 vaccines, these phases have overlapped to speed up the process so the vaccines can be used as quickly as possible to control the pandemic. No trial phases have been skipped.
· While COVID-19 vaccines have been developed rapidly, all steps have been taken to ensure their safety and effectiveness.
· In the United States, the FDA and CDC continue to monitor vaccine safety to make sure even long-term side effects are identified. Globally, many countries are also monitoring vaccine safety.
· COVID-19 vaccines are being continuously monitored for safety, and the FDA and ACIP will take action to address any safety problems detected.
How many doses are needed and why
The mRNA vaccines, Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine, require two shots. The same vaccine brand must be used for both shots. The viral vector vaccine, Johnson & Johnson’s Janssen COVID-19 Vaccine, only requires one shot.
· The Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine both need two shots in order to get the most protection.
· People should get their second shot even if they have side effects after the first shot, unless a vaccination provider or doctor has advised them not to get it.
· Only one shot of Johnson & Johnson’s Janssen COVID-19 Vaccine is needed to get the most protection.
· If two shots are required, the shots are given several weeks apart and both shots are generally needed to provide the best protection against COVID-19. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response.
· You will set up an appointment for you second dose before you leave.
· COVID-19 vaccines are not interchangeable with each other.
CDC does not recommend one vaccine over the other. You should receive the first vaccine available.
Which vaccine to get
Because there are different types of COVID-19 vaccines authorized and recommended, you may have questions about which vaccine brand you should get.
· All currently authorized and recommend COVID-19 vaccines are safe and effective, and CDC does not recommend one vaccine over another.
· Patients should get the first vaccine that is available to them. They should not wait for a specific brand.
· There is vaccination information available, including how to find a vaccination location, what to expect at their appointment, and more.
· Patients should know the benefits of getting a COVID-19 vaccine, including what they can start doing again once they are fully vaccinated.