The same rigorous safety reviews of other vaccines authorized for use by the Food and Drug Administration (FDA) have been applied to COVID-19 vaccines.

• The FDA and Centers for Disease Control continue to monitor safety.
• The Emergency Use Authorization, or EUA, currently in place means that these vaccines are not fully approved or yet licensed by the FDA.
• The FDA only authorizes emergency vaccine use when the expected benefits outweigh potential risks.
• An EUA is issued based on the review of the scientific evidence available at this time that shows a vaccine is generally safe and effective.
• The vaccines approved for emergency use underwent the most intensive safety monitoring in U.S. history. Vaccine trials included more than seventy thousand participants from diverse backgrounds.

Beneficiaries may be hesitant to receive mRNA vaccines (Pfizer, Moderna) because they are new.

• mRNA technology stems from research that began in the 1990s. The advances made over nearly three decades of research helped companies to develop an mRNA vaccine quickly.
• Although the Pfizer and Moderna vaccines are the first mRNA vaccines, this technology has been under study for nearly three decades.
  • Based on this research, scientists know that mRNA vacines do not affect or interact with our DNA in any way. mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept.
• Unlike many vaccines that put a weakened or inactivated germ into our bodies, mRNA vaccines teach cells how to make a harmless “spike” protein, which is also found on the surface of the virus that causes COVID-19. This spike protein triggers an immune response.

Beneficiaries might not understand what viral vector vaccines (Janssen, or Johnson & Johnson) are and how they work.

• The Janssen COVID-19 (Johnson & Johnson) vaccine uses viral vector technology. Viral vector technology has been studied since the 1970s.
• Viral vector vaccines use a modified version of a different virus (the “vector”) to enter a cell in our body and then use the cell’s machinery to produce a harmless spike protein like the one found on the surface of the virus that causes COVID-19.
• This triggers the immune system to begin producing antibodies and activating other immune cells to fight off what it thinks is an infection.
• Viral vector vaccines cannot cause infection with COVID-19 or with the virus used as the vaccine vector.

The FDA and CDC continue to monitor the safety of COVID-19 vaccines. CDC has an independent group of experts that reviews all the safety data as it comes in and provides regular safety updates. The Janssen COVID-19 (Johnson & Johnson) vaccine pause demonstrates that the safety monitoring system is active.

How the COVID-19 vaccine safety monitoring continues:

• Vaccine Adverse Event Reporting System (VAERS)–This system collects and analyzes reports of adverse events that happen after vaccination. Anyone can submit a report, including parents, patients and health care professionals.
• Vaccine Safety Datalink (VSD)–VSD is a collaboration between CDC and nine health care organizations that monitors safety of vaccines and conducts studies about rare and serious adverse events following immunization. The VSD conducts vaccine safety studies based on questions or concerns raised from the medical literature and reports to the VAERS.
• Post-Licensure Rapid Immunization Safety Monitoring (PRISM)–PRISM can analyze health care information from over 190 million people. Scientists use these systems to actively monitor vaccine safety.
• Clinical Immunization Safety Assessment Project (CISA)–CISA is a collaboration between CDC and 7 medical research centers. Vaccine safety experts assist American health care providers with complex vaccine safety questions about their patients. Vaccine recommendations may change if safety monitoring reveals new information on vaccine risks, such as a new serious side effect.

Beneficiaries who choose not to get a COVID-19 vaccine are at a greater risk of getting sick. Research has not proven how long immunity lasts after having COVID-19. There have been cases of patients who have contracted COVID-19 twice.

• It is predominantly a respiratory illness that can affect other organs.
• People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness and death. Symptoms may appear 2 to 14 days after exposure to the virus.
• Multiple variants of the virus that causes COVID-19 are currently circulating globally and in the United States. Scientists are working to learn why these variants seem to spread more easily and quickly, which may lead to more cases of COVID-19.

Three out of four people reported a sore arm as their only COVID-19 vaccine side effect.

Other side effects may include:

• Injection site pain, swelling, and/or redness
• Fever
• Headache
• Fatigue
• Muscle and joint pain
• Chills
• Nausea
• Swollen lymph nodes
• Rare allergic reactions

The Food & Drug Administration (FDA) authorizes emergency vaccine use only when the expected benefits outweigh potential risks.

1. Anaphylaxis: Anaphylaxis after COVID-19 vaccination is rare and occurred in approximately 2 to 5 people per million vaccinated in the United States based on events reported to VAERS. This kind of allergic reaction almost always occurs within 30 minutes after vaccination.
2. Thrombosis with thrombocytopenia (Janssen): As of May 4, 2021, more than 8.4 million doses of the J&J/Janssen COVID-19 Vaccine have been given in the United States. Through continuous safety monitoring, CDC and FDA identified 23 confirmed reports of people who got the J&J/Janssen COVID-19 Vaccine and later developed TTS.
3. Deaths: More than 245 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 through May 3, 2021. During this time, VAERS received 4,178 reports of death (0.0017%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines.

Criteria to be considered “up to date on COVID-19 vaccination”

• Be advised you are not considered up to date on COVID-19 vaccination until two weeks after your second dose in a 2-dose series, such as Pfizer or Moderna.
• If you received Johnson & Johnson’s Janssen vaccine, you are considered up to date on COVID-19 vaccination two weeks after a single dose.
• If you don’t meet these requirements, regardless of your age, you are NOT up to date on your COVID-19 vaccination. Keep taking all precautions until you are up to date.

Source: CDC. When You’ve Been Fully Vaccinated

Safety of COVID-19 vaccines

• Over 302 million doses of COVID-19 vaccine have been given in the United States since December 2020.
• COVID-19 vaccines are safe and effective. They met the Food and Drug Administration’s (FDA) rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA).
• These vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history. This monitoring includes using both established and new safety monitoring systems to make sure that COVID-19 vaccines are safe.

Source: CDC. Safety of COVID-19 Vaccines

Vaccine effectiveness against variants

• Current data suggest that COVID-19 vaccines authorized for use in the United States offer protection against most variants currently circulating in the United States. However, variants will cause some vaccine breakthrough cases.

Source: CDC. COVID-19 Vaccine Breakthrough Case Investigation and Reporting

For guidance on what booster you’re eligible for, visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html.

A vaccine builds an immune response that protects a person’s health and the health of other people.

• The Pfizer-BioNTech, Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines were developed to prevent infection from the virus that causes COVID-19.
• Clinical trials for COVID-19 vaccines were five times larger than normal drug testing standards.

The COVID-19 vaccines:

• Don't contain the live virus that causes COVID-19. You can't get COVID-19 from these vaccines.
• Don't affect or interact with our DNA in any way.
• Have gone through the same safety tests and meet the same standards as any other vaccines produced through the years. There's a system in place that allows the CDC to watch for safety issues and make sure the vaccines stay safe.