Available COVID-19 Vaccines and Safety

On this page:
Authorized and approved vaccines
Protection against variant strains
What the vaccines are made of
How we know the vaccine is safe
Making a safe and effective vaccine
Who is in the vaccine studies
More information

Authorized and approved vaccines

At this time, there are three COVID-19 vaccines licensed (approved) for use or authorized for use under an emergency use authorization (EUA) by the Food and Drug Administration (FDA) and recommended for use by the Centers for Disease Control and Prevention (CDC).

• FDA: Pfizer-BioNTech COVID-19 Vaccine
• FDA: Moderna COVID-19 Vaccine
• FDA: Novavax COVID-19 Vaccine, Adjuvanted

All currently available COVID-19 vaccines were initially authorized by EUA. An EUA is used in public health emergencies when: A product shows that it likely works, is safe but hasn't yet gone through the whole process of FDA licensure, and no other remedy is available.

An FDA-approved vaccine means that it went through FDA's standard process for reviewing the quality, safety, and effectiveness of medical products. It is FDA's expectation that after a vaccine gets an EUA, the vaccine manufacturer will continue their clinical studies to gather additional safety and effectiveness information. The vaccine manufacturer should also work towards submitting a biologics license application (BLA) for FDA licensure of the vaccine as soon as possible. FDA reviews all of this information to make sure the vaccine meets their standards for approval.

Two vaccines have been approved for licensure from FDA.

• The Pfizer COVID-19 vaccine, called Comirnaty, received FDA licensure for vaccination of people 12 years and older.
• The Moderna COVID-19 vaccine, called Spikevax, received FDA licensure for vaccination of people 18 years and older.

The FDA-approved Pfizer and Moderna COVID-19 vaccines are the same as the vaccines used under the EUA.

You have the right to refuse or accept the COVID-19 vaccine, as stated in the EUA fact sheets. We strongly encourage you to get the COVID-19 vaccine if it is available to you. Getting the vaccine will help protect you and your family, co-workers, residents, patients, and community.

Protection against variant strains

We are still learning about new variants. The data we have so far shows that the COVID-19 vaccines are working against the variant strains to prevent severe illness that results in hospitalization or death. Protection against any disease symptoms disappears over time. This means people will need to get COVID-19 vaccination periodically. At this time, experts suggest an annual vaccination with a formula that closely matches the current variant that is circulating.

What the vaccines are made of

The COVID-19 vaccines that are available are not live virus vaccines. This means that they cannot give you COVID-19. After getting the vaccine, you will not shed live virus around your home or put others in your household at risk of COVID-19 disease. The vaccine will not affect a COVID-19 test.

The Pfizer and Moderna COVID-19 vaccines were made using mRNA technology. mRNA stands for messenger ribonucleic acid. mRNA is not able to alter or modify a person's genetic makeup (DNA).

The Novavax vaccine authorized for people 12 and older is a protein vaccine. This vaccine uses copies of the spike protein from the SARS-CoV-2 virus (the virus that causes COVID-19) to teach your immune system how to recognize the virus and prepare to fight it.

The available COVID-19 vaccines do not contain a preservative. They do not contain gelatin or eggs. For more information about ingredients, refer to the FDA vaccine fact sheets available in multiple languages.

For specific concerns about certain ingredients visit:

• Children's Hospital of Philadelphia: Vaccine Ingredients
• Immunization Action Coalition: Talking About Vaccine

How we know the vaccine is safe

The requirements for COVID-19 vaccine are the same as all other vaccines. Having a safe and effective vaccine is the top priority. The manufacturers must present the study data that shows the vaccine is safe and that it works before it is authorized or licensed (approved) for general populations. This data is closely reviewed by several scientific groups at the FDA and CDC. The CDC Advisory Committee on Immunization Practices (ACIP) and other groups look at available information about a vaccine and make informed decisions about the risks and benefits of using it.

CDC and FDA continue to monitor the COVID-19 vaccines for safety once they are being used in the general population. The FDA has given guidance to vaccine manufacturers about what information is needed to prove that a vaccine is safe, and that the vaccine works. For more details about expectations and commitments, refer to:

• Statement about COVID-19 vaccine planning
• The FDA's Scientific and Regulatory Oversight of Vaccines is Vital to Public Health
• Biotechnology Innovation Organization: An Open letter to the Biopharmaceutical Industry (PDF)

Learn more about how vaccines are made from the Children's Hospital of Philadelphia at Making Vaccines.

The CDC has more information on COVID-19 vaccine safety at Ensuring the Safety of COVID-19 Vaccines in the United States

Making a safe and effective vaccine

How COVID-19 Vaccines Are Made (PDF)
This handout explains how the COVID-19 vaccine processes and timelines were made more efficient compared to other vaccine development.
12/21/20