Available COVID-19 Vaccines and Safety - Minnesota Dept. of Health
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Available COVID-19 Vaccines and Safety

COVID-19 vaccines go through different studies and checks (called clinical trials) to make sure they are safe, and that they work, before they are given to the public.

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

There have been four 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).

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 of the four vaccines have been approved for full licensure from FDA.

  • As of July 8, 2022, the Pfizer COVID-19 vaccine (also known as Comirnaty) has been approved for full FDA licensure for vaccination of people 12 years and older. People age 6 months-11 years, people age 5 and older with immunocompromising conditions needing an additional dose, and people needing a booster dose can continue to get Pfizer vaccine under the existing EUA.
  • As of Jan. 31, 2022, the Moderna COVID-19 vaccine (also known as Spikevax) has been approved for full FDA licensure for vaccination of people 18 years and older . People age 6 months-17 years, people 6 months of age and older with immunocompromising conditions needing an additional dose, and people needing a booster dose can continue to get Moderna vaccine under the existing EUA.

Once vaccines are approved by FDA, companies can market the vaccines under brand names. That's why the Pfizer vaccine is now also called Comirnaty. The FDA-approved Pfizer and Moderna COVID-19 vaccines are the same as the vaccines used under the EUA. Nothing changed besides the names when they were fully approved.

Johnson & Johnson COVID-19 vaccine is still available under an EUA for people age 18 years and older. The CDC recommends the Pfizer, Moderna, and Novavax vaccines over the Johnson & Johnson COVID-19 vaccine. Johnson & Johnson COVID-19 vaccine will continue to be available. Minnesotans who prefer this vaccine should have a conversation with their vaccine provider about the potential risks. Refer to CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines for more information.

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. Even if the vaccines do not work as well against some of the variant strains, scientists think the vaccines still offer protection and prevent serious illness, hospitalization, and death.

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). Learn more about mRNA vaccines at CDC: Understanding mRNA COVID-19 Vaccines.

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 Johnson & Johnson COVID-19 vaccine is made using a harmless cold virus, called an adenovirus. The adenovirus is grown using what is called an immortalized cell line, and the virus then is pulled out and purified. The cell line came from a legal abortion that occurred in 1985. This cell line has been maintained by Johnson & Johnson for decades to make life-saving vaccines and other medical products. The cells today are clones of the early cells, not the original tissue. There is not fetal tissue in the vaccine. Many faith groups and bioethics institutes have stated that people may ethically receive these vaccines when there is not an alternative vaccine.

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:

How we know the vaccine is safe

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. MDH is committed to making vaccines available that we are confident are safe and effective.

CDC and FDA continue to monitor the COVID-19 vaccines for safety once they are being used in the general population.

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

The requirements for COVID-19 vaccine are the same as all other vaccines. The companies making the vaccines have to share information with specific agencies like the FDA and CDC that shows how the vaccine studies were designed, what their process was, how they got their data, and what the results were.

Health officials, FDA, vaccine manufacturers, and others have committed to only put out vaccines that are shown to be safe. 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:

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.

Who is in the vaccine studies

The first vaccine studies are usually done with groups that are at highest risk for the disease, or who will get very sick if they get the disease.

Diverse and underserved communities

The COVID-19 vaccine clinical trials include people from diverse communities. It is important for these studies to have equitably more people from racially and ethnically diverse backgrounds. This way they have enough information to be confident that the vaccine is safe and works for these groups. It's especially important that COVID-19 vaccine trials include people from diverse communities, because these communities have been severely impacted by the disease and could greatly benefit from getting vaccinated.

Pregnant people and children

Then the studies are expanded to other groups such as pregnant people and people who are immunocompromised (cannot easily fight off a disease). For COVID-19 vaccine, studies focused on non-pregnant adults ages 18 years and older at first (16 years and older for Pfizer). Vaccine manufacturers have since expanded to include pregnant people and children in their studies.

More information

Updated Thursday, 08-Sep-2022 12:40:55 CDT