Is the Moderna COVID-19 vaccine FDA approved in the US?

June 17, 2022: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for children down to 6 months of age. View press release and press conference . On January 31, 2022, the FDA announced the second approval of a COVID-19 vaccine.
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Is the Moderna COVID-19 vaccine FDA approved?


After a year of use under an FDA-issued EUA and ACIP interim recommendation, the Moderna COVID-19 vaccine received full FDA approval and is recommended by ACIP for use in persons aged ≥18 years in the United States.

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Do the Moderna and Pfizer COVID-19 vaccines have full FDA approval?


The Pfizer/BioNTech and Moderna COVID-19 vaccines have received full approval by the Food and Drug Administration (FDA).

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When was the Moderna COVID-19 vaccine approved?


On January 31, 2022, the Food and Drug Administration (FDA) granted full approval to the Moderna COVID-19 vaccine for persons aged ≥18 years.

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Who makes Moderna's COVID-19 vaccine?


Manufacturer: ModernaTX, Inc.

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Coronavirus Update 117: Moderna vs. Pfizer COVID 19 Vaccine (mRNA vaccines)



Which COVID-19 vaccines are based on mRNA technology?


The vaccines made by Pfizer-BioNTech and Moderna use mRNA to fight COVID-19. When these vaccines were rolled out, it was the first time mRNA was used on humans in vaccine technology. While the concept is new to the public, the research has been around since the early 1990s.

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Can you mix and match the vaccines for your mRNA (Pfizer or Moderna) primary vaccination series?


No, vaccines used for the primary vaccination series should be same. However, if the mRNA vaccine product given for the first two doses is not available or is unknown, either Pfizer-BioNTech or Moderna COVID-19 vaccine (mRNA COVID-19 vaccines) may be administered.

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What COVID-19 vaccines are approved by the U.S. Food and Drug Administration (FDA)?


Accepted COVID-19 Vaccines

  • Vaccines approved or authorized by the U.S. Food and Drug Administration (FDA), which currently include: Johnson & Johnson's Janssen. Moderna. Pfizer-BioNTech.
  • Vaccines listed for emergency use by the World Health Organization (WHO), which currently include: Johnson & Johnson's


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When was the COVID-19 treatment Paxlovid approved by the FDA?

FDA authorized Paxlovid (nirmatrelvir and ritonavir) in December 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19
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Are Pfizer and Moderna vaccines effective against COVID-19?

Researchers in the United States have shown that the Pfizer/BioNTech and Moderna messenger RNA (mRNA) vaccines are effective at generating T-cell immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the agent that causes coronavirus disease 2019 (COVID-19).
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Are there any safety concerns concerning mRNA technology of the Pfizer-BioNTech COVID-19 Vaccine?

FDA does not have specific safety concerns with a vaccine that utilizes this technology.

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Is it safe to take the Moderna, Pfizer-BioNTech, or J&J COVID-19 vaccine during pregnancy?

No safety concerns were found in animal studies: Studies in animals receiving a Moderna, Pfizer-BioNTech, or Johnson & Johnson (J&J)/Janssen COVID-19 vaccine before or during pregnancy found no safety concerns in pregnant animals or their babies.
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Did the FDA limit the use of the Johnson and Johnson COVID-19 vaccine?


May 6, 2022 – The FDA is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

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Has anyone had severe reactions to the Moderna COVID-19 vaccine?


Monitoring of the Moderna COVID-19 vaccine has found 10 cases of anaphylaxis after the administration of 4,041,396 first doses of the Moderna COVID-19 vaccine. In 9 out of these 10 cases of anaphylaxis, the recipient of the vaccine had onset of symptoms within 30 min of administration.

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What are the possible side effects of the Moderna and Pfizer COVID-19 vaccines?


Possible side effects: Pain, redness, or swelling at the site where the shot was administered, and/or tiredness, headache, muscle pain, chills, fever, or nausea throughout the rest of the body. If these side effects occur, they should go away in a few days. A few side effects are serious, but rare.

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Are long term side effects possible with COVID-19 vaccination?


Serious side effects that could cause a long-term health problem are extremely unusual following any vaccination, including COVID-19 vaccination. The benefits of COVID-19 vaccination outweigh the known and potential risks.

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What are some benefits of taking the COVID-19 treatment Paxlovid?

Paxlovid is an oral antiviral pill that can be taken at home to help keep high-risk patients from getting so sick that they need to be hospitalized. So, if you test positive for the coronavirus and a health care provider writes you a prescription, you can take pills at home and lower your risk of going to the hospital.
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Is Remdesivir approved for treatment of COVID-19?

Remdesivir is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged ≥12 years and weighing ≥40 kg).
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Is there an emergency use authorization of Paxlovid for COVID-19 in the US?


The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg)

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What are the name of all the COVID-19 vaccines?

Three COVID-19 vaccines are used in the United States to prevent COVID-19. Pfizer-BioNTech or Moderna are COVID-19 mRNA vaccines and are preferred. You may get Johnson & Johnsons Janssen (J&J/Janssen) COVID-19 vaccine in some situations.
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Can I choose which COVID-19 vaccine I get?

Yes, depending on your age, you can choose which COVID-19 vaccine to get. For adults ages 18 years and older, the mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna) are preferred over Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccine. You may get J&J/Janssen COVID-19 vaccine in some situations.

Currently, Pfizer-BioNTech COVID-19 vaccine is the only COVID-19 vaccine available to children ages 5 through 17 years old.

Learn more about your COVID-19 vaccination, including how to find a vaccination location, what to expect at your appointment, and more.

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Can you mix and match Pfizer and Moderna COVID-19 vaccine?


Through the FDA's authorization and the CDC's recommendation, heterologous boosting—aka “mixing and matching”—is allowed with a single dose of any of the authorized COVID-19 vaccine boosters. For example, those who got Johnson & Johnson's one-dose series can receive a booster shot from Moderna or Pfizer

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Can you mix and match COVID-19 booster shots?

The FDA has authorized the use of mix-and-match booster doses for currently available COVID-19 vaccines based on the results of a NIAID-supported study.

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Are egg products used in COVID-19 vaccines?

The COVID-19 vaccines currently authorized by the FDA are not manufactured using egg products or egg culture. See COVID-19 vaccines for more information.
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How do I know if I’ve been fully vaccinated if I was vaccinated in another country?

If you have received all recommended doses of a COVID-19 vaccine that has been authorized or approved by the U.S. Food and Drug Administration (FDA) or is listed for emergency use by the World Health Organization (WHO), then you are considered to be fully vaccinated.
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