Is the Moderna COVID-19 vaccine FDA approved?

For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
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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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Are the COVID-19 vaccines approved by the FDA?

The vaccines met FDA's rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA). Learn more about EUAs in this video .
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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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Is the Moderna COVID-19 vaccine approved by EUA?


Data from these clinical trials supported the Emergency Use Authorization of Moderna COVID-19 Vaccine and the approval of SPIKEVAX (COVID-19 Vaccine, mRNA). Millions of individuals have received the vaccine under EUA since December 18, 2020.

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



Who makes Moderna's COVID-19 vaccine?


Manufacturer: ModernaTX, Inc.

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Does the American heart association recommend getting the COVID-19 vaccine?


The American Heart Association/American Stroke Association urges all U.S. adults and children 5 and older to receive COVID-19 vaccination as soon as possible to protect against severe illness from the coronavirus.

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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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What are the possible side effects of the Moderna COVID-19 vaccine?


Possible side effects: Pain, redness, swelling in the arm where the shot was administered; tiredness, headache, muscle pain, chills, fever, nausea throughout the rest of the body. If any of these side effects occur, they should go away in a few days.

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Is the ACON Flowflex COVID-19 test approved by the FDA?


This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.

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Is the Pfizer COVID-19 vaccine safe?


Pfizer-BioNTech COVID-19 Vaccine Ingredients. All COVID-19 vaccine ingredients are safe. Nearly all of the ingredients in COVID-19 vaccines are ingredients found in many foods – fats, sugars, and salts. The Pfizer-BioNTech COVID-19 vaccine (COMIRNATY) also contains a harmless piece of messenger RNA (mRNA).

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Has anyone gotten COVID-19 after being fully vaccinated?


Some fully vaccinated people—and those who have received boosters—have acquired SARS-CoV-2 and developed COVID-19. That is expected. One Mayo Clinic intensivist explains what to know about COVID-19 vaccination, boosters and breakthrough infections.

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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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Does the COVID-19 vaccine reduce the risk of getting "Long COVID"?

Reseach is showing that people who are vaccinated, even with just one dose, tend to have lower rates of long COVID-19 after catching the virus than those who are unvaccinated.
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How long does the protection from Pfizer and Moderna's COVID-19 booster vaccine last?


The most recent research from the CDC suggests that protection from the Pfizer and Moderna COVID-19 vaccines starts to fade around 4 months after a booster dose.

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What is the effectiveness of the COVID-19 vaccine?


COVID-19 vaccine efficacy or effectiveness against severe disease remained high, although it did decrease somewhat by 6 months after full vaccination. By contrast, vaccine efficacy or effectiveness against infection and symptomatic disease decreased approximately 20–30 percentage points by 6 months.

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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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Is it safe to get the COVID-19 vaccine?

Yes. All currently authorized and recommended COVID-19 vaccines are safe and effective, and CDC does not recommend one vaccine over another. The most important decision is to get a COVID-19 vaccination as soon as possible.
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Should I get vaccinated against COVID-19?

  • COVID-19 vaccines are safe and effective.
  • Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.
  • CDC recommends you get a COVID-19 vaccine as soon as you are eligible.
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Do people who have had COVID-19 have more side effects with the vaccine?

If you had COVID-19 before being vaccinated, the first injection may cause more noticeable side effects than for people who have not had the coronavirus. If you have never had COVID-19, you may notice more side effects after the second dose than after the first dose.

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