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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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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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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Is the Pfizer COVID-19 vaccine approved by the FDA?

Continued use of the Pfizer-BioNTech COVID-19 vaccine, now fully approved by the FDA in persons aged ≥16 years, is recommended based on increased certainty that its benefits (prevention of asymptomatic infection, COVID-19, and associated hospitalization and death) outweigh vaccine-associated risks.
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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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Conversation with Albert Bourla, CEO of Pfizer | Davos | #WEF22



Are the FDA-approved vaccines effective at preventing COVID-19?


Yes. All FDA-approved and FDA-authorized COVID-19 vaccines prevent COVID-19 and serious health outcomes that COVID-19 can cause, including hospitalization and death.

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When was Johnson and Johnson COVID-19 vaccine approved?


The Johnson & Johnson single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an EUA in the United States on February 27, 2021 and Conditional Marketing Authorization (CMA) by the European Commission on March 11.

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When was Pfizer-BioNTech COVID-19 vaccine approved?

Pfizer-BioNTech (COMIRNATY) received U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals 16 years of age and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 Vaccine.
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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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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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What is the best vaccine for COVID-19?


In most situations, mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna) are preferred over the J&J/Janssen COVID-19 vaccine for primary and booster vaccination due to the risk of serious adverse events.

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Is the Johnson and Johnson COVID-19 vaccine authorized for use in the US?


The Johnson & Johnson COVID-19 vaccine, also known as the Janssen COVID-19 Vaccine, is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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Who makes Moderna's COVID-19 vaccine?


Manufacturer: ModernaTX, Inc.

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How effective is the Moderna COVID-19 vaccine?


Effectiveness of the Pfizer vaccine reached a peak of 96% at two months and remained around 90% at seven months and effectiveness of the Moderna vaccine reached a peak of 97% at two months and remained at 94% at seven months.

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

The most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, nausea and vomiting, swollen lymph nodes in the same arm of the injection and fever. Side effects typically started within two days of vaccination and resolved two or three days later.
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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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What are the common side effects of the Pfizer-BioNTech COVID-19 vaccine?


Commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite.

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Is it safe to take the COVID-19 vaccine?

The benefits of COVID-19 vaccination continue to outweigh any potential risks. CDC is providing timely updates on the following adverse events of interest: Anaphylaxis after COVID-19 vaccination is rare and has occurred at a rate of approximately 5 cases per one million vaccine doses administered.
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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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Can you get COVID-19 from sex?

All close contact (within 6 feet or 2 meters) with an infected person can expose you to the virus that causes coronavirus disease 2019 (COVID-19) — whether you're engaged in sexual activity or not.
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What data did the FDA use to make the decision to authorize Pfizer-BioNTech COVID-19 Vaccine for emergency use?

FDA evaluated and analyzed the safety and effectiveness data from clinical trials conducted in tens of thousands of study participants and manufacturing information submitted by Pfizer-BioNTech.

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When was Molnupiravir for COVID-19 approved in the UK?


Molnupiravir received its first approval on 4 November 2021 in the UK for the treatment of mild to moderate COVID-19 in adults with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic test and who have at least one risk factor for developing severe illness.

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How does the Johnson and Johnson COVID-19 vaccine work?


The J&J/Janssen COVID-19 vaccine also contains a piece of a modified virus that is not the virus that causes COVID-19. This modified virus is called the vector virus. The vector virus cannot reproduce itself, so it is harmless. This vector virus gives instructions to cells in the body to create an immune response.

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Is it safe to take the Johnson and Johnson COVID-19 vaccine?


For many people, the benefits of the Johnson & Johnson vaccine outweigh the risks. It's effective at preventing severe illness, hospitalization, and death from COVID-19, and it's the only single-dose option available. However, you'll still need to get a booster shot 2 months later.

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Is the Johnson and Johnson COVID-19 vaccine a viral vector vaccine?


The Johnson & Johnson Janssen vaccine, a viral vector vaccine, is among the COVID-19 vaccines authorized for emergency use in the United States.

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