When was the Moderna COVID-19 vaccine approved?

On January 31, 2022, the FDA announced the second approval of a COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older.
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Is the Moderna COVID-19 vaccine FDA approved in the US?


Yes. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the vaccine. Data from these clinical trials supported the Emergency Use Authorization of Moderna COVID-19 Vaccine and the approval of SPIKEVAX (COVID-19 Vaccine, mRNA).

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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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Who makes Moderna's COVID-19 vaccine?


Manufacturer: ModernaTX, Inc.

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How long has the mRNA vaccine been around?

mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.
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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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What COVID-19 vaccines are using 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. What are mRNA Vaccines? 2/11

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Is there a difference between the Moderna COVID-19 booster and Moderna third shot?


In the case of Moderna, the booster dose is only half of the original dose. Unlike boosters, third/additional doses of COVID-19 vaccines are for people who received the complete starter series of vaccines but then their immune systems didn't have a good enough response.

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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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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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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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Is the COVID-19 vaccine effective?


COVID-19 vaccines are effective, but studies have shown vaccine protection declines over time especially with the Omicron variant. Learn more about getting a booster shot to enhance or restore protection against COVID-19.

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Do COVID-19 vaccines protect people from getting COVID-19?

COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and even dying—especially people who are boosted. As with vaccines for other diseases, you are protected best when you stay up to date with the recommended number of doses and boosters.

COVID-19 vaccines even offer protection to people who had COVID-19, including protection against being hospitalized from a new infection.

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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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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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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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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 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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Do COVID-19 boosters use the same ingredients as existing vaccines?

Yes. COVID-19 boosters are the same ingredients (formulation) as the current COVID-19 vaccines. However, in the case of a Moderna COVID-19 vaccine booster, the dose is half of the amount of the vaccine people get for their primary series.

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When should you usually get a COVID-19 booster vaccine?

1st Booster: Most people, at least 5 months after the final dose in the primary series. People who are moderately or severely immunocompromised, at least 3 months after the final dose in the primary series.
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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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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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Are mRNA COVID-19 vaccines safe?


mRNA vaccines are safe and effective.
mRNA vaccines have been held to the same rigorous safety and effectiveness standards as all other types of vaccines in the United States.

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What are the severe allergic reactions to COVID-19 mRNA vaccines?


“Overall, severe allergic reactions to COVID-19 mRNA vaccines, including life-threatening anaphylaxis reactions such as low blood pressure and difficulty breathing, are rare, on the order of five cases per million vaccine doses administered,” noted Dr. Guerrerio.

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