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Is The COVID-19 Vaccine Approved By The FDA?

Asked by: Gay Shields
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If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction, even if it was not severe, to any ingredient in an mRNA COVID-19 vaccine (such as polyethylene glycol), you should not get an mRNA COVID-19 vaccine.

When was the Moderna COVID-19 vaccine approved?

Moderna COVID-19 Vaccine

On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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.

Can I get the COVID-19 vaccine if I am pregnant?

CDC strongly recommends COVID-19 vaccination either before or during pregnancy, because the benefits of vaccination for both pregnant persons and their fetus/infant outweigh known or potential risks. Getting a COVID-19 vaccine can prevent severe illness, death, and pregnancy complications related to COVID-19.

Is it safe to take the J&J/Janssen COVID-19 vaccine?

After receiving the J&J/Janssen COVID-19 Vaccine, there is risk for a rare but serious adverse event—blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS). Women younger than 50 years old should especially be aware of their increased risk for this rare adverse event.

Who developed the Moderna COVID-19 vaccine?

The vaccine has been developed by Moderna, in Cambridge, Massachusetts, and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health.

Are the Moderna or Pfizer COVID-19 booster shots the same as the first?

If you got Moderna or Pfizer for your first dose: Moderna’s booster dose will be half of its original dosing, while Pfizer’s booster shot is the same as the initial doses.

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

The most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Side effects typically started within two days of vaccination and resolved 1-2 day later.

Can I get the COVID-19 vaccine if I have an underlying condition?

People with underlying medical conditions can receive a COVID-19 vaccine as long as they have not had an immediate or severe allergic reaction to a COVID-19 vaccine or to any of the ingredients in the vaccine. Learn more about vaccination considerations for people with underlying medical conditions. Vaccination is an important consideration for adults of any age with certain underlying medical conditions because they are at increased risk for severe illness from COVID-19.

Is the COVID-19 vaccine safe for people with underlying health conditions?

Clinical trials show that COVID-19 vaccines are safe and effective in people with underlying medical conditions, including those that place them at increased risk for severe COVID-19 symptoms, compared to people without underlying medical conditions.

Should you get the Covid vaccine if you have an autoimmune disease?

The American College of Rheumatology COVID-19 Vaccine Clinical Guidance recommends that people with autoimmune and inflammatory rheumatic disease (which includes lupus) get the vaccine unless they have an allergy to an ingredient in the vaccine.

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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Is the Pfizer-BioNTech COVID-19 vaccine authorized?

Pfizer-BioNTech COVID-19 Vaccine is authorized to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

When did the FDA issue an Emergency Use Authorization (EUA) for the COVID-19 vaccines?

On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 Vaccine. On December 18, 2020, the FDA issued an EUA for the use of the Moderna COVID-19 Vaccine. And on February 27, 2021 the FDA issued an EUA for the use of the Janssen COVID-19 Vaccine. The issuance of an EUA is different than an FDA approval (licensure) of a vaccine.

Are the Moderna or Pfizer COVID-19 booster shots the same as the first?

If you got Moderna or Pfizer for your first dose: Moderna’s booster dose will be half of its original dosing, while Pfizer’s booster shot is the same as the initial doses.

Can you get a Pfizer COVID-19 booster after Moderna vaccine?

Yes. The F.D.A. has updated its authorizations to allow medical providers to boost people with a different vaccine than the one they initially received, a strategy known as “mix and match.” Whether you received Moderna, Johnson & Johnson or Pfizer-BioNTech, you may receive a booster of any other vaccine.

Is it safe to take a different COVID-19 booster shot?

The study found that boosting with a different vaccine is safe, and that boosters increased antibody levels no matter the combination.

Are the Moderna or Pfizer COVID-19 booster shots the same as the first?

If you got Moderna or Pfizer for your first dose: Moderna’s booster dose will be half of its original dosing, while Pfizer’s booster shot is the same as the initial doses.

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.

What are the some common side effects of the third Covid shot?

So far, reactions reported after the third mRNA dose were similar to that of the two-dose series: fatigue and pain at injection site were the most commonly reported side effects, and overall, most symptoms were mild to moderate.

When do you have side effects from the Johnson & Johnson’s COVID-19 vaccine?

These side effects usually start within a day or two of getting the vaccine. Side effects might affect the ability to do daily activities, but they usually go away in a few days.

What are the ingredients in the Janssen COVID-19 vaccine?

The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.

Can Johnson and Johnson COVID-19 vaccine cause blood clots?

The FDA updated the J&J Janssen vaccine EUA with an additional warning, noting that “women under 50 should be made aware of a rare risk of blood clots and low platelets following vaccination,” said Dr. Fryhofer. “They also need to know there are other COVID vaccines out there that don’t pose this small risk.

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