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After almost nine months under an emergency use authorization, the Pfizer-BioNTech COVID-19 vaccine earned full approval from the U.S. Food and Drug Administration. 

The vaccine now will be marketed as Comirnaty, the FDA announced Monday, Aug. 23. It is the only vaccine of the three granted emergency use authorization to receive full approval. The other two are Moderna and Johnson & Johnson.  

The FDA issued the emergency use authorization for the Pfizer vaccine on Dec. 11, 2020. The vaccine is still available under emergency use authorization for youths 12 to 15 years old and as a third-dose booster for certain immunocompromised people.

The approval could encourage people who were hesitant to now get the vaccine, according to a June 30 Kaiser Family Foundation vaccine monitor survey. Thirty-one percent of unvaccinated adults said they would be more likely to be vaccinated if fully authorized vaccines were available, according to the study.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said acting FDA Commissioner Dr. Janet Woodcock. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

All three of the vaccines have met “rigorous, scientific standards for emergency use authorization,” Woodcock continued. 

The effectiveness and safety of the Comirnaty vaccine was evaluated among 22,000 people who received the vaccine and 22,000 who got the placebo.

The FDA determined the Comirnaty vaccine was 91 percent effective in preventing COVID-19. The administration reported some common side effects were redness and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, and fever.

The vaccine as administered under the Pfizer name, according to the FDA, does increase the risk of myocarditis (inflammation of heart muscle) and pericarditis (inflammation of membrane enclosing the heart) in some individuals, with the highest observed risk in males 12 to 17 years of age. The FDA review found that most individuals who have those side affects recover, although a few required intensive care support. 

Comirnaty is the same formulation as the Pfizer vaccine that was initially granted an emergency use authorization and is administered with two doses given three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.” 

10 thoughts on “Pfizer vaccine now fully approved

  1. When will they encourage Vitamin D, Vitamin C, Zinc, and a healthy lifestyle coupled with clean healthy eating of vegetables and good foods, and daily exercise instead of a vax to help fight this?

    1. Those things aren’t bad, but neither are vaccines. It’s not an either/or situation.

      1. I want to build on this point, if I may. All of the things mentioned by “A” are essential to a healthy lifestyle, and it’s no secret that health can drastically improve with a bit more discipline and focus on these things. He or she is absolutely right. This can drastically reduce common illnesses and even built the immune system to push through more serious illnesses and disease.

        However, I also support John’s point of view. It’s not an either/or. There are times for medicine and/or vaccines, and this is one of them. The fact that Covid is a novel coronavirus means that it was introduced to mankind and spread rapidly due to us not having natural immunity to it. Hence the need for a vaccine. Not to mention, vaccines have a significant place in history by eradicating things like polio and several other very serious conditions. Covid is no different.

        Both of you are right, in part. Let’s not argue about it or be petty in our responses, please.

  2. Mind your own business. You’re likely to spread it as anyone.

    1. I pray that you don’t have anyone near you have to get hospitalized. I’ve lost two family members and my nephew (12 years old) is currently in the ICU. Having large scale vaccinations in our society is imperative to stop the spread. People deliberately refusing to acknowledge science and medical professional and others spreading misinformation are a big part of the problem. Society’s response to this is everyone’s business.

    2. Exactly! This is precisely why more people need to be vaccinated. It’s not that complicated.

  3. I agree! The CDC has designated Burnet County as having a High rate of virus transmission, which is the worst rating.

  4. Getting more folks vaccinated is the most reliable way to prevent the spread, especially to those with the greatest risk. My sincere hope is that people will see the FDA’s approval in a positive light if they’re currently on the fence. Friends, please do get your vaccine if you have not yet received one. The time is now. Thanks!

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