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FDA Issues Full Approval for Pfizer, BioNTech Vaccine

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Vaccine Product Approval Process by Food and drug administration (FDA) or center of disease control (CDC) | FDA Issues Full Approval for Pfizer, BioNTech Vaccine | featured

The US Food and Drug Administration (FDA) issued its full approval to the COVID-19 vaccine developed by Pfizer and BioNTech. Their vaccine became the first coronavirus to earn the coveted status. This also means that government agencies, businesses, and institutions can be more confident in continuing their planned vaccine mandates.

RELATED: FDA Aims to Fully Approve Pfizer-BioNTech Vaccine by Sept

First COVID-19 Vaccine With Full Approval

With full approval, Pfizer and BioNTech can now market their vaccine in the United States. The companies designated the name Comirnaty for the vaccine. Reportedly, the choice of brand name is a play in the words community, mRNA, and immunity. 

Previously, all COVID-19 vaccines available right now are under the FDA’s Emergency Use Authorization. The approval, issued last December, temporarily allows government agencies to give Americans vaccine shots in light of the pandemic’s urgency.

At this point, Pfizer and BioNTech already administered more than 204 million doses. This is according to data compiled by the Centers for Disease Control and Prevention.

FDA Under Pressure to Issue Full Approval for Vaccine

With the pandemic continuing to surge, federal health officials were under pressure to issue full approval for any of the COVID-19 vaccines operating under a EUA. As early as May, Pfizer and BioNTech submitted their application for a Biologics license, which covers the use of their vaccine for patients 16 years old and up.  

However, FDA experts need to go through a trove of data before they can confidently issue an approval. This includes reading through and evaluating hundreds of thousands of pages of vaccine data from 40,000 trial participants.

During their evaluation, the FDA discovered that the vaccine’s 91% effectiveness rate is lower than its earlier claimed rate of 95%. Despite the lower effectiveness rate, Acting FDA Commissioner Janet Woodcock said in a statement that companies met the agency’s standards for “high standards for safety, effectiveness, and manufacturing quality” even during its EUA stage.

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“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,” the FDA statement said. The FDA organized a media briefing last Monday to discuss the full approval. 

Many Americans Still Hesitant

Even with the coronavirus still resurgent in the US after a year, many Americans remain hesitant about getting a vaccine. Currently, only about 60% of the total US population has at least one dose of any COVID-19 vaccine.

The rest are either adamant about not getting the vaccine or will wait for further developments before deciding.

However, a full approval status may help convince hesitant Americans of the vaccine’s safety and effectiveness. In particular, a Kaiser Family Foundation survey said that 30% of unvaccinated American adults said they would likely get a vaccine if they have the FDA’s full approval.

Full Approval Applies to 16 Years and Older Only

Despite the full approval status, the Pfizer-BioNTech vaccine only applies to Americans 16 years and older. Application of the vaccine to children between 12 to 15 years of age remains under Emergency Use Authorization.

In fact, Dr. Peter Marks, the FDA’s top vaccine regulator, said that the FDA continues to work for full approval for the age bracket once it completes the needed data. “Currently, there are still trials ongoing and so the agency has to wait for the company to submit the data for those trials. We certainly want to make sure that we get it right,” he said.

Watch the ABC News video reporting that the FDA grants full approval to Pfizer COVID-19 vaccine:

Will the FDA’s full approval convince you to take the COVID vaccine or make you recommend it to family and friends?

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Unvaccinated readers of The Capitalist, will the FDA’s full approval convince you to take a COVID-19 vaccine? For the rest, will full approval make you recommend to your friends or family to get the vaccine now?

Let us know what you think. Share your thoughts below.

16 Comments

16 Comments

  • BBA says:

    If anyone is stupid enough to trust the FDA and the CDC at this point then the jokes on you!

  • Ben says:

    None of this takes into account natural immunity. All tests done to date show full antibody effectiveness over the last 18 or more months. If you’ve had covid, there’s zero scientific reason to get the shot.

  • james R music says:

    Ive had my shots ,but every one around me that took the shot is sick with the dam viris you cant trust any to tell the truth. a lot of people are going to die this was the plan when that moron joe biden stole the election, Kill as many of the old people as possible now its the young tha is catching it.we are fucked any way we go.we need our true president in office Donald J Trump.james R music

  • Bill G says:

    selected answer says it all

  • retief says:

    Actually if you read the FDA’s letter, it says it extends the emergency use of the vaccine. Nothing about actually approving it. If it is not approved then I wont take it.

  • Lillian Tergesen says:

    The trouble is at 81 this shot may help! I don’t want to die alone in a hospital gasping for air! So, I’ll take my chances! Where would we be without the Salk vaccine, measles shot, chicken pox shot and all the other shots that help us! I just got over shingles, not fun, what, because I didn’t get my shots! My niece is in the hospital with COVID because she was afraid to get the shots because she has issues, even though the dr told her to get it, now she’s sitting up, but was told she would need oxygen the rest of her life! It was hard to watch her like that through Facebook messenger! It’s a choice! I made mine. Die gasping for air or a so call blood clot! Which is a rumor!

  • Mark Warren says:

    Full FDA approval means nothing to me; for all I know, the FDA buckled under pressure from the Government and businesses, to approve it. We cant even trust our doctors because they may be getting monetary “kick-backs”, or are yielding to either real, or perceived, pressure from colleagues, the BAR, or the Government, to push these vaccines on us.

  • Rick says:

    No don’t need it with a survival rate so high

  • Phillip/Lavergne Prejean says:

    Having taken the twosots inFeb. I have felt safe all along. Look forward to the booster when possible. Never had any side effects.

  • Patriot1776 says:

    Instinct… Survival… Keep your eyes open to what is going on behind the loosely closed curtain. The truth is being shown to all and hopefully it isn’t to late before most realize it. Freedom of choice. If you want to take the Shots, then that is your choice and if you don’t, that is also your choice. From what I have seen on the “frontline” and heard I choose to not get the shots. prepare, get ready and be sure that you can protect yourself and your family. Join in numbers, work together and stand your ground.

  • Cheryl A Miller says:

    I totally agree with Bill G. My vote says it all.

  • Richard Livengood says:

    Bill G! Totally agree!

  • Zig says:

    PRESS is lying to get more people to take the jab…
    Apparently FDA DID NOT APPROVE but… EXTENDED EMERGENCY USE of Pfizer-BioNTech COVID Vaccine!!! Read the page 2 of FDA document!!! https://www.brighteon.com/381cdea2-b878-46c9-b4e0-93e44188a225

  • Stinkbug says:

    It doesn’t matter no vaccine had been 100% this crap is no different. Ko one can force you to take it and employers can be sued

  • Skeptical says:

    ‘QUACK QUACK’ goes the doc.

    This Big Pharma shill fails to note that if any effective therapeutics are avalible instead of an injection (and there is), no mandate is justifiable. Further, emergency declarations do not suspend the Constition and its civil liberty protections, so again, no involuntary mandate. To act so in a purported medical mandate is a severe crime punishable by death, as defined by 1947 International Nuremberg treaty this country is a signatory to. Do not comply, as it may mean death or a more shorter life.

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