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FDA approval of Comirnaty.


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  • Platinum Contributing Member

Dr. Robert Malone (one of the inventors of mRNA technology) is saying that Comirnaty is not available in the US and basically they are using its full approval to get people to take the other mRNA vaccines.   Now he admitted that it is similar but still not the same.   He claims Comirnaty will not carry the immunity protection the EUA vaccines do.

From the FDA website.  Seems a bit strange if the formulation is interchangeable why both wouldn't have been approved?   

https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

Will the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?

The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved.

How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?

The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.  Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.

 

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I’m really not following this anymore because I’m tired of the daily twists and turns along the way to the new goal post locations but, wasn’t Pfizer the one with the problems and shown to be the least effective compared to the J and J?

 

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  • Platinum Contributing Member
2 minutes ago, Zambroski said:

I’m really not following this anymore because I’m tired of the daily twists and turns along the way to the new goal post locations but, wasn’t Pfizer the one with the problems and shown to be the least effective compared to the J and J?

 

No, I don't think that is accurate.  Unsure on the % of problems but the Pfizer has proven to be effective.  

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43 minutes ago, Highmark said:

Dr. Robert Malone (one of the inventors of mRNA technology) is saying that Comirnaty is not available in the US and basically they are using its full approval to get people to take the other mRNA vaccines.   Now he admitted that it is similar but still not the same.   He claims Comirnaty will not carry the immunity protection the EUA vaccines do.

From the FDA website.  Seems a bit strange if the formulation is interchangeable why both wouldn't have been approved?   

https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

Will the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?

The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved.

How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?

The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.  Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.

 

Is it available at feed stores? 

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  • Platinum Contributing Member

Maybe the vaccine vials must have the actual trade name of what's approved.   Seems foolish if they are the same that everything Pfizer out there with or without Comirnaty should be considered approved.    

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40 minutes ago, ActionfigureJoe said:

Is it available at feed stores? 

You do realize that it is you and your liberal buddies taking pictures and writing articles about this, right?  Think about that really hard for a while.  Trying to push some bullshit deceptive narrative when it is actually liberals doing it.  Hypocrisy again.

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1 hour ago, Zambroski said:

I’m really not following this anymore because I’m tired of the daily twists and turns along the way to the new goal post locations but, wasn’t Pfizer the one with the problems and shown to be the least effective compared to the J and J?

 

I could be wrong but I think the AstraZeneca one was?

Many people took it up here in Canada as that is all our idiot in charge could procure. The WHO said not to mix them with other vaccines, our idiot said it was fine. Our idiot said we can go past the expiry date but the WHO and CDC said that was a stupid idea.

Many who took it have been turned back from certain countries because it is not recognized as a legit vaccine and will need to be re-vaccinated again. Our scientists said to trust them, it is perfectly safe and reliable but are now saying, we were wrong, but keep on trusting us anyways. :$

AstraZeneca recipients frustrated after being forced to cancel international travel plans.

https://www.cbc.ca/news/canada/calgary/alberta-vaccine-travel-1.6128470

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4 minutes ago, irv said:

I could be wrong but I think the AstraZeneca one was?

Many people took it up here in Canada as that is all our idiot in charge could procure. The WHO said not to mix them with other vaccines, our idiot said it was fine. Our idiot said we can go past the expiry date but the WHO and CDC said that was a stupid idea.

Many who took it have been turned back from certain countries because it is not recognized as a legit vaccine and will need to be re-vaccinated again. Our scientists said to trust them, it is perfectly safe and reliable but are now saying, we were wrong, but keep on trusting us anyways. :$

AstraZeneca recipients frustrated after being forced to cancel international travel plans.

https://www.cbc.ca/news/canada/calgary/alberta-vaccine-travel-1.6128470

Our leadership in both countries really are neat.  But their followers, I mean, these are the really special idiots for sure.

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Just now, Zambroski said:

Our leadership in both countries really are neat.  But their followers, I mean, these are the really special idiots for sure.

It's mindboggling, actually, but I get it to some extent based on what these idiots are told on the news. As you know, nothing but lie after lie from the Dem/Liberal funded news sites. 

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Just now, irv said:

It's mindboggling, actually, but I get it to some extent based on what these idiots are told on the news. As you know, nothing but lie after lie from the Dem/Liberal funded news sites. 

Keep your subjects fearful and they are easier to control.

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1 hour ago, ACE said:

I’m raw doggin this virus for everyone’s safety 

You are a great credit to yourself, your countrymen and men and women of the world who aren’t afraid of the flu!!!!

35 minutes ago, Crnr2Crnr said:

Good choice

I’m not scared of a flu.  I’m sure I’ve already contracted it, as my wife and daughter most assuredly have also.  Our bodies worked as designed.  SBYL and others like you.

Faggot.  :lol:

 

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