The F.D.A. grants full approval to the Pfizer-BioNTech Covid-19 vaccine

[MikePal]

Well it's official:

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

[impact]

Again, this is a spin on fake news. It still continues to be Emergency Use Authorization and can be withdrawn at a moments notice. It is simply a re-issue.
Those darn pesky MSM. The devil is in the details.
Here is the actual FDA document.

Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021

https://www.fda.gov/media/150386/download


"On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication anduses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA."

[MikePal]

Your right !!....according to that document it's just a renewal for it's continued Emergency Use
Authorization (EUA).

The MSM is all over this saying they have lifted the EAU..and it's now fully approved.

however:

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.

Nice catch ..thanks !!

[MikePal]

Found some clarification..

On August 23, 2021, the FDA approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty (koe-mir’-na-tee), for the prevention of the disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for people 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

This is from the FDA document :

https://www.fda.gov/emergency-prepar...sked-questions

It sounds like the FDA has given the approval to market a 'new' Covid vaccine called Comirnaty and has re-renewed or extended the EAU for the original vaccine until it can be manufactured and distributed under the new label.

That will be our Fall shot

[impact]

You are correct Mike. On the one hand they continue the EUA and on the other there is now an FDA approved vaccine.
As usual, let the buyer beware.....lol
Here is the press release:

https://www.fda.gov/news-events/pres...VID-19-Vaccine

"Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks."

[impact]

See how this works?

[fishfood]

See how this works?

That video is false

Your are 7 percent less likely to catch the virus with natural immunity vs the shot .

Sent from my CLT-L04 using Tapatalk

[MikePal]

In case you wondering: origins of the word: Comirnaty pronounced : Koe-mir'-na-tee.

According to Pfizer, the pharmaceutical companies wanted to emphasize COVID immunization and the vaccine's core mRNA technology. They also wanted to encompass "community" and "immunity" into the final product.

Comirnaty touches all of the bases.

The name "represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency – and with safety at the forefront – during this global pandemic," Pfizer and BioNTech said.

[impact]

Browsing the Health Canada website there are a number of products available to combat covid.
Why the big push?

"Sotrovimab is indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19),
confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older
weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death."

https://www.canada.ca/en/health-cana...lications.html

[canadaman30]

Some actual facts our MSM doesn't want you to know