Are the available Pfizer shots really FDA approved?

Comarity

Say, Where Is That Biden Regulation on Vaccine Mandates?

Answer: it doesn’t exist

 

FDA has approved the Pfizer vaccine which prompted the mandates for government employees, including the military.

Now. as I read the announcement on the FDA website, the approved vaccine is Comirarty.

STN: 125742
Proper Name: COVID-19 Vaccine, mRNA
Tradename: Comirnaty
Manufacturer: BioNTech Manufacturing GmbH
Indication:

  • Comirnaty is a vaccine indicated for active immunization 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.

Product Information

  • Package Insert – Comirnaty
  • Demographic Subgroup Information – COVID-19 Vaccine, mRNA (COMIRNATY)
    Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

 

When I read the reference on Daily Med. it says Pfizer does not plan to immediately produce any of this product!

DailyMed Announcements

Posted: September 13, 2021

Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.

What does that mean legally?

In my humble opinion, that means that anyone mandating the vaccine is legally liable, as well as anyone administering it without full disclosure – especially since the product label insert is intentionally blank, which would never pass any FDA regulation.

What do I mean by legally liable? How about violating the Nuremberg Code and the US Constitution? Does anyone remember doctors taking the Hippocratic Oath?

I am not alone here!

Sidney Powell Suing Defense Department Over “Unlawful and “Unconstitutional” Vaccine Mandates

Powell’s Texas-based group Defending the Republic announced Wednesday that it had filed a lawsuit against Defense Secretary Lloyd Austin on behalf of 16 active-duty service members “in support of their right to refuse” the coronavirus vaccine.

“Through the filing of this lawsuit, we make clear that these service members — those who serve their country with honor — are not the property of the U.S. government, and the Constitution does not allow them to be treated as such,” the group said on its website.

The complaint was first reported by Bloomberg News on Thursday.

The Pentagon mandated all service members to receive the COVID-19 vaccine in late August, immediately after the Food and Drug Administration (FDA) approved the vaccine manufactured by Pfizer and BioNTech.

On Monday, the Pentagon said its 700,000 civilian employees will have to be fully vaccinated by Nov. 22.

Airlines Covering Up Walkouts Due To Vaccine Mandate As Flights Cancelled Across America

What about Medical personnel being fired for not taking the jab, being replaced by National Guard for whom taking the jab is not yet compulsory? Are these not the same folks who have been hailed as heroes for 2020 and 2021?

Meanwhile a Pfizer exec is caught on tape admitting that probably over 200 million Americans have had Covid and their immunity in now far superior to any that would be provided by the vaccine, and we are still pushing this shot?

Are you awake yet?

This is not about science

This is not about health

This is about control!

It appears that the cup of iniquity is full and that God will soon pour out his wrath on the evil-doers!

God Bless America!

Blessings

Ron, the Watchman