Tag Archives: approval

The NZ Govt knew in February ’21 that safety and efficacy info for the Pfizer VX was inadequate yet STILL declared it ‘safe & effective’

From NZ Lawyer Sue Grey:

Here in an extract from an information dump by Ministry of Health. Turns out they knew in Feb 2021 the safety and efficacy information was inadequate for approval of the PfizerVax. Despite this the govt declared it was “approved” and “safe and effective”.

RELATED (from the NZ Doctors nzdsos.com website):
https://nzdsos.com/2021/07/22/deaf-to-the-deaths/

Photo: FB screenshot

Important info on the CV VX fast track approval for your children

From The Health Forum NZ fb page

With the vaccination of our NZ children looming, you might be interested to see how “exceptional circumstances” allow for the fast tracking of the Covid 19 vaccine for children. I recommend you read this after you have had a few alcoholic beverages, or doused yourself in lavender oil.

FDA vs. CDC and the adolescent vaccine

The Pfizer vaccine is now authorized, by the FDA, for emergency use among people aged 12+. In other words, you could go right now and get a vaccine in your 12 year old’s arm (dependent on your state and physician, I’ll get to that in a little). However, the CDC advisory board (called ACIP) has yet to meet (they are meeting Wednesday; here is the agenda). So, what’s going on?
In normal times…
A vaccine sponsor (like Pfizer) would collect at least 6 months of follow-up data from Phase III clinical trials and submit an extensive application to the FDA. Then, the FDA would have 10 months to review, approve, and license. During this time it’s federally mandated that an external review board for the FDA (called VRBPAC) has a meeting. This is where we (the public) get to see the clinical trial data for the first time (hundreds and hundreds of pages). VRBPAC provides a formal recommendation to the FDA.

Then an external committee for the CDC (called ACIP) offers a second recommendation. The CDC Director has to ratify the ACIP decision.
The CDC typically needs to approve for three reasons:
1. Insurance to cover the vaccine
2. Government funds to be adjudicated to pay for the vaccine for uninsured kids (called the Vaccines for Children program)
3. CDC handles the logistics for delivery of vaccine, so they have to formally approve what they are distributing.

In abnormal times…If there’s a pandemic or global emergency, a sponsor can apply for an Emergency Use Authorization (EUA). The sponsor only needs 2 months of follow-up clinical trial data to apply. Then, the rest of the process is basically the same. When a sponsor applies for a EUA, it’s under the assumption that the sponsor will apply for a full license once they have the follow-up data (showing vaccine longevity, continued safety) and necessary documents (like manufacturing processes). Then the FDA has 6-10 months to review. This is where the adult Pfizer vaccine is right now.

But this is abnormal times…
The adolescent vaccine is NOT a new EUA; it’s an extension or an amendment of the adult EUA. So, the FDA doesn’t require a VRBPAC meeting. The FDA internally reviewed data and deemed it safe and effective for emergency use (which led to today’s announcement).
The ACIP meets Wednesday, which is basically a formality. Importantly, though, we (the public) will get to see some data. In some states, only pediatricians can give vaccines to kiddos (not pharmacies). Also, a LOT of physicians will still wait for the ACIP recommendation. So, this CDC meeting is still an important step.
Bottom line: The Pfizer vaccine is officially authorized for patients. We will still get a lot of new and important information on Wednesday.
I hope I didn’t make this already confusing process even more confusing.
Love, YLEData sources on my newsletter here: https://yourlocalepidemiologist.substack.com/…/fda-vs…Post reproduced from
https://www.facebook.com/profile.php?id=100053149454347

Criminal FDA Authorizes Emergency Use for Pfizer’s mRNA Injections on 12-15 Year-olds – Up to State Governors to Save the Nation’s Children

by Brian Shilhavy
Editor, Health Impact News

As expected, the FDA granted emergency use authorization to Pfizer’s experimental COVID mRNA shots to be injected into children between the ages of 12 and 15 today.

The FDA is a criminal organization comprised of medical professionals with ties to Big Pharma who are serving the pharmaceutical industry, and not the public.

None of the COVID-19 injections given emergency use authorization were done so legally. Many scientists and doctors have protested, and even filed official complaints against the FDA, because there are already effective treatments for COVID-19, making an emergency use authorization unnecessary.

In addition, the current injections for COVID-19 do not meet the legal definition of a “vaccine,” but are an entirely new class of injections that inject an operating system into your body and works directly with your DNA. See:

Moderna’s Top Scientist on mRNA Technology in COVID Shots: “We are Actually Hacking the Software of Life”

Many young people aged 16 to their early 20s have already died and been seriously injured following the Pfizer injections, and we have covered their stories here on Health Impact News.

READ MORE

https://healthimpactnews.com/2021/criminal-fda-authorizes-emergency-use-for-pfizers-mrna-injections-on-12-15-year-olds-up-to-state-governors-to-save-the-nations-children/

Photo: healthimpactnews.com

Sue Grey takes on the NZ govt over Covid rollout (commentary from Tribe of Kiwis)

From Tribe of Kiwis YT channel

Tribe of Kiwis

Voices For Freedom article (2 Apr 2021) “Who Cares If It’s Not The Law?” – with a preview of many of the source materials as the reading progresses. All SOURCES and LINKS are in the Show Notes below (click on “SHOW MORE”)

Time Stamps

0:00​ Intro
0:16​ Reading
0:51​ The Letter
2:04​ 1. The Approval Process
3:47​ 2. Marketing the Pfizer Vaccine
8:28​ 3. Administration of Pfizer Vaccine
9:45​ Informed Consent
11:15​ Remedies Sought
12:27​ So Who Does Care?
15:56​ What’s next?
16:29​ Outro

All SOURCES: More Information and Credits: See the SHOW NOTES: https://docs.google.com/document/d/1N…​ COPYRIGHT CREDITS (in video order) and thanks to: SOURCE TEXT for reading: Voices For Freedom (2 Apr 2021) “Who cares if it’s not the law? Why holding our government officials to account matters.” https://voicesforfreedom.co.nz/who-ca…​ The source article is responding to Sue Grey’s letter of 31 Mar 2021, published here: https://www.outdoorsparty.co.nz/sue-g…​ See further related materials in the SHOW NOTES – link above. “FAIR USE” VIDEO & SOUND clips These are used for the purposes of education, discussion and commentary: – NZ PM, VIDEO: speaking to a Press Conference (published 15 May 2020) https://youtu.be/ENEUktOrQV8​ Jacinda Ardern – “We will continue to be your single source of truth. Otherwise, dismiss anything else.” – NZ PM VIDEO: Jacinda Ardern speaking to a Press Conference (published 1 Mar 2021) https://youtu.be/nqEVtGrluaA​ Talks about using “sustained propaganda”. LICENCED CLIPS: “Sunrise” video – Bellergy (Pixabay licence) In Intro & Outro: “The Last Days” Lyrics, music and performance © S Stevenson (with permission) A PETITION to the NZ PARLIAMENT was earlier promoted on this channel on the topic of “Informed Consent” re the vaccine. https://youtu.be/O–hz53ACVo​ Petition request: (300 character max) “That the House of Representatives urge the Government to ensure that the use of any coronavirus vaccine is voluntary in New Zealand and that no coercion will be applied to NZers from Government or private entities to take it.” The petition ran until 5 Nov 2020 and received 5,000+ signatures. A detailed SUPPORTING DOCUMENT was provided to the petition site, but could not be linked to the petition as no space is provided for evidential support on the government website. You can access (and download) that document here: https://docs.google.com/document/d/14…​ Ep 4 of the Tribe of Kiwis series “Is the NZ Government Manufacturing Consent?” was also on the topic of Informed Consent in NZ, focusing on the Nuremberg Code and the official Guidelines for the Public Service Commission. See here: https://youtu.be/S9ai4NasMPE​ SUBSCRIBE for an alert for the next episode in the series. Tribe of Kiwis is a place for conversation about things that matter to ordinary Kiwis – people who want to consider and share information important to our shared future …… and that of our children and grandchildren. Email: tribe.of.kiwis@gmail.com

A NZ lawyer asks: how did Cabinet get lawfully from Medsafe’s Provisional approval with 58 conditions on 3 Feb 2021, to fully adopting Pfizer’s experimental mRNA injection JUST A WEEK later?

Sue Grey

LLB(Hons), BSc, RSHDipPHI and specialist in emerging issues.

“I’m still trying to understand how Cabinet could lawfully have got from Medsafe’s Provisional approval with 58 conditions- on 3 Feb 2021, to fully adopting Pfizer’s experimental mRNA injection known as Comirnaty just a week later. Has anyone seen the advice given to Cabinet, who prepared it, or the reasons for their decision?” https://insidegovernment.co.nz/pfizer-vaccine-approved…/

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