THE PFIZER VACCINE, “A NEW BIOLOGICAL ENTITY”

Superb article from Jo Blogs highlights the international scale of the vaccine agenda and the role of the media in silencing questioners and opposition. MH

by Jo Blogs Red Sky In The Morning

On the day Jacinda Ardern announced that the Pfizer vaccine had now been approved for use in New Zealand, TV One news ran this news item : Misinformation a ‘threat’ as Government prepares for Covid-19 vaccine rollout.

Out came the labels and the tropes for those who are against the government’s program of immunisation. People opposed were described in negative terms, as “vaccine deniers” spreading “fake news.” No questions were asked as to the safety of the vaccines. I didn’t see Medsafe being questioned.

“We need to engage with information critically, not simply accept it because it happens to confirm what we already believe, or reject it because it challenges what we believe,” Media literacy expert Damaso Reyes said on that item.

I agree, and I’d love to ask our media and leaders taking us down this strange GM vaccine path how it applies to them? It goes both ways. People aren’t stupid, they know when something is wrong. The government and media want us to believe the vaccine is safe. Is it?

The Australian Report Card

Here’s the information on the vaccine that I found. I couldn’t find the information I needed from Medsafe, so I looked on the Australian Dept of Health’s site to see what they’re doing, as they’re also getting the Pfizer vaccine.

Report: Australian Government Dept of Health and Aging
Therapeutic Goods Administration
https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.docx

I recommend you download the document and read it. The product submission on page 7-8 describes the vaccine as a “new biological entity.”

The active ingredient is modified RNA. The product name is Comirnaty. Note, the vaccine only has provisional approval. “The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.”

The document states that “as a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration.” The Black Triangle Scheme is for adverse event reporting to help the TGA build a full picture regarding new medicines.

The footnote on page 9 states, “as part of the Department of Health’s response to the pandemic, the TGA has agreed to accept rolling data for COVID-19 vaccines, to enable early evaluation of data as it comes to hand.”

So the vaccine is still being developed even as it is being administered.

Page 16,17 describes Study C4591001. The study was done on 43,252 participants.

The Clinical evaluator’s recommendation on page 30 is the clincher : “From a clinical point of view, the relevant data is limited to a single pivotal clinical trial, Study C4591001, for which interim findings for a median follow up period of around 2 months only are available. Short follow up duration limits the conclusion on persistence of efficacy and late onset/rare adverse events. This study is planned to continue for a total of 24 months.”

The data limitations on page 34 are a real eye opener:

“In addition to the unknown longer term safety and unknown duration of vaccine protection, there are other limitations with the submitted data. The following questions have not yet been addressed:
Vaccine efficacy against asymptomatic infection and viral transmission.
The concomitant use of this vaccine with other vaccines.
Vaccine data in pregnant women and lactating mothers.
Vaccine efficacy and safety in immunocompromised individuals.
Vaccine efficacy and safety in paediatric subjects (< 16 years old).
A correlate of protection has yet to be established. The vaccine immunogenicity cannot be considered and used as the surrogate for vaccine protective efficacy at this stage.
Although the vaccine efficacies against certain outcomes have been demonstrated in the pivotal study, the real world vaccine effectiveness when this vaccine is rolled out to a larger and more diverse population is not known.”

REPORT: AUSTRALIAN GOVERNMENT DEPT OF HEALTH AND AGING
THERAPEUTIC GOODS ADMINISTRATION
HTTPS://WWW.TGA.GOV.AU/SITES/DEFAULT/FILES/AUSPAR-BNT162B2-MRNA-210125.DOCX

To sum up, you will be getting injected with something that is a “new biological entity” as the active ingredient is modified RNA and it only has provisional approval in Australia and NZ. In Australia, for the duration of its provisional registration this medicine will remain in the Black Triangle Scheme for adverse event reporing. The product you will be injected with has only had a single pivotal clinical trial, for which interim findings for a period of two months data are available.

There are questions that have not been addressed. It’s only been tested on 43,252 participants against certain outcomes. The real world vaccine effectiveness when this vaccine is rolled out to a larger and more diverse population is not known.

What do you think about being vaccinated after reading these results? Do you still trust the vaccine, government or media?

Notes:

Like Australia, Medsafe is allowing pharmaceutical companies to make rolling applications for COVID-19 vaccines. Medsafe explains the process here, it’s approving the vaccine while still in development : Vaccine Evaluation and Approval Process. They justify it by saying that due to the ongoing pandemic, there is an urgent clinical need for safe and effective vaccines to protect New Zealanders against COVID-19. 

The Australian govenment Therapeutic Goods gave it a poisons exemption. That’s interesting.

Despite the contents of the report, on Monday 25th Jan, the Guardian reported, “The Pfizer vaccine has met strict standards for safety, quality and efficacy, a statement from the prime minister’s office said on Monday, and the vaccine has been approved for rollout in Australia for people aged 16 years and older.” The Guardian

Links:

The Pfizer vaccine is to be rolled out in New Zealand, Australia, Belgium, Canada, Costa Rica, The Czech Republic, Greece, Hungary, Israel, Mexico, Oman, Poland, Qatar, Kuwait, Serbia, Slovakia, Switzerland, United Arab Emirates, United Kingdom, the US where more than a million people received the vaccine.

United States

A man called Pfizer’s direct number and was told that the vaccine has not been approved by the FDA and is licensed for emergency use only

Israel

‘There is a race to get the public vaccinated, so we are willing to take more risk.’

THE JERUSALEM POST : COULD MRNA COVID-19 VACCINES BE DANGEROUS IN THE LONG-TERM?

Helsinki Committee to declare Pfizer performing unauthorized human experiment in Israel.

Committee in charge of supervising human trials expected to state vaccine campaign is clinical study and needed pre-approval.

Senior Israel Democracy Institute attorney Dr. Tehila Schwartz-Altshuler told Calcalist:“Anyone who might claim this is not a clinical study is simply a liar. This is the most extensive study of human beings in the 21st century. Israel is becoming the experimental field, not to mention the backyard for the whole world. It may be a beautiful and altruistic thing, but this should have been shared with the citizens of Israel.”

ISRAEL NATIONAL NEWS

India

Pfizer bails out of India after country demands safety testing for COVID vaccine

And finally, here’s an evidence review of the vaccine from Penn Medicine Center.

ADVERSE EFFECTS OF MESSENGER RNA VACCINES
An Evidence Review from the Penn Medicine Center for Evidence-based Practice
December 2020

ADVERSE EFFECTS OF MESSENGER RNA VACCINES
An Evidence Review from the Penn Medicine Center for Evidence-based Practice
December 2020
Project director:…………………….. Nikhil K. Mull, MD (CEP)
Lead analyst: ……………………….. Matthew D. Mitchell, PhD (CEP)
Clinical review:………………………Patrick J. Brennan, MD. (CMO)

EVIDENCE SUMMARY
There are no specific guidelines for use of messenger RNA (mRNA) vaccines or contraindications to mRNA vaccines.
No large trials of any mRNA vaccine have been completed yet.
The only evidence on safety of mRNA vaccines comes from small phase I and phase II trials of SARS-CoV-2 vaccines, with
follow-up typically less than two months.
Systemic adverse events such as fatigue, muscle aches, headache, and chills are common.
Severe systemic adverse events were reported by 5 to 10 percent of trial subjects.
Localized adverse events such as pain at the injection side are common.
Both systemic and local adverse events usually are resolved within one or two days.
The rate and severity of adverse events appears to be higher for the second dose of vaccine than for the first.
Higher vaccine doses appear to increase the rate and severity of adverse events.
Larger trials of SARS-CoV-2 vaccines are in progress, with results expected in mid-2021.
There is not sufficient evidence to support any conclusions on the comparative safety of different mRNA vaccines.
Direct evidence on the comparative safety of mRNA vaccines and other vaccines is lacking.

http://www.uphs.upenn.edu/cep/COVID/mRNA%20vaccine%20review%20final.pdf

Jo-Blogs

NZ

Hi, I live in beautiful New Zealand. I write, I blog, I work, and in my time off I enjoy the great outdoors. I am the mother of two grown children and inheritor of their cats. I work in IT with my husband and son.