Transcribed by Anne Dachel

Dec 16, 2021, (Australia) Kalkine Media Explosive revelations about the FDA and Pfizer's COVID vaccine [PART 1]

The highly confidential Pfizer documents, which have been synonymous with the extreme lack of transparency revealed by the actions of pivotal governmental agencies, over the past 20 months, lead critics of the official narrative to demand “show us the data,” is finally being revealed–well sort of, the first few hundred redacted pages out of a trove of 451,000.

What led to the disclosure?

The crack in Pfizer and the Food and Drug Administration (FDA) iron dome-style data safeguarding, arrived in the form of a Freedom of Information Act (FOIA) release with the request filed on August 27, 2021, to access all the Pfizer documentation that the FDA had relied on to authorize the Pfizer-BioNTech Covid-19 vaccine for emergency use authorization. An agency that has received a FOIA request is required to ‘determine within 20 business days after the receipt of any such request whether to comply with such request,’ as set out by the 1967 FOIA law. It took the FDA though three months to release the first 91 redacted pages, on November 20.

Kalkine Media anchor, James Preston: With billions of COVID 19 shots having been mandated by various governments, the desire for more information surrounding the process of their creation and approval from governing bodies has reached fever pitch.

The FDA or Food and Drug Administration who is in charge of regulating the vaccine in the U.S. was recently hit with a freedom of information request from a group of 30 scientists and academics from across the globe wishing to get an insight into the approval process of the Pfizer vaccine.

The first 500 pages have been released from the drug manufacturer, and to talk us through the documentation is investigative journalist from TrialSite News, https://trialsitenews.com/ Sonia Elijah.

…Let’s talk about the insane response from the FDA and how long they actually want to make this information public.

Can you take us through the timeframe?

Sonia Elijah: Around August 23rd, the FDA licensed the Pfizer-BioNTech vaccine for individuals aged 16 and over. Then a large group of about 30 scientists and academics filed a Freedom of Information Act request a few days later, requesting to see all the documentation that the FDA relied on to license, to actually authorize the emergency use authorization of the vaccine.

Under FOIA law, Freedom of Information Act law, the 1967 law, an agency has up to 20 days, within 20 business days to determine whether they’re going to comply with the request.

It took the FDA, I think it was around November 20th when they did release the first batch of documents, and what they released with less than one percent of the actual documentation they have. They have up to 471,000 pages. They released just a few hundred.

They responded that they were going to release at a rate of 500 pages a month. That would take them to 2076 to release all the documentation.

They then came back and said, actually we’ve got additional pages, it’s going to take us up to 2096 to release all the information to the public. So it’s really shocking.

Preston: Given that this has been rolled out at such a large scale, we should be getting this information as soon as humanly possible, and for me, 70 years is nowhere near the kind of timeframe.

What’s the usual turnaround time for a Freedom of Information Act request?

Elijah: It’s about 20 business days that an agency determines whether to comply with the request, 20 business days.

Preston: In terms of the delivery of the actual documentation though, is that something that we can usually see for that size of information?

It’s probably not something we’ve dealt with too many times in the past in terms of the sheer volume of pages and documentation.

When we’re seeing such things as maybe like a hundred thousand pages, what’s typically the turnaround period? Is that maybe a month after that request has been lodged?

Elijah: Well I know they can do a lot better than 500 pages a month. So they’re literally at a snail pace.  They’re dragging their feet. They’re doing all they can to sort of prolong the time to do it. 

It’s really shocking. The people, you know, the public deserves to know, and the FDA needs to work a lot harder to facilitate the FOIA request.

Preston: Let’s look squarely at the first 500 pages itself. What generally is covered in this first release and what time period does it tend to focus on in terms of the approval process?

Elijah: So the analysis that I did, I targeted a specific document called The Cumulative Analysis of Post-authorization Adverse Event Reports of the Pfizer vaccine, and that covered the period from December 1, 2020, when it was given emergency use authorization, to February 28, 2021. That’s a 3 month period that we’re talking about.

There’s a lot you can actually glean from this document even though there are many unknowns. It is a redacted document, unfortunately.

Though we don’t know the number of total doses given, then we can’t calculate the incidence rate. But what we do know is that about 1,228 deaths were recorded in that three month time period.

[This] is very alarming because you have the former chief medical officer of Pfizer talking to the Washington Journal around April of this year saying that there’d been no deaths recorded directly because of the vaccine, and that no corners were cut.

That’s sort of quite shocking when we know that this document was produced—well the cutoff period was February 28th of this year.

Then we have the astounding number of adverse events. We’re talking about over 40,000 adverse events were recorded.

Not only that, so those are individual, actually—I make a mistake—40,000 individual cases, so for the individuals reporting, and then 150,000 events, meaning sort of symptoms.

In one case you could have various symptoms, three or four symptoms connected to an individual.

Preston: According to the document, how closely linked to the COVID vaccine from Pfizer are those actual adverse events?

Is there a direct correlation according to this report?

Elijah: What is interesting, because they give us some statistics, they talk about, they give us the medium value. So for a lot of these event outcomes, the median value is less than 24 hours.

So that’s from the time a person has taken that vaccine to the actual adverse event occurring is less than 24 hours.

Then you have, for example, the category of anaphylaxis, you have nine recorded deaths, and out of the nine deaths, four deaths occurred on the same day that the individuals took the vaccine. So that gives a very strong indication of vaccine death causality.

Preston: That’s a very close connection based on, especially as you say, four in the same day.

From this report as well, that I’ve seen with what you’ve done with TrialSite News, it also appears that women are actually disproportionately affected by the drug.

What can you tell us about that?

Elijah: It’s really alarming to see that literally across the board in all categories of adverse events, you’re seeing women three times more affected by these adverse events.

But what particularly stands out is the category of anaphylaxis. You have women eight times being more affected by that adverse event. That’s very alarming.

It sort of reveals there’s a gender specific vaccine safety risk going on here.

What is also very alarming is that throughout this document, Pfiser says there’s no new safety risks recorded.

So there’s like nothing new to report here. So it’s all sort of brushed under carpet.

Preston: I know one thing we’ve seen is that certainly here in Australia, there’s been a bit of hesitation from our GPs and other physicians who have suggested if you are looking to have children soon, if you are pregnant, then you shouldn’t be taking the vaccine.

What’s been the scenario over in the U.K., for example?  It that a similar situation?

Elijah:I think pregnant women are encouraged to take the vaccine here as sort of protect yourself, protect your unborn child.

It’s very concerning because in this document, there is a category called missing information…

It’s what was missing in the original package that was sent to the FDA.

What I have analyzed, what I’ve done report on, it’s sort of like an amended version of what Pfizer has given to the FDA. So they sort of include now the missing information which is to do with pregnancy and lactation.

You have adverse events happening there. You have spontaneous abortions and premature births and neonatal deaths.

Preston: Spontaneous abortions. Can you go into that in a bit more detail? What exactly does that entail? Is this pregnancies that were otherwise completely healthy until this point?

Elijah: Yes, so it’s sort of a pregnant mother having a miscarriage.  It’s very alarming.

Preston: This is sort of in that same 24 hour period? What’s the period we’re looking at for this data set?

Elijah: I’m actually just looking at, so for the pregnant—it’s quite a long report I wrote, so I don’t have the data basically for that, but I remember there were about 270 unusual pregnancies, and there were about 25 spontaneous abortions from what  I remember.

And we’re talking about a 3 month time period here, and as we know we are coming up to a year of the vaccine.

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