FDA is ordered to produce 1 million more pages of Pfizer's Biologics License Application for covid injections

Chemistry Manufacturing Controls documentation has not been produced yet. I hope it will be now. Does it even exist?

This is a quick post to let my readers know that the FDA has been ordered to produce 1 million additional pages from Pfizer’s dossier. The case is litigated by Aaron Siri, and my congratulations to him for this win!

This is the data that the FDA supposedly relied on to issue a [fake] Biologics License Approval (BLA) for Pfizer’s original “Wuhan variant” covid shot. That version of the shots has since been removed from the market, and replaced with new versions without any clinical trials whatsoever.

It has been my position that the BLA is fake because the “EUA Countermeasure” regulatory pathway is non-investigational, making it impossible to conduct clinical investigations, i.e. legally protected human experiments. Thus, it is akin a train track or a bridge to nowhere. More about this issue in the posts below.

I have been advocating for nullifying this very bad law that authorizes unregulated poison to be made “available” and pushed via mandates, coercion, threats and propaganda onto unsuspecting public. I have been advocating for removing the entire Chapter 564 that pretends to “regulate” EUAs from the Food, Drugs and Cosmetics Act.

I previously wrote about this case, and provided a solicited opinion to The Defender/CHD publication:

Excerpt from the article linked above, explaining the critical importance of the Chemistry Manufacturing Controls documentation.

I published several in-depth analyses dealing with the scientific and regulatory fraud that was uncovered, specifically the review of non-clinical study package which showed that the product had several mechanisms of severe toxicity, and that it was damaging to the reproductive function. This review also showed that Pfizer, with complicity from the FDA, committed numerous scientific and regulatory fraud, passing irrelevant studies, omitting necessary studies, and using improper study designs to obfuscate potential for great harm:

Did Pfizer Perform Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies?

Sasha Latypova

·

January 1, 2023

Read full story

Every month I inquired with my colleagues whether anything looking like Chemistry Manufacturing Controls (CMC) documentation was produced among these pages. No such materials have been included in the 1.2 million pages produced to date. The reason I was interested in that documentation is because many of us have also seen the package of CMC review materials that was leaked from the European Medicine’s Agency (EMA) in December 2020. I and several other colleagues published extensively on the woefully inadequate state of manufacturing at the time when the shots were deployed commercially world-wide. The senior staff at the EMA were stating in internal communications right around the initial commercial launch that “CMC issues” were going to be “the difficult bit”. Importantly, they are saying that the FDA told them this, i.e. the knowledge of the CMC problems originated at the FDA:

The CMC document, the so-called “Rolling Review” was also leaked and I and several other colleagues read it. It was a complete mess: the manufacturing process was incomplete, many parts of the submission dealing with critical quality control steps and analytical processes were missing entirely, or were incomplete, or were found outright fakes.

For example, Western blots were fake computer generated images, and the DNA plasmid map did not disclose the SV40 promoter, which was later found in every batch by Kevin McKernan and other colleagues.

Broken Bioweapon

Sasha Latypova

·

January 30, 2023

Read full story

As of late November, the EMA reviewers raised 140+ formal objections to Pfizer’s CMC submission, which still had many gaping holes and missing information. For reference 10-15 regulatory objections normally stop a pharmaceutical application from going forward until objections are resolved. Three Major Objections, i.e. formal red flags are discussed specifically in the emails below. I and others wrote extensively about MO#2 (lack of mRNA integrity). Here is an email from one of the reviewers, Evdokia Korakianiti and a response from Alexis Nolte discussing the problem and the impact (completely unknown and potentially very troubling) on the efficacy and safety of the product (this is when the now infamous Process 1 v Process 2 switch was identified):

It is evident from the responses to the concerns raised by Evdokia Korakianiti the EMA management waived arms and relied on “data that only FDA has seen”, but is “optimistic” and that FDA claimed mRNA breakage was a “theoretical concern”. Really?

Here are the emails indicating that the Major Objections were formally written up and subsequently disregarded by the EMA since the product was shipped commercially just a couple of weeks later.

The conditions stipulated by the EMA’s Conditional Marketing Approval were never fulfilled.

Art for today: Portrait in watercolor, 12x16 in.