EMA Leaks: Pfizer's CEO Lied To The FDA

And health regulators preplanned acceptance dates despite knowing flaws

In the section of documents dealing with the emails, an image (“13.png”) showing supposedly an excerpt from an email is shown from a ‘Marco’ who works at the EMA, talks about their interactions with the FDA

[Update: A Daily Beagle reader has told us it is most likely Marco Cavaleri, who is Head of Biological Health Threats and Vaccines Strategy at the EMA.]

In the apparently screenshot wording, ‘Marco’ mentions that ‘misleading messages’ were occuring, where the FDA were falsely told by the CEO of Pfizer — Albert Bourla — that the EMA wanted the data from the FDA sooner. The EMA had agreed with the FDA to maintain closer communications to avoid ‘misleading messages’ (read: lies) from the CEO.

If true, this would mean Pfizer’s CEO not only lied, but engaged in criminal activities by misleading a healthcare regulator with fraud in attempt to rush their product through even faster.

The image transcribed:

Few highly confidential news after talking with FDA:

Pfizer:

- they need to sort out CMC aspects which will require a bit of time

- They are in negotiation with Pfizer to postpone submission for EUA until end of NOV (planned NOV 21).

- Mature efficacy data will be ready likely beg of DEC (earlier than expected)

- FDA may target an AC 18 DEC for issuing EUA before end of the year

- we agreed to keep channels open and share views so to avoid misleading messages going through (Pfizer CEO lobbied Peter Marks telling him EMA wants the data earlier!!)

- we may discuss together with FDA (and HC) the CMC package once ready

- we concurred that a conclusion roughly at the same time, if at all possible, would be fantastic

Moderna:

-they plan to submit EUA application end of NOV and could follow a similar pattern or even faster as CMC seems to more straight forward

-for us this may take a bit longer but colleagues are pushing hard to compress review timeframe

Can tell you more at tomorrow's SG

Marco

EUA is Emergency Use Authorisation. FDA is Food and Drug Administration. EMA is the European Medicines Agency. HC means Health Canada. CMC likely means Chemistry, Manufacturing and Control, which is a term used in Europe.

Peter Marks is the director for the Center for Biologics Evaluation and Research (CBER) at the FDA. The shots are known as ‘biologics’, as they contain biological materials. Supposedly Peter Marks job is to oversee the review of the product rather than receive intense lobbying from the CEO of Pfizer.

Preplanned Acceptance

What’s interesting is the document basically shows despite the evident flaws in the Pfizer shot, the FDA, EMA and Health Canada were all basically preplanning to accept the shot — regardless of whatever objections the public or external healthcare professionals might have raised about it.

EMA tell Pfizer to delay submission for EUA, essentially helping them to game the system and bypass any flagging of defects with the product that would prevent the EUA from succeeding. Health regulators in bed with the pharmaceutical companies.

And, not only did they preplan acceptance, they were attempting to synchronise their acceptance dates. The health regulators were clearly engaging in fraud, because they weren’t truly reviewing the product, they were trying to rush it though.

Preplanning Acceptance And Indepedent Review Are Mutually Exclusive

To set a preplanned acceptance date would be to suggest they somehow can foresee the future and know in advance how soon an issue will be rectified.

The comments come with the backdrop of the obviously unstable mRNA and truncation of transcripts, besides other issues, found with the shots, but somehow they act as if a solution has already been found, even though it hasn’t, and none of them are inclined to disclose how the issue was rectified (likely because in reality, it wasn’t).

[…] colleagues are pushing hard to compress review timeframe […]

This shows the review wasn’t truly independent, as they weren’t looking to expose flaws, improve the product, and wait until it was safe for public use, but were willing to criminally endanger the public by forcing through specific, fixed dates.

---

Subscribe to The Daily Beagle to get more content.

Learned something new? Think others could learn?

And leave a comment below: