Recently, a judge ruled in favor of a group of experts who sued the FDA over lack of access to Pfizer COVID injection data.  Instead of the FDA’s request of 75 years to slow drip the data, the judge ordered them to release 55,000 pages per month – which would take approximately 8 months for completion. Unfortunately, the FDA will redact information that it decides is not for public consumption, which might make the data meaningless. For instance, if the FDA redacts batch numbers it will be difficult to identify which participants were harmed by which batches. If they redact ID numbers, it will be difficult to track adverse events.

https://maryannedemasi.com/publications/f/experts-weigh-in-after-suing-fda-for-access-to-pfizer-trial-data

Experts weigh in after suing FDA for access to Pfizer trial data

20 December 2021|COVID-19
COVID-19, mRNA, vaccine, Pfizer, transparency, trial data, FDA, DOJ, Aaron Siri, Aaron Kheriaty, Tom Jefferson

By Maryanne Demasi, PhD

In Dec 2020, the US drug regulator (FDA) granted emergency use authorisation to Pfizer’s Covid-19 mRNA vaccine with limited data from phase III trials.

Amid the urgency of the pandemic, the review of the trial data was conducted faster than usual. What would normally take an average of 10 months to review, only took the FDA 108 days.

Immediately, it raised doubts about the speed with which the agency made its decision.

Fast forward to Aug 2021 and the FDA granted full approval to Pfizer’s (Comirnaty) mRNA vaccine, without releasing the full data set to the public for independent scrutiny. 

Experts became concerned that all the publicly available information on a fully licensed product, was limited to journal articles, press releases, and assessments by drug regulators – all of which are subject to conflicts of interest and bias.  (See link for article)

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Highlights:

  • 80 public health officers and researchers formed an alliance to get the data.
  • The group filed a FOIA lawsuit in September due to lack of public disclosure of FDA data.
  • The placebo & therefore the control group was eliminated because the shot was offered to all.
  • The group argues that due to insufficient and hurried testing & a culture of secrecy, the idea of informed consent is arguable.
  • There has been under-reporting adverse events, falsification of data, and a lack of efficacy  regarding the Pfizer injections.
  • DOJ lawyers wanted to drip feed Pfizer data over decades (75 years in fact, which is laughable).
  • The FDA claims it is insufficiently staffed.  They have 18,000 employees and $6.5 billion in funding.

Important quote:

“It is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harm, but yet refuse to let Americans see the data underlying its licensure.” ~ Aaron Siri, US attorney acting on behalf of PHMPT

  • The first round of Pfizer’s documents has already been released by the FDA.
  • It showed 1,223 people died from the shot within the first 90 days of the rollout, but much of the document is redacted and it is unknown how many doses had been shipped out, i.e. how many total doses were given.
  • Please see top link for a telling graph of 10 months of the COVID shots vs 20 years of flu vaccines.  Shocking would be an understatement.
  • https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf  Starting on page 30, there are nearly 9 pages of single spaced adverse reactions.
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