11 May 2022, New Delhi – A major scandal related to the Pfizer vaccine for Covid-19 and the manner in which the US Food and Drug Administration approved it for the public is in the process of erupting. In the first week of January this year, Federal judge Mark Pittman, in Texas in the United States, through his order, set off a chain of events that could cause a huge scandal related to the clinical trials and hasty approval of the Pfizer vaccine for combatting the Covid-19 pandemic.
In the first week of May, some 55,000 pages of documents relating to the clinical trials have been made public, raising eyebrows in the medical fraternity worldwide. Yesterday Twitter was literally on fire with analysts claiming and alleging that the vaccine had only 12%efficacy (as against the 95% claimed) according to Pfizer’s own documents. Many observers and experts on the net have also alleged that the documents reflect a lack of patient safety, an abject lack of transparency, and even falsified clinical trial data.
On Friday 7 January 2022, Reuters said, “A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s Covid-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.”
“That’s roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine.”
The order by the judge effectively means that the Food and Drug Administration would have to release some 55,000 pages of Pfizer-related documents every month and make public the humungous pile of files by the end of this year.
The matter came to court when a case was filed against the FDA by Public Health and Medical Professionals for Transparency (PHMPT) demanding that all documents relating to the trials and approval of the Pfizer vaccine be made available to the public. The FDA apparently pleaded it didn’t have enough staff and if it tried it would take them up to 75 years to make public all the files! The judge did not buy that argument, ordering that 10,000 pages must be made public immediately and then 55,000 pages a month till every relevant file is made public. That has started the big PFIZER DUMP.
The story began to unfold much earlier when Brook Jackson, who worked as regional director with the Ventuvia Research Group, which was conducting clinical trials for Pfizer, resigned from her job and alleged that data from the trials were being falsified. In short, she became a whistle-blower. Her detailed allegations are available on her YouTube video. The US govt and the FDA of course ignored her allegations.
In November 2021, The British Medical Journal published an article by Serena Tinari saying Jackson had made available to it internal emails and other documents related to the trial and went on to write about her allegation that data had been falsified and patient safety hugely compromised.
The recent ‘dump’ of documents relating to clinical trials has led to a huge eruption of tweets. To mention only one: Jikkyleaks (fan account) had this to say on Twitter about two trial sites. One, trial site number 4444 which recruited 1275 patients in the week from 22 to 27 March 2020. “And what is magical about the week of the 22nd September 2020? Well, that happens to be the last week that recruitment can take place for the data cut-off for FDA meeting in December,” he/she tweeted.
A further tweet stated, “The site doesn’t exist. It’s totally and utterly fabricated. There is no principal investigator for site 4444 because it doesn’t exist.” His guess was they needed the results from that non-existing site to give them to FDA for approval of the vaccine. So were the ‘perfect’ results from site 4444 manufactured? If not, Pfizer should come out with a clarification statement, but it has not thus far.
Yet another alleged scandal is that at another clinical trial – a phase III trial of the Pfizer-BioNTech’s Covid-19 vaccine site in Argentina, the head of the trial or the principal investigator was Dr Fernando Pedro Polack. The trial took place at a military hospital in Argentina and there are allegations of missing or largely compromised patient safety norms.
The rather odd (and perhaps fishy?) thing was Dr Polack had been closely associated with the FDA. The question then naturally arises – were the FDA and Pfizer collaborating or even conspiring together on the trials?
The first week of every month for the next eight to nine months promises more and more interesting, astonishing, and maybe even scary and scandalous information on how Pfizer was the first to come out with a ‘safe’ vaccine against Covid-19. Maybe, although we hope not, the anti-vaxxers may have the last laugh.