A credibility blow to Pfizer’s COVID-19 vaccine
By Maryanne Demasi, PhD
When the first doses of Pfizer’s COVID-19 mRNA vaccine arrived on Australian shores, Federal Health Minister Greg Hunt proudly announced that we could all be confident the vaccines had undergone “rigorous, independent testing” to ensure they were “ safe, effective, and manufactured to a high standard.”
As of 24 October 2021, approximately 21 million doses of Comirnaty (Pfizer) have been administered to Australians aged >16 years, with the understanding that drug regulators and public health officials have done their due diligence on the data.
Pfizer has promised that “every clinical trial is planned, conducted and reviewed according to the highest scientific, ethical and clinical standards.”
This week, however, a whistle-blower has lifted the lid on breaches in research integrity and safety involving one of Pfizer’s most pivotal mRNA vaccine trials.
An investigation by the BMJ has reported that a company called Ventavia, tasked with running a trial site for Pfizer’s COVID-19 vaccine study, “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events”.
The whistle-blower has revealed that she was fired after complaining about the company’s poor research practices, evidenced by dozens of internal company documents, photos, audio recordings, and emails.
The trial in question was Pfizer’s phase 3 study, involving around 44,000 participants in three groups aged 12-15yrs, 16-55yrs and >55yrs.
The complaints included the mislabelling of laboratory specimens, vaccines not being stored at proper temperatures and a lack of timely follow-up of patients with adverse events, all of which were verified by two former colleagues.
Where was the regulatory oversight? The FDA was notified of a complaint filed by the whistle-blower but failed to action any audit of the company.
One of the former employees characterised the data that had been generated for Pfizer’s mRNA trial as “a crazy mess”.
Paul Thacker, the investigative journalist who broke the story for the BMJ, is incredulous that these types of violations are allowed to occur.
“There were credible allegations of problems at this research site, the FDA did nothing and Pfizer hired the company [Ventavia] again,” said Thacker.
“Why is the FDA not inspecting clinical research sites when they are getting credible allegations about corruption? Where is the FDA office of criminal investigations? Where is the FBI healthcare fraud unit? They’re nowhere to be seen.”
“Instead, we just get told it’s science, science, science. If you say it enough times, it must be true,” he joked.
In what should have been international news, this latest whistle-blower case has barely registered in the mainstream media.
“We have a lot of science-cheerleading reporters,” Thacker said, “Pfizer has such a huge PR machine, they have basically captured the media, they’ve hypnotised the media”.
Pfizer announced that it expects to earn US$36 billion in revenue from its vaccine this year, the same week the Centres for Disease Control Prevention signed off on emergency use authorisation of the vaccine for 5- to 11-year-olds.
Trust the science?
At a roundtable meeting in the US Capitol this week, a group of highly respected experts (and vaccine-injured people) expressed grave concerns about the lack of data upon which policy decisions are being made.
“The evidence we have comes from highly curated, industry-controlled press releases and journal publications” said Dr Robert Kaplan from Stanford’s School of Medicine Clinical Excellence Research Centre.
“We are making big decisions based on limited, highly selected evidence. A compromised scientific process will lead to poor decisions, and it may set a bad precedent,” he added.
In Sept 2020, the CEOs of nine pharmaceutical companies released a joint pledge committed to “developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”
However, they stopped short of including any commitment or suggestion that the data underpinning their application would be shared with any other group of researchers.
Data kept secret
Repeated requests for access to COVID-19 vaccine data by independent researchers has proved futile.
“Data is the bedrock of science. If you cannot see the data, it’s not science, it’s business,” said Prof David Healy, from McMaster University, Canada.
For years, Dr Healy has treated patients who have experienced adverse drug events and is one of the few people to access internal drug company documents and trial data which have been subpoenaed in major legal disputes.
“Pfizer is not offering scientific information, it is offering you promotional material, they’re not in the business of looking after your safety, they’re in the business of selling treatments and making money,” said Prof Healy.
Dr Peter Doshi, a professor of pharmaceutical health services research at the University of Maryland, has been fighting the lack of data transparency for over a decade.
“If you are interested in analysing the data for Pfizer’s trial, you will have to wait until May 2025 before you can even request it from the company,” says Prof Doshi.
“What we’re following is not a process based on scientific data. We’re following a process where the data are treated as secret and, in my view, there is something very unscientific about that,” adds Prof Doshi.
In 2015, the Institute of Medicine published a consensus study calling for a culture change in which data sharing became the norm, not the exception, but not enough has changed.
“The point I am trying to make is very simple,” said Prof Doshi. “The data from Covid vaccines are not available and won’t be available for years. Yet, we are not just ‘asking’ but ‘mandating’ millions of people to take these vaccines.”
We are told to ‘follow the science’….but we do so, without data. A healthy dose of transparency is the only remedy.
If you enjoy my work, please consider supporting me as an independent journalist by signing up as a paid subscriber.