[Editorial Update: 25 Nov, 10:10am] We have updated the article to reflect a clarification SPF has provided us on the situation.
We were alerted to this photo being shared on Telegram:
The text in the photo alleges that the Singapore Police Force (SPF) has initiated an investigation on Pfizer for “Phase 3 COVID-19 vaccine data fraud”. Another line of text at the bottom half of the image purportedly quotes a Dr IW Yang, who said that The BMJ had agreed to “share the evidence of fraud with the Singapore Police Force”.
For context, The BMJ is a weekly peer-reviewed medical trade journal, published by the trade union the British Medical Association (BMA). It is also one of the world’s oldest general medical journals, with its first edition having been published in 1840.
Dr IW Yang is a Singapore doctor whose name has appeared on 2 open letters to the Ministry of Health (MOH). The letter penned in May called for MOH to approve a killed-virus vaccine and highlighted concerns about mRNA vaccines and its potential long term side effects, especially on children. Another letter penned in June called for “a pause in Singapore’s vaccination exercise until the US Centres for Disease Control and Prevention (CDC) and organisations elsewhere have produced more robust and convincing data on the case”.
It is uncertain where the creator of the photo got his/her information from, given that there has been no publicly available reports about SPF conducting such an investigation.
It is also puzzling how and why SPF would be involved in such an investigation in the first place.
What does “phase 3 COVID-19 vaccine data fraud” refer to?
Given the sheer amount of name dropping in a single image, let’s first look at what “phase 3 COVID-19 vaccine data fraud” could be referring to.
When we did a Google search of the terms ‘covid 19 phase 3 pfizer bmj’, we were led to an article on The BMJ which was published on 2 November 2021.
Titled “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial”, the article reports on allegations made by Brook Jackson, a former regional director at research organisation Ventavia Research Group, one of several companies which ran Pfizer’s Phase III clinical trials.
For context, the full trial enrolled around 44,000 participants across 153 sites that included numerous commercial companies and academic centres. Jackson wrote in an email to the US Food and Drug Administration (FDA) dated 25 September that Ventavia had enrolled more than 1,000 participants at three sites.
In the exposé, Jackson told The BMJ that Ventavia had “falsified data, unblinded patients (i.e. researchers could see who was receiving the vaccine and who was receiving a placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial”.
After notifying Ventavia of the problems repeatedly, she emailed a complaint to the FDA, but was fired later the same day.
Jackson was also reported to have provided The BMJ internal company documents, photos, audio recordings, and emails as evidence.
The BMJ also spoke to two former Ventavia employees, both of whom “confirmed broad aspects of Jackson’s complaint”.
Pfizer’s Phase III clinical trials and its implications on vaccination drive worldwide
As a quick background, the result of Pfizer’s Phase III clinical trials was announced in November last year.
In the announcement, they reported that analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior COVID-19 infection. The announcement also reported that Pfizer and BioNTech planned to “submit a request to the FDA for an EUA (Emergency Use Authorisation) based on the totality of safety and efficacy data collected to date”, and that “these data also will be submitted to other regulatory agencies around the world”.
For some local context, on 14 December, the Health Sciences Authority (HSA) of Singapore granted authorisation for the Pfizer-BioNTech COVID-19 vaccine to be used in Singapore. This was based off HSA’s review of “available clinical data”, and how “the vaccine demonstrated a high vaccine efficacy of 95%”.
Ventavia Research Group: “No part of (Jackson’s) job responsibilities concerned the clinical trials at issue”
Following the exposé on The BMJ, Ventavia came forward with a statement, saying that the author “did not contact Ventavia prior to publication”, and that “the accuser (Jackson) was employed for approximately two weeks in September 2020” and “no part of her job responsibilities concerned the clinical trials at issue”.
However, in a writeup on the issue by The Conversation, we read that Jackson showed the publication an internal Ventavia email dated September 2020 in which Jackson was introduced as a “new employee and Regional Director”, and which states that “she will be overseeing” two sites “for the COVID1001 study”.
Should there be a cause for concern?
While the jury is still out regarding the accusations that have been made by Jackson about Ventavia Research Group, perhaps the more worrying thing is whether or not this means that we should feel less confident about COVID-19 vaccines.
In fact, CBS17.com pointed out that the report “was making rounds on social media, with vaccine skeptics pointing to it as justification for their skepticism”. Even the author of the article on The BMJ acknowledged that “people are going to use this to push a political position because that’s what they’re interested in”.
However, Dr. Jill Fisher, a professor of social medicine at the University of North Carolina and an expert on clinical trials, told CBS17.com that this shouldn’t mean that individuals should feel less confident about the vaccine.
It is also important to note that Jackson had shared that Ventavia accounted for “at least 1,200 of [a total of 44,000 trial participants] and accounted for three sites [across 153 sites in total]”. Said Fisher on this detail: “If all of the clinical trial data were dependent on one particular site, and that site’s data were called into question, I think it would be a much bigger concern.”
SPF: “The Police will not be taking further action on the report”
When we reached out to SPF for clarification, a spokesperson replied: “The Police confirm that a report was received. After careful consideration of the available facts and circumstances of the case and in consultation with the Attorney-General’s Chambers, the Police will not be taking further action on the report.”
The spokesperson added that the information in the report has since been conveyed to the Ministry of Health and Health Sciences Authority.
Therefore, while it is true a report was indeed filed to the Singapore Police, it is false that there is an ongoing investigation by the Police into the case.