Starting in August 2020, i-Trials, a company owned by Fernando Polack, his family, and colleagues, set up to run clinical trials on a commercial basis, recruited 5,768 of the 43,548 volunteers randomized to either BNT162b2 or placebo in what is usually called Pfizer’s trial, although the trial was actually set up, run by and supervised by ICON.
The Buenos Aires 5,768 made over 13% of the total recruited. It was 15% of what ICON/Pfizer called the main safety population (37,706).
There were 152, 153 (or 154) sites in this trial. of which 1 was in Argentina, 2 in Brazil, 6 in Germany, 9 in Turkey, 4 in South Africa, with 131 in the USA.
On most days the Polack group, operating from the Hospital Militar in Buenos Aires recruited 260-280 subjects. This was comfortably more on a single day than 79, more than half, of the other sites individually recruited during the entire course of the trial. It was roughly the same amount per day as 22 other sites recruited in total. Buenos Aires recruited in 2 days what most of the 50 remaining sites included in total.
The only other country, whose two sites combined came close to half of this rate of recruiting was Brazil which recruited 2,284 volunteers (6.1% of the total). Combined Argentina and Brazil recruited over 21% of the total safety population.
Famous for Fish
Earlier posts (Fishy Business) drew attention to a strange feature of the Buenos Aires operation. There were apparently two sites. The centre at which recruitment began was designated 1231 but then a further 1250+ patients were recruited from a centre in the same Hospital Militar with the same research personnel, but labelled 4444 rather than 1231. Why?
Lots of people have speculated about this and come up with all sorts of explanations. And it is difficult not to at least intimate there might have been something dodgy about all this.
The reason may be simple.
Recruiting started in centre 1231 slowly on August 6. It was initially 10 per day for a few days before picking up to 260+ daily in mid August.
Recruiting to centre 1231 stopped on August 31. It had wound down to 150 per day by August 31 but at that point the first subjects scheduled to have the second Dose of the Vaccine had begun to arrive and these built-up in number. These began appearing on August 27, 3 weeks after Dose 1.
So centre 1231 continued to handle 260+ per day.
A new operation (4444) opened up three weeks later on September 21, just as the final Dose 2 shots for the intiail cohort were being given. Site 4444 recruited an additional 1250+ volunteers in 5 days.
September 21 gave Polack and iTrials exactly enough time to the day to recruit over half of the Brazil total, wait three weeks, and then give them their second dose and fit in 5 weeks (one week that didn’t count after Dose 2 and then 4 weeks that did count) before testing for infection right up to the closing date for data collection in the trial which was November 14.
New York Journal of Medicine
Important medical news once featured in medical journals – like the New England Journal of Misinformation who have shown themselves fully capable of accommodating corporate interests – waving any need to meet scientific norms by asking to see the data or follow up on queries from someone like Bri Dressen as to why she was written out of history.
Instead, we have ‘science’ by company press releases, with companies based in New York (and elsewhere) filling the pages of the NYJM – these ‘scientific’ publications count for more with the wider media and politicians and investors than anything that might appear in NEJM and related legacy media.
On November 9, a week before the trial closed, Pfizer had what retrospectively looks like a strange press release – ‘scientific’ position paper.
Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study
- Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
- Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
- Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
- Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
What’s strange about this?
If Pfizer only had 94 cases of COVID after three months recruiting and planned to continue until 164 cases had been recruited, this sounds like 2 more months of recruitment were needed. But the study finished a week later.
Second, the press release makes clear that before the trial ends, Pfizer are already dealing with a final number of 43,538 volunteers.
Third, Albert Bourla (Pfizer CEO) mentions in his almost certainly ghostwritten book, Moon Shot (too rude for an image), that just a few weeks later he and colleagues were hanging breathlessly on the end of the video call waiting to get the results of the trial and giving the impression that he has no idea what these will be, hoping they will clear 50% efficacy. He is stunned (gobsmacked) to find they have 95% efficacy.
Finally, Pfizer later decide they need more than 164 confirmed cases – they need 170 cases. To get to this, they seem happy to break the original trial rules as set out in the protocol.
In an Emergency…
On December 11, FDA issued an Emergency Use Authorization (EUA) for Pfizer’s submission package, on the same number of recruited volunteers, which now had 170 cases, stating among other things that they now had a mean of 2 months follow up data for those recruited which appears to mean that data was perhaps still being sent into FDA up to about December 9, almost certainly after the blind was broken.
How much time was there for FDA to review anything? FDA said independent medical officers and agency staff had reviewed the material thoroughly.
The approval meeting at which independent experts were present – the Vaccine and Related Biological Products Advisory Committee (VRBPAC) – was on December 10. Pfizer prepared the Key Document for this EUA from which everyone took their cue. So scrutiny by independent experts was minimal and controlled.
A ghostwritten article, with Fernando Polack as its first notional author, appeared online in the New England J of Medicine on December 10 and in print on December 31. Most readers likely figured this article had been through a detailed review process by reviewers who had access to the data as per scientific norms. Few likely spotted the main author of the paper was based in New Zealand and the company that ran the trial was based in Dublin – although it was all there in the small print at the end.
What the Polack article doesn’t say is that:
All the 170 cases that were central to the approval came from 66 of the 153/154 sites. So, 87 sites or thereabouts contributed no cases.
Of the 66 sites that contributed cases, Buenos Aires contributed 36 cases – all bar one were placebo cases. This is double the proportion of placebo to vaccinated cases found in the other sites combined.
What it does say is that the cut-off for the EUA safety data was October 9 – making it very uncertain why site 4444 came into being because all of the volunteers at this site had Dose 2 in mid-October.
Do Whatever Steps you Want
On the Banks of the Ohio, there were 9 sites in 5 cities that recruited 2,135 patients who provided 6 cases between them. If these 9 sites had each contributed roughly what Buenos Aires contributed, the entire trial could have been run from Ohio.
By the Waters of Buenos Aires, we sat down and…. – watched the dancers.
First you get down on your knees,
Fiddle with your rosaries,
Bow your head with great respect,
and genuflect, genuflect, genuflect
Do whatever steps you want to, if
You’ve cleared them with the Pontiff…
Doin’ the Vatican Rag
To be danced or sung to the Tom Lehrer Rag.
Continued over the next two weeks.