In the 11 subseries of three posts, we defined effectiveness outcomes that we thought were important.
how they are defined and reported in the package inserts
and how they are reported in the regulatory documentation
We noted that the definitions were unsatisfactory, death from or with Covid had no definition, and the incidence of disease in the placebo arm was very low (even with a leg up from misreporting of PCR), undermining the whole emergency narrative (as noted by switched on reader).
In 12a, we went back on the harms in package inserts which were inconsistently reported and with difficult-to-compare incidence estimates.
Finally, we thought we’d lift the gloom by inserting a little bit of old geezer humour in
Here is a summary slide to help you navigate through it all:
We will continue to monitor what is going on. However, the bottom line is that due diligence has not been carried out. The consequences will become clearer as time passes.
Remember that two old geezers wrote the series, not impersonators. It is not commercial in confidence. It is not carcinogenic and will not self-disrupt or autodelete. We are not on the payroll of any pharmaceutical company, and given the content of our posts, we have been notified that HMG will award us the Order of the Concrete Boot, Socks, Vest and Hat. We apologise to MEDSAFE and can now confirm that their book of straight answers is the second smallest book in the library. The first place is now occupied by the book of evidence of interruption of SARS-CoV-2 transmission by Comirnaty.
Someone has put a quote from Fauci’s new book on social media where they describe Fauci getting a phone call on a Sunday evening from Pfizer CEO Bourla:
‘“What’s going on, Albert?” I asked, trying to sound upbeat as my stomach lurched. “You won’t believe it, Tony!” he exclaimed. “The DSMB looked at the phase 3 trial data from the COVID vaccine trial, and there is more than 90 percent efficacy.” He was talking about the Data and Safety Monitoring Board, which independently monitors clinical trials to determine if any issues have arisen during the trial that affect the health or safety of patients. At the same time, if results are so good that it would be unethical to continue to give placebo instead of the vaccine, the DSMB can recommend that the trial be terminated early and the data submitted to the Food and Drug Administration (FDA).
This was the case here. Albert continues, “We are planning to announce the news tomorrow.”
After we hung up, tears welled in my eyes and I felt as if I had lost my breath.’
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The interim trial results were reported in Science on 9 Nov 2020: ‘The subsequent efficacy trial, which has enrolled more than 44,000 people, quickly yielded results because of the skyrocketing number of COVID-19 cases in the United States, home to the vast majority of the trial's 154 sites. The study design called for a data monitoring committee (DMC) to unblind the data if 62 participants had symptoms of COVID-19 and tested positive for SARS-CoV-2…So far, the trial has found no major safety problems. For safety reasons, FDA guidelines say before a company can seek an EUA, 2 months must pass after at least half of the participants in a vaccine trial have received all of their doses. That point is about 2 weeks from now, and Pfizer anticipates the trial will, by then, have reached its planned endpoint of at least 164 COVID-19 accumulated cases. If the vaccine is formally deemed safe and effective or given an EUA by FDA and regulators in other countries, an ethical dilemma comes to the fore: whether to offer it to the participants in the study who received the placebo, which could compromise the trial's ability to collect more data on the durability of its immune response and safety. Other COVID-19 vaccine trials might also be compromised: Participants might drop out if they can access a 90% effective vaccine.’
So aside from the fact that some people’s definition of ‘skyrocketing’ is a bit suspect, it looks as though as early as Nov 2020 there was a plan to terminate the phase 3 trial early, because apparently it would have been ‘unethical’ not to offer vaccination to placebo subjects. But of the 34922 participants included in the Dec 2020 Polack trial write-up, 15372 were aged 16-64 with no risk factors for severe covid and a further 3412 were >65 with no risk factors.
Given that the early termination of the trial has impeded subsequent analysis of product safety (and our ability to give proper informed consent), I’m not sure that the ethical case for unblinding and vaccinating the 7671 low risk placebo participants under 64y was a robust one, even knowing what we knew at the time.
And this week in the New Scientist we finally get to hear of the results of a 2021 UK Covid-19 challenge study: Of 16 immune naive low risk people who had original variant SARS Cov2 sprayed up their noses, 7 (44%) consistently tested negative and 3 tested pos with no symptoms; only 6 people (37.5%) developed symptomatic infection! The rest were protected by their innate immune systems (HLA DQA2) with interferon production.
ragazzi come sempre siete fantastici !!! oltre a tutti quei premi meritate anche una fetta ... no, meritate una torta con i bignè e il cioccolato sopra. fantastici! ♥