pfizer's 12-15 year old data on trial: an investigation
First posted online: 3 March 2022
This is the untold and shocking story of Pfizer’s 12-to-15-year-old clinical trial. Just 2264 adolescents were randomised between October 2020 and January 2021. I will describe the various related, serious and life-threatening injuries sustained by these youngsters.
1180 of these youngsters received at least one 30μg dose before the data cutoff date, 13 March 2021, comprised of 1131 adolescents during the blinded study and 49 from the placebo group, who turned 16, were unblinded and chose to be treated under the FDA’s recent 16+ EUA.
Although the study’s sample size was tiny and its statistical power weak, clinical trial data (however incomplete!) is as gold dust, as it represents a closed cohort. It can detect a crucial safety signal before treating every adolescent on the planet.
1 related life-threatening fever
1 related life-threatening anaphylaxis
1 related with “reasonable possibility” myopericarditis, hospitalised, "limited activity" advised at 2 months
3 on SSRI medication for depression, each hospitalised with symptom "exacerbation"
One more. Maddie de Garay suffered severe abdominal/chest pain and extreme numbness within a day of dose 2. She developed blood in her urine, mobility issues, is now paralysed and uses a nasogastric tube to eat. Mislabelled as "functional abdominal pain" and "neuralgia".
Aside from those 7 youngsters, lymphadenopathy, swollen lymph nodes, occurred at a statistically significantly higher rate in the treatment group (9 vs. 2). Likewise for lymphadenopathy instances judged to be related to treatment (7 vs. 1).
The reactogenicity safety data is dramatic. These side effects were likely too obvious for the study blind to be maintained. The study’s administrators were unblinded anyway! Post dose 2, in the treatment group, 51% used antipyretic medication vs. 9% in the placebo group.
There were no severe COVID-19 cases in either group. What was the efficacy "benefit" for all these injuries? The clinical endpoint was symptomatic infection confirmed by an NAAT test. We don’t know the positive PCR Cts, the symptoms, nor whether transmission was reduced.
To reiterate, the study’s data cutoff date was 13 March 2021. These injuries were all known by the time:
Pfizer boasted their drug was "well-tolerated"
the trial results were published in the NEJM
the MHRA extended the Reg. 174 TUA
the JCVI advised the UK-wide rollout
Serious adverse events were observed during the study's open-label period
Reactogenicity data was dramatic in the treatment group