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Recommendation 2: The vaccine should be indicated only in those populations in which it has been trialled and found to have a positive benefit-to-risk ratio.
These are just a few selected posts presenting the evidence backing up the observations for recommendation 2. For a full list, subscribers can search our archives.
In June 2024, Kansas sued Pfizer for making “misleading and deceptive statements” and “violating previous consent judgments with the State of Kansas in which Pfizer promised never to use misleading statements in marketing their products”.
The Kansas Attorney General (AG) Kris Kobach stated at the time of the introduction of the vaccines, decisions to be vaccinated and which one to go for were made “in a hurry and sometimes under duress”. In such an environment, it is imperative that Kansas residents (and the whole world, for that matter) receive proper advice, the truth, not the spin. “In multiple respects, Pfizer did not provide the truth”.
Kobach’s evidence came from material obtained through FOIA via a lawsuit that highlighted several age groups that had not been included in the trials.
The list of issues included Pfizer's failure to disclose that it had excluded immunocompromised individuals from its COVID-19 vaccine trials.
After Pfizer obtained FDA approval through emergency use authorisation to provide its COVID-19 vaccine to 12-15-year-olds in August 2021, Pfizer decided to study “how often” its vaccine may cause myocarditis or pericarditis in children by testing 5-16-year-olds for troponin I.
Pfizer only tested the booster shot on 12 trial participants who were in the 65- to 85-year-old age range.
Pfizer did not test the booster on any participant older than 85 years old.
Read More: Kansas Attorney General report
Also what happened to the randomised controlled trial on pregnant women?
The trial that was planned in 4000 women had shrunk to 726, of which “348 maternal participants were randomised to receive treatment, and 335 were infants born to the maternal participants.”
So, 174 women started in each arm (30 micrograms of Comirnaty or saline placebo), and 161 and 159 completed the study with a second vaccination after 6 months of follow-up. The small numbers are a significant problem, but looking at the protocol, there is worse news. Women were enrolled only if they were 24 to 34 weeks pregnant in the Phase III trial or 27 to 34 weeks in Phase II. Note the three-week shift towards the term between the two Phases. This means the manufacturers did not test the vaccine's potential teratogenicity or toxicity on foetuses in the first 23 or 26 weeks of pregnancy.
Read more: Pfizer’s Covid Vaccine Trial in Pregnancy Finally Published Its Results
In 1984, the US Advisory Committee on Immunisation Practices (ACIP) first recommended that healthcare workers vaccinate annually against influenza. In 2003, ACIP began regularly updating the rationale for influenza vaccination programmes by targeting selected groups.
These are the categories they were targeting:
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However, how did the CDC ever decide which proof is sufficient for these different populations? In practice and clinical epidemiology, the answer is randomised controlled trials.
Across the ages, evidence exists for most of the effects central to the CDC’s campaign, but it doesn't speak to their objectives: In children under 2 years, inactivated vaccines had the same field efficacy as placebo; in healthy people under 65, vaccination did not affect hospital stay, time off work, or death from influenza and its complications.
In a BMJ article, Tom showed influenza vaccines heavily relied on non-randomised studies (chiefly cohort studies) to influence their use, especially in the elderly. Despite datasets of several million observations, safety was only reported in five randomised controlled trials (2,963 observations in total).
Studies are small and heterogeneous on the safety of inactivated vaccines, which is surprising given their longstanding and widespread use. In children, the situation is dire: A Cochrane Systematic Review found only one old trial with data from 35 participants aged 12-28 months.
Read More: And more Dots………Policy vs Evidence for Influenza Vaccines
These are just a few selected posts presenting the evidence backing up the observations for recommendation 2. For a full list, subscribers can search our archives.
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