Urgent Message to Parents Considering the C-19 Vaccine for Children

The Pfizer vaccine for children has recently (June 2022) been approved under emergency use authorisation (EUA) in the US for under 5 yr olds.  The NZ government has followed the US lead with decisions to approve vaccination in various age groups thus far, so it is likely the Pfizer vaccine will be approved for under 5s in due course.  Start your research now so you will be prepared with your questions when the approval occurs and the advertising begins in earnest.

This document is the study data that was presented by Pfizer to the FDA in May 2022 that enabled EUA to be granted for its vaccine for children, including babies and toddlers.  It is not easy to read but some salient points from it include: 

• There were no Māori or Pacific babies in the trials and no Māori and only 3 native Hawaiian or other Pacific Island 2-4 year olds were included.
• Only 4,526 children were enrolled.  This means side effects that may occur in 1 per 10,000 children might not be detected.
• There were only 2.1 months median follow up which means that there is extremely limited short-term data and no medium- or long-term data. 
• The trial protocol changed part way through the trial – a third dose was added as two doses did not show a satisfactory antibody response.  It is not normal scientific procedure to change protocols part way through trials.
• Presumably due to this protocol change, the length of time between second and third doses varied immensely from 42 to 245 days.
• Participants were unblinded part way through the trial and the placebo group were offered vaccination so now it will be impossible to determine medium- or long-term adverse effects.
• Only 992/3013 (< 1/3) participants that were in the vaccine arm completed three doses and had data available for analysis.  In the baby vaccine group only 386/1178 received 3 doses, in the toddler vaccine group only 606/1835 received all three doses.  What happened to the others two thirds and how is statistical significance affected? These are important questions that have not been answered and should be answered before conclusions can be drawn from a research trial.  Usually if 2/3 of participants were not included in the analysis, the trial would be considered invalid.
• Real world vaccine effectiveness for prevention of illness was not adequately studied.  Instead it was inferred by immunobridging which is measuring antibody levels before and after vaccination and comparing the change with that which occurred in 16-25 year olds.
• Antibody levels against the Wuhan strain were much higher than antibody levels against Omicron but the clinical relevance of these and other antibody levels is unknown at this time.
• Only preliminary efficacy data has been provided as the protocol specified 21 covid cases had to be included to allow for analysis and there were only 10 cases meeting criteria for analysis by the cut-off date.  How can we draw conclusions on preliminary data only?
• For vaccine efficacy, only cases of Covid occurring at least a week after dose three (10 cases – 3 in vaxxed, 7 in placebo) were counted.   365 covid cases occurring prior to 7 days after dose 3 were ignored, presumably because they occurred prior to supposed development of protection from the vaccine.  This included 153 covid cases in babies and 212 in toddlers; 222 cases in vaxxed groups and 143 in placebo groups.  What does dismissing 97% of covid cases do to the credibility of the study?

Other Questions About the Vaccine for Children

Is it valid to compare the immune response of babies, some of whom will still be breastfed, with young adults?

Where is the evidence that the outcome used in the trial (a certain level of antibody) will be protective against contracting or transmitting Covid or preventing severe disease, when this is a disease that barely affects babies and toddlers?

Which buffer (Tris or PBS) was used in these vaccine for children trials and which buffer will be in the vaccine administered to babies?

Should we trust Pfizer given their criminal history?

Can the current Pfizer clinical trials be trusted at all given the evidence of fraud in the initial trial?