ACIP Approves Pfizer Vaccine for Adolescents 12-15 Despite Limited Safety Data
Just days after the FDA granted EUA to Pfizer’s COVID vaccine for 12-15 year olds, ACIP has given the “recommendation” for adolescents in this age group to get the experimental vaccine.
Click here for the slides from the presentation.
Click here for the Pfizer vaccine FDA factsheet.
Pfizer’s phase 2/3 trial included a total of 2260 adolescents:
- 1,127 who got the vaccine
- 1,127 who got the placebo
Of these, 660 of the vaccine group were followed for up to 2 months past their second dose.
This recommendation will lead to the vaccination of millions, but there is no way to predict the number of adverse reactions based on following 660 children for 2 months.
Also worth noting, 30 of the children did not get their second dose, vs. only 1 in the placebo group.
However, still, even in such a small group, unsolicited serious adverse reactions were more likely in the vaccine group verses the placebo group. (0.4% vs 0.1%)
From the factsheet:
Unsolicited Adverse Events: In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at least 30 days of follow-up after Dose 2.
Serious Adverse Events: Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.
Non-Serious Adverse Events: Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.
I’m not surprised because these ACIP members all have tunnel vision and sounded afraid to have questions and concerns.
The amount of time spent on co-administration even though they acknowledged there is literally no data to support this recommendation exemplifies the blind faith these people have.
One member said even though there is no data, he has “expertise”–and that is supposed to be a substitute for actual data??
That’s how we got ourselves into this heap of a mess in the first place, everyone thinks their experience in the field, their credentials, their “expertise” mean more or is an adequate substitute for raw observational data. All the while ignoring the evidence right in front of their faces.
Their primary focus is on the target infection, and preventing it at all costs, but never at the unintended consequences.
Real world experiences, adverse reactions never make it through the door because it doesn’t match the pre conceived prejudices and bias.
Since when is science so one-sided?
If a vaccine postpones, prevents, or attenuates a targeted infection, but exacerbates a current condition, triggers an underlying condition, causes a severe adverse reaction—can we still call it safe and effective?
I listened to Tom Shimabukuro say that VAERS is primary system for monitoring adverse reactions, for picking up signals, and yet these are the same people who believe that all these serious adverse reactions are not related to the vaccine, or coincidental.
FIVE
There were 5 serious adverse reactions reported in the 12-15 year old group vs. 2 in the placebo group, by the 2 month cut off. One of them is Maddie. They characterized her as having “Abdominal pain, constipation and neuralgia were in the same participant”—well they left off paralyzed from the waist down, unable to keep food down, lost 15 pounds, tremors in her arms, 20 blackouts a day, chronic urinary retention, severe pain, no leg movement.
Pfizer deemed her experience ‘not related to vaccination’.
There you have it. 1 out of 1,100 to be paralyzed and permanently injured is a coincidence.