On Saturday, Useless CDC Director Rochelle Walensky announced a new recommendation to vaccinate all 20 million children 6 months to 5 years of age. Here are some things left out of the announcement that parents should know.
1. The research was inconclusive
The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe COVID-19 infection. As a result, the FDA allowed both companies to extrapolate effectiveness by measuring antibody levels, pointing to data from older children and adults.
There were no cases of severe COVID illness in either the vaccine or placebo group. The Moderna vaccine had 4,774 children and the Pfizer vaccine had 4,526 (including those who received the placebo).
Pfizer concluded that their vaccine was 80% effective in preventing symptomatic COVID-19, but based it on 3 cases in the vaccine group and 7 cases in the placebo group in a subset of children who received a third dose.
Even this was not statistically significant. In fact, it had a confidence statistic so wide, you could drive an aircraft carrier through it. (They reported the largest confidence interval I have ever seen in my 20-year research career). At one end of the range of possibilities indicated by the confidence interval, the vaccine could be associated with a 370% increased risk of getting COVID-19. The Moderna trial reported a short-term efficacy of 38% in preventing symptomatic illness–an effect well-known to be transient.
Ironically, there were more overall hospitalizations (unspecified) in the vaccine group. Out of a total of 7 children requiring hospitalization, 6 were in the vaccine group and 1 was in the placebo group, which was half as large.
The Useless CDC even said in its own slides at their deliberation meeting that data assessing efficacy were poor, characterizing them as “very low certainty” and noting that there are “very serious concerns for imprecision due to study size”. They also noted the very short follow-up time of 1.3 months.
2. The FDA lowered their standards for acceptable vaccine efficacy needed to approve
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Author: Ruth King
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