27 Aug 2022 3:01 pm
4) When comparing cases one week after the 3rd dose, only 10 cases occurred, with 7 in the placebo group and 3 in the vaccinated group. Thus, a total of ten cases out of 4,526 children enrolled was the entire extent of the used to support authorization.
- In light of this paucity of data, their own comment on efficacy was worded as follows: “Vaccine efficacy post Dose 3 cannot be precisely estimated due to the limited number of cases accrued during blinded follow-up, as reflected in the wide confidence intervals associated with the estimates.”
- More disturbing is that safety was only monitored for 6 weeks before they decided to vaccinate the children in the placebo group, an unprecedented lack of follow-up for both short term and long-term safety.
- The trials for children 2 through 4 years old failed to meet FDA-specified requirements for COVID vaccine EUAs. The vaccines did not show 50% efficacy nor meet the required 30% lower bound with a 95% confidence interval. Given these data, there is no support for the proposal to use a product and schedule that failed FDA‘s established criteria in its clinical trials.