How did the pharmaceutical giant plan to push through approval of a failed vaccine?
In a level of chutzpa never before displayed by Big Pharma executives, Pfizer told the FDA essentially, “don’t worry that it hasn’t worked; approve it and then we’ll add another dose and we think that it will then start working.”
Legacy media jumped on board with America’s Frontline News’ assessment, but only after Pfizer itself dropped the idea(shortly after the Frontline News report). NBC News reported:
Pfizer’s request for authorization for two doses was an unusual request, given that the first two shots didn’t work and there is no guarantee that adding a third dose will be sufficient.
Pfizer reacted to the pushback against approving a drug without proven efficacy by treating it as a minor set back to their marketing plan. They moved forward, adding that third dose to their experiment on children under five and announced in May that the third shot did the trick, with an “efficacy of over 80%” and “only mild to moderate side effects.”
And how did Pfizer get their 80% number for preventing positive COVID cases?
There were a total of 375 COVID cases in the trial — 225 children who received the mRNA shot and 150 in the placebo group. (p.39). Adjusting for the larger sample size of those receiving the Pfizer shot, it turns out that 9.9% of the placebo group had COVID while 7.5% of the Pfizer group had it. That would be a 24% reduction in COVID cases.
This creates a problem for Pfizer, because the FDA’s guidance for the Licensure of Vaccines to Prevent COVID-19 states,
To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%.
How did Pfizer get its 24% efficacy above the FDA’s 50% threshold?
Pfizer removed 365 (97%) of the 375 COVID cases that occurred in its trial on children under 5 and analyzed only the remaining 10, claiming those to be significant cases since they occurred at least seven days after dose 3.
Of those 10 cases, 7 were in the placebo group and 3 were in the Pfizer group, leading to the 80% efficacy claim.