Why the FDA Should Not Have Approved the Pfizer Covid Vaccine for Infants

Severe Covid higher in the vaccine arm than in the placebo, two-thirds of the children dropped out, 97% of the Covid infections were ignored – Dr. Clare Craig, a diagnostic pathologist and Co-Chair of the HART group, explains in a short video why the Pfizer trial for Covid vaccination of infants aged six months to four years-old should be deemed null and void. The FDA voted unanimously on Wednesday to approve the drug for this age group. There follows a transcript of the video.

🧵 1/ Dr Clare Craig explains why the FDA should NOT have granted approval for roll-out in the 6 month to 4 yr old children cohort

This trial should have been deemed null and void. The regulators are failing to do their job.

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— HART (@hartgroup_org) June 16, 2022

I’m Dr. Clare Craig, I’m a diagnostic pathologist and I’m Co-Chair of the HART group. And I want to take you through the evidence that Pfizer just presented to the FDA on the six month to four year-old children.

There’s an awful lot about this trial that has shocked me and I think will shock you too.

The trial recruited 4,526 children aged from six months to four years-old. 3,000 of these children did not make it to the end of the trial. That is a huge number. Two thirds of them. Why was there this drop off? That needs to be answered. And without an answer to that, on that basis alone this trial should be deemed null and void.

So, what did the trial show? Well, they defined severe Covid as children who had a slightly raised heart rate or a few more breaths per minute.

There were six children aged two to four who had severe Covid in the vaccine group but only one in the placebo group. So, on that basis the likelihood that this vaccine is actually causing severe Covid is higher than the likelihood that it isn’t.

There was actually one child who was hospitalised in this trial. He had a fever and a seizure. He had been vaccinated.

So now let’s turn to what they defined as any Covid. And what they did was to utterly twist the data.

They vaccinated the children and they waited three weeks after the first dose before the second dose. In that three-week period, 34 of the vaccinated children got Covid and only 13 in the placebo group, which worked out as a 30% increased chance of catching Covid in that three-week period if you were vaccinated. So they ignored that data.

And then there was an eight-week gap between the second dose and the third dose, where again plenty of children were getting Covid in the vaccine arm. So they ignored that data.

There were then seven days after the third dose, which they also ignored.

Which meant that in the end they had ignored 97% of the Covid that occurred during the trial and they just looked at tiny numbers – so tiny. In the end they were comparing three children in the vaccine arm who had Covid with seven in the placebo arm, and they said that this showed the vaccine was effective.

Stop Press: Read HART’s full analysis of the trial here.