Pfizer's numerical gymnastics part 1

Looking at 'efficacy' in children 6-23 months

It’s been a hectic week — so much to say about so much, and I did say a lot of it in my FB group which is, of course, no longer viewable.

I’ve been going through the VRBPAC and ACIP presentations and documents from the last week, slowly picking out the incongruities and outright lies, but as I’ve been doing so, I find myself going down ever deeper and more convoluted rabbit holes, so it’s going to take me a bit more time to really crunch through what is actually written and what was spoken. But I will work at simplifying and explaining everything that I find, as it is so critical now for parents who are on the fence, or scheduled for routine pediatrician’s visits to truly understand what these authorizations are based on so they can stand firm and say ‘No’ to these nightmare products.

A relatively simple one today: Pfizer’s efficacy in those 6 months to <2 years.

Pfizer’s efficacy for for the second dose is notoriously bad. They were forced to extend their trial with a third dose because it couldn’t even pass the low bar that the FDA set for them. How bad? See the table below from the FDA’s briefing document which breaks down efficacy based on the predominant variant.

Note the efficacy of approximately 0 for infants between 6 and 23 months for omicron. It just doesn’t work. But they did find it ‘efficacious’ for Delta, and so combined that efficacy for a slight boost to the total.

Why does this distinction matter? Because Delta (and all other previous variants besides omicron) are extinct. They are no longer in circulation. According to the CDC’s Variant surveillance, they haven’t existed for a long time.

But that data was just from after the second dose. Their claim was that three doses were needed, and that that booster against the original wild type would somehow improve things with omicron.

Well, take look at the table below from the FDA’s review of Pfizer’s data.

Ouch.

They’re only counting 3 total cases to come to a point efficacy of 75.5% And they aren’t even counting one case that occurred within 7 days of the third dose. They conveniently used the impossibility of dividing by 0 cases in the placebo group to skip over the true negative efficacy in that time frame.

In fact, they’re ignoring 153 other cases that occurred during their study.

The ACIP members actually did press the Pfizer representative on the non-existent efficacy for 2 doses. But they accepted his argument that the ‘trend’ was looking good.

Nobody talked about this little gem on page 57 in the FDA’s review document though:

Some unknown number of children experienced a second infection during the study period, most with other coinfections.

All but one of that unknown number had had 3 doses of the Pfizer shot.

Now how exactly is that pointing to better efficacy for a third dose?