Pfizer Vaccine shows no evidence of reducing COVID-19

Say what?

Yes, it’s true. The study that showed a “95% efficacy in reducing COVID-19” didn’t actually measure how many subjects contracted COVID-19.

Yes, I’m rather amazed myself. Not that it got by the rubber stamp FDA, but that Pfizer had the balls to design a study that wouldn’t study what was supposed to be studied.

Instead of measuring COVID infections, they made up a definition of a COVID-19 case and went ahead and based the study on completely irrelevant data.

FYI, here’s are the two definitions of a COVID-19 case.

1. From the Pfizer study

For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the
presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4
days of the symptomatic period:
• Fever;
• New or increased cough;
• New or increased shortness of breath;
• Chills;
• New or increased muscle pain;
• New loss of taste or smell;
• Sore throat;
• Diarrhea;
• Vomiting.

Source: FDA briefing document page 14

2. From the CDC web site:

• Meets confirmatory laboratory evidence

Source: CDC COVID-19 Case Definition

So what the study actually found was that the vaccine was 95% effective in reducing specific short term symptoms of people who contracted COVID-19.

Interestingly, it doesn’t include fatigue, nor lost voice, which were the main two symptoms I had (along with difficulty breathing).

But anyway, it was a successful and, as far as it went, and honest study right?

Maybe not.

For the sake of evaluating the efficacy, the study precluded anyone who has “important protocol deviations” whatever that means. Usually, protocol deviations are determined to be significant or serious. Important is rather subjective (e.g. it’s important that I eat today, though my calorie intake may not seem particularly important to you).

Evaluable efficacy: All eligible randomized participants who receive all vaccination(s) as
randomized within the predefined window and have no other important
protocol deviations as determined by the clinician.

Source: FDA briefing document page 16

Somehow, there were 311 “Important protocol deviations” in the vaccine group and just 60 in the placebo group.

That may not sound like a lot out of around 16,000 in each group. But when you consider that there were only 9 “cases” in the vaccine group and 162 in the placebo group, it may make you wonder how these clinicians determined the protocols to be “important.”

Also, nobody died of COVID in this study, so there’s zero evidence that it could save a single life.

Anyway, go ahead and get the vaccine. It probably won’t stop you from dying, getting COVID, or transmitting COVID, but at least you’ll be 95% less likely to display mild symptoms.

Cheers,

P.