Pfizer Study

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine has come out in the New England Journal of Medicine. I was wrong again. I thought the 95% was a consequence of confusion between oncology and epidemiology. The study was conducted by Pfizer. I had thought it was fortuitous that an mRNA vaccine that avoids the issue of white blood cell response was easier to develop.

The study:

 “RESULTS

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.”

Dropping the statistical blessing they divided 8 by 162 and got 0.0493827160493827 or 5%. 100% - 5% gives 95%. Another way to say this is: 8 of 21,720 vaccinated participants, or .037% reported sick.  162 of 21,728 placebo participants or .75% reported sick.

The study was monitored by survey:

“With the use of an interactive Web-based system,”

According to the protocol, blood samples were taken. I see no record that positive results were excluded. I see no reporting of the blood immune results at all. Swab tests are unreliable.

“Overall, BNT162b2 recipients reported more local reactions than placebo recipients.” 

Participating in the study is itself a selection factor. The participants knew by their reactions whether they had received the placebo or the vaccine. Those who thought they had received the vaccine were more likely to dismiss symptoms. Those who thought they received the placebo were more likely to report them.

Everyone vaccinated should then show a positive blood test, presence of antibodies. It is more certain that a placebo candidate is sick. Vaccinated candidates who report sick have to report and get accurately swabbed within four days.

 This is a busted study.

At this point you may wail:

-OK, forget the study! Look at the science!

The research money was sucked up by the drug companies. There is no science. All we have is your recipe.

Speculation: (This is where I will be wrong again.)

1.    I speculate that our infection by Sars-Cov-2 of our symbiotic or pathogenic cells creates the virus that provokes our immune response. I am trying to explain how a glycan coated virus triggers immunity. Do mRNA vaccines communicate to our foreign cells?

2.    Are the adverse reactions a consequence of prior infection? I bet that the 8 infected vaccinated participants did not have adverse reactions. I am sure that they had prior negative blood tests. This study may have been an expensive survey of prior infection.

3.    Does the vaccine treat existing illness? Obviously not, or it would have been reported. Why not? Does it make the illness worse? I predict this question will be the source of most resistance to vaccination. Please don’t compare to existing vaccines. Creating mRNA should be palliative.

Recommendations:

1.    Proficiency in Statistics must be a requirement for the medical profession.

2.    Reported blood immune tests before and after such studies. I expect that all vaccinated participants will have a positive test. This would be a good audit.

3.    Disaster that all the research money was given to drug companies. First look at the problem, then examine the problem, when you are done – study the problem.

I am a courteous person. I won’t refuse a vaccine. I have little hope for them.