According to the data of the protocol presented by Pfizer about the successful phase 2/3 study of the SARS-COV -2 RNA vaccine against COVID-19 (« A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS»), the efficacy of the vaccine is around 95%. As it follows from the protocol, 164 participants from the placebo group caught COVID-19 versus 8 participants from the vaccine group.
It is reported that the study took place in the USA, Germany, Turkey, RSA, Brazil, Argentina.
In this connection, we draw attention to the fact that the contamination level in these countries is significantly different.
It is worthwhile noting that as of 12/25/2020, the proportion of the total infected population in those countries is as follows:
The standard deviation is 1.5%, which is too much.
This means that the rate of the infected in the USA is 3.5 times as much as that in the RSA.
Based on the protocol, we have no idea about the origin of the participants in phase 2/3, i.e. 90% of the trial subjects could come either from the USA or 90% could come from the RSA.
This information is highly critical as it should reflect the rate of real cases in the placebo group.
In other words, if 90% of the participants are from the RSA, where the infection rate is 1.62%, this is one thing, but we have a horse of quite another color if they come from the USA where the infection rate is 5.75%.
As it follows from the protocol, 164 individuals fell ill out of a total of 21999 participants, i.e. 0.745%.
The trials lasted for 3 months, having started at the end of July. According to the WHO data, a disease rate plateau was observed from July to mid-October, though a tendency for an incidence increase began to appear.
However, the rapid growth, which has been going on since mid-October, most likely was not included into the final protocol.
According to various sources, the rate of newly infected people (new cases / earth population) during the three month period of phase 2/3 was as follows:
It is obvious that the average case increase grew. In other words, the world increase during the three months was 0,12%+0,13%+0,16% = 0,42% ~ (1.5% on average in per year terms for 11 months).
Please note that this world average data includes China too where the new cases rate is around zero (according to the official information).
At the same time, the world statistics today demonstrates higher morbidity rates.
Below you will find the morbidity data for the pandemic period from March to the present (10 months):
USA 5,75% (0,575% average growth per month)
Germany 1,92% (0,192% average growth per month)
Turkey 2,47% (0,247% average growth per month)
RSA 1,62% (0,162% average growth per month)
Brazil 3,48% (0,348% average growth per month)
Argentina 3,46% (0,346% average growth per month)
At the mean 2,99% (0,299% average growth per month)
As we see, the average morbidity growth for a period of three months in these countries is almost 0.9% (versus 0.745%, presented in the Pfizer protocol).
It is also important to take into account the fact that during August, September and October the average infection rate exceeded this indicator for the year.
Today the average indicator for 10 months (March – December) is 1.03%, i.e. 0.1% growth per month.
In August, September, October the infection growth is higher, which makes it necessary to increase the average indicator calculation by country:
|Country||August||September||October||3 months total|
The implication is that the average cases increase in the reference countries is 1.21% versus 0.745% presented in the Pfizer protocol.
From this it can be concluded that the incidence data in the Pfizer protocol is more than 1.62 times lower than that recorded in the reference countries during the Phase 2/3 period.
In reality the vaccine efficacy calculated as the ratio of the infected vaccine participants to the infected placebo participants may remain at the current level of 95% (8/164), but with a linear increase of cases in one group a non-linear increase of cases in another group may take place.
All this suggests that either the reference group participants were well isolated and stayed in an epidemiologically very favorable areas where our calculations could have underestimated additional factors or Pfizer deliberately presented inaccurate data in the protocol, which was sent to the FDA.