Why Safety Concerns Should Get More Attention in COVID Vaccine — Lessons from A Comparative Study | Bharat Dogra

COVID-19 vaccines have been widely discussed, but still safety aspects need more attention. Generally in the case of all vaccines adverse events recorded constitute an important part of discussion relating to them, and this is all the more so in the case of COVID-19 vaccines which were developed and distributed in unprecedented hurry.

A comparative review of adverse impacts of COVID-19 vaccines is attempted here at two levels. Firstly in the case of a single country (USA) where comparable data over a time period of several years is available, the adverse events following all other vaccines are compared with adverse events following COVID-19 vaccine during 2020-21.
Secondly the adverse events data for COVID vaccines is compared for various countries, particularly the USA and India, but also bringing in several European countries and China to some extent.

First, we can compare the official data for per month deaths following COVID vaccines with the longer-term data from the same comparable official source for per month deaths following all other vaccines in the context of the USA. The source of all this data is VAERS (Vaccine Adverse Events Reporting System) which has been recording adverse events, serious injuries and deaths following vaccinations for several years in the USA.

There have been criticisms, supported by studies, that what gets recorded in VAERS may be very substantial under-estimates but still it is the only officially recognized data base we have in the public domain. VAERS figures do not establish a cause and effect relationship. This data base only tells us that a certain number of adverse events including deaths were reported and recorded in this system within a certain specified number of days following vaccination. The same is also true of the data on adverse events of other countries later in this review.

The VAERS data inform that for the roughly sixteen and a half year period ( 198 months) from July 1997 to December 2013, counting all the various vaccines that are administered in the USA, many adverse events were recorded which included 2149 deaths. This figure is available in a paper titled Deaths Reported to the Vaccine Adverse Event Reporting System 1997-2013, United States, authored by Pedro L. Moro, Jorge Arana , Mario Cano and others. This paper, ( Clin. Infect. Dis 2015 Sep.15; 61(6), reproduced by National Library of Medicine, National Center for Biotechnology Information is based on what was recorded in VAERS. This paper also says that these deaths showed a declining trend.

Dividing 2149 by 198 we find that on average per month 11 post-vaccine deaths were recorded, counting all the various vaccines administered in the USA.

Now let us look at the post-vaccine deaths recorded only for COVID-19 vaccine in the USA under the VAERS since this vaccination started in December 2020. During the roughly 11 months period from December 14 2020 to November 12 2021, a total of 8,664 deaths were recorded This works out to an average of about 788 deaths per month.

Thus we learn that the number of post-vaccine deaths recorded per month for COVID-19 vaccine up to November 12 2021 (788) is about 72 times of the deaths per month that were recorded earlier for all vaccines combined (11), as revealed in a longer-term study of VAERS records for 198 months, years 1997-2013.

While calculating this we have used the much lower VAERS estimate which excludes deaths following COVID vaccine attributed to ‘foreign reports’. However if a calculation based on those official estimates which include ‘foreign reports’ is made then the number of deaths recorded up to November 12 is 18,853. This means an average of 1714 deaths per month or 156 times the deaths recorded for all vaccines per month earlier.

During the period of about 11 months December 14 to November 12 following COVID-19 vaccine, in the VAERS system of USA, after excluding foreign reports, a total of 654,413 adverse events and 54,962 serious injuries were recorded. If we include foreign reports the numbers are significantly higher at 894,145 adverse events and 139,126 serious injuries.

These easily verifiable statistics, as also the findings of important studies that VAERS data on adverse side effects should be treated as substantial under-estimates, should have clearly got more attention in official decisions, as also the hardly discussed possibility of adverse impacts that may manifest much later. People should be adequately informed for a proper democratic debate to take place.

Now in the second part of this review let us try to compare the USA data with the data for some other countries. The USA data is up to around mid-November when around 410 million vaccines had been administered. In India up to this time about 1100 million vaccines had been administered. However the adverse events following COVID-19 vaccines as reported officially are very, very less compared to what has been reported for the USA. As reported in leading newspaper the Hindu November 29 the serious adverse events following COVD-19 vaccine till November are 2116. ( See report titled Vaccination adverse events less than 0.01%, Centre tells Supreme Court, written by Krishnadas Rajagopal).

As available data indicates adverse events data to be amazingly below that for the USA, there can be two interpretations. One interpretation can be that in terms of safety the COVID Vaccination in India has been enormously superior compared to the USA. This would be appear to be all the more so keeping in view that VAERS estimates also involved substantial under-reporting. The second interpretation is that the data on this subject is a huge underestimate of the actual situation. Which interpretation appears more acceptable to readers?

In the case of China, as in the case of India, the real situation in this context is not clear and more transparency is needed. However a Bloomberg report dated May 28 titled ( China says it has about 0.01% adverse events from COVID vaccines may be mentioned here. This report mentions the figure of 31,434 adverse events from 265 million jabs administered till then. If we extrapolate the same figure for the nearly 2300 million jabs given till the last days of November, ten w get a figure of about 280,000 adverse events (these are not described as serious adverse events, just adverse events in the Bloomberg report.). Comparing with the adverse events in the USA and other western countries, this again is a substantial underestimate.

In the case of nearly 27 countries of the European Union, an analysis of adverse events as reported in Health Impact News dated 28 November mentioned 31000 deaths, 2890,600 injuries including 1355,192 serious injuries.

Hence the trend appears to be of high reporting from developed countries and of low reporting from developing countries. Another important aspect relates to extension of COVID-19 vaccination to teenagers and children and voices of caution voiced by several senior scientists in this context. In fact In India almost as soon as the official announcement in this context was made, on December 6 2021 a senior epidemiologist of AIIMS Dr. Sanjay K. Rai, President of Indian Public Health Association and involved in Covaxin trials in India in a very senior position, stated that this will not yield any additional benefits. At the world level Dr. Robert Malone, who has played a very important part in the debate, has warned against high risks involved in this. He has stated that thousands of scientists and doctors oppose this (Physicians Declaration II-Updated October 29 2021, Global COVID Summit, International Association of Physicians and Medical Scientists). Dr. Malone is discoverer of in-vitro and in-vivo RNA Platform and architect of mRNA Vaccine Platform. Hence his views and those of several other senior scientists should not be ignored. In the interests of ensuring safety and avoiding any adverse impacts it is important to resolve these controversies in such a way that the health and safety concerns of all and particularly of children are well protected.

(The writer is Honorary Convener, Campaign to Save Earth Now. His recent books include Man Over Machine and Protecting Earth for Children)