Tuesday , August 3 2021

Are Astra Zeneca Vaccine Reactions a Scapegoat for the EU?

I once spent several months operating the adverse reactions database for a major pharmaceutical company.  Most drugs and vaccines had at least one death associated with their use such as anaphylaxis or skin rashes so terrible that the patient died.  When millions of people are exposed to any novel substance a very few will react adversely and some of these will die.  The important issue is whether the drug etc. is of significant benefit despite a very low risk of severe adverse reaction.

Most people occasionally take paracetamol (acetaminophen).  It is freely available at pharmacists and regarded as one of the safest oral medicines.  If we take a look at adverse reactions in the European adverse reactions database (called Eudravigilance) paracetamol caused 58 deaths from adverse reactions in Europe over an 11 year period. It also causes hundreds of deaths through suicide annually.

Aspirin use causes 15 deaths per 100,000 users per year so even my hangover cure can be deadly.  Adverse reactions in the EU are estimated to cause 200,000 deaths a year. This is about 45 deaths per 100,000 population and, given that maybe half the population is taking medicines during the year, about 90 deaths per 100,000 medicine takers.

The current mass vaccination program means that a vast number of people are being exposed to a new therapy.  In the week or two after vaccination doctors will be inclined to report any interesting cases passing through their surgery as possible adverse reactions.  This combination means that scurrilous journalists have plenty of fodder to create fake news to sell broadcast time and papers.  What are the facts?

Any increased incidence of blood clots with the Astrazeneca vaccination seems to be slight if present at all.  The latest Danish report states that:

“Here, based on pre-pandemic incidence rates from the entire Danish population, we report that the number of venous thromboembolisms reported in relation to the Oxford–AstraZeneca COVID-19 vaccine does not seem to be increased beyond the expected incidence rate.” (Lancet)

In my experience of pharmaceutical companies AstraZeneca’s own adverse reactions database will be a reliable source of data.  AstraZeneca has said 37 blood clots have been reported out of more than 17 million people vaccinated in the EU and Britain. Five of the cases were deep vein thrombosis, and 22 were pulmonary embolisms. “This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed covid-19 vaccines,” (BMJ).

Some of the AstraZeneca blood clots involved 22 reports of cerebral venous sinus thrombosis (CVST) and 8 reports of other thrombosis events with low platelets, these did not occur with the Pfizer vaccine.  Four of the CVST patients died. It is surprising that no reports of these rare blood clots have been submitted for the Pfizer vaccine given that there is a background level of them happening without vaccines.

By mid March about 9 deaths had occurred globally from the rare type of blood clots in the period after receiving the AstraZeneca vaccine.  A new report today from the European Medicines Agency has increased the number of deaths from rare clots to 18.  If we assume that all of these deaths were due to the vaccine it would mean there is a death rate of approximately 0.8 per million vaccinations, 0.08 per 100,000.  The risk of death from taking aspirin would still be 165 times greater than from these blood clots after vaccination. However, as stressed by AstraZeneca and the Danish study above, we would expect 9 deaths  from these blood clots in the vaccination period even if no vaccine were given although it is still possible that the vaccine has an effect. The good news is that the rare clots are treatable and now that physicians have been alerted there should be fewer fatalities.

The official government figures for AstraZeneca adverse reactions can be found at: “COVID-19 vaccine AstraZeneca analysis print” and those for Pfizer/BioNTech at “COVID-19 mRNA Pfizer- BioNTech vaccine analysis print“.  There were 283 deaths after Pfizer vaccinations and 421 deaths after AstraZeneca vaccinations by 21st March. Given that more AstraZeneca vaccinations have been given than Pfizer (now about 50% more) the two vaccines are almost identical for reported deaths. It is very important to understand that these adverse reaction reports are just recording events that happened after vaccination, they may or may not have been due to the vaccine.

 

It is surprising that the headlines have not focussed on the Pfizer vaccine. Adjusting for numbers of vaccinations by multiplying the Pfizer figures by 1.5, the “apparent risk” of sudden death was  50% higher with the Pfizer vaccine, there were 6 adjusted deaths from diarrhoea in the Pfizer group and none in the AstraZeneca group, the combined risk of myocardial infarction/cardiac arrest was 50% higher in the Pfizer group and to top it all  the risk of death from COVID19 was 300% of that found with AstraZeneca (14 versus 42, adjusted).   But the headlines would be wrong.  There is not enough data to be sure that these are vaccine specific problems and, like the blood clot issue with AstraZeneca, even if the deaths were due to the vaccine the risk is very low.

Although careful studies, such as that in Denmark, should put us at ease about the AstraZeneca vaccinations the media furore will distort everything.  When I was working on adverse reactions one of the drugs became part of a media storm and the number of adverse reaction notification events for the drug rocketed.  Doctors and patients had become hypervigilant.  The notifications for deaths slightly increased and the other notifications came in like confetti.  The same thing will now be happening with the AstraZeneca vaccine – if the patient has a minor clot a month after a Pfizer jab the doctor will not report it but if they have had an AstraZeneca jab it will definitely be reported.  We can see this already with the sudden escalation of yellow cards (adverse reaction reports) submitted for AstraZeneca.

The obvious course of action is to ensure that those at highest risk from clots should be given the Pfizer/BioNTech vaccine.  However, what if they suffer a higher risk of heart attacks or some Pfizer specific reaction as a result?  This meddling by the media in medical procedures is very dubious.

AstraZeneca and Pfizer seem to have a very similar overall figure for deaths from adverse reactions yet AstraZeneca is being crucified in the mass media.  The death rate for either vaccine is, according to the highest possible estimate, about 35 per million or 3.5 per hundred thousand doses.  They are 4 times safer than taking an aspirin.  Even if all of the deaths from blood clots were due to the vaccines they would still be safe.  Yet the mass media are whipping the population into hysteria about AstraZeneca.  Something is seriously wrong here.

 

The data shows that both of these vaccines are safe yet EU countries are banning the AstraZeneca vaccine and undermining confidence in it globally.  There can be no doubt at all that this is political.  It is a cover for the very slow and inefficient vaccine roll-out by the EU.

Journalists and editors should be deeply ashamed of their reporting of the vaccine roll-out.  Especially the BBC which is supposed to investigate news in depth.  The key point here is that even if all of the rare clotting events were due to the vaccine they are not sufficiently frequent to withdraw it.  This leaves only one story: “failing EU blames AstraZeneca for its mistakes”.

The journalists who cover this as a vaccine scare are killing thousands of people and are far more dangerous than any vaccination.

Postscript: the UK government has just publicly announced that it will not give AstraZeneca vaccines to the under 30 year old group. This decision was based on 3 deaths occurring in this group.  Given the intense media scrutiny the government was unable to quietly implement this change.  The result of this highly public decision may be to largely remove AstraZeneca as a vaccine for global use.

 

The AstraZeneca vaccine is around £4 a dose, Pfizer around £15, Moderna £13, Sputnik £10.  Pfizer needs specialised handling and Moderna needs cold storage facilities.  (See The Week)

Lets hope our mass media are proud of what they done.  It is almost certain that most of the other vaccines will have rare, but specific adverse reaction issues in the future but by the time these are discovered it will be too late. This public execution of the cheapest and easiest of the vaccines by the media will kill thousands.

Perhaps now the mass media can take down the Pfizer vaccine. Adjusting for numbers of vaccinations by multiplying the Pfizer figures by 1.5, the “apparent risk” of sudden death was  50% higher with the Pfizer vaccine, there were 6 adjusted deaths from diarrhea in the Pfizer group and none at all in the AstraZeneca group, the combined risk of myocardial infarction/cardiac arrest was 50% higher in the Pfizer group (15 extra deaths) and to top it all  the risk of death from COVID19 was 300% of that found with AstraZeneca (14 versus 42, adjusted). The problems are at least as bad as those for the AstraZeneca vaccine (ie: no real problem).  Go for it, you evil journalists!

Anyway, ITV journalists are running a documentary tonight on preventing one or two of the 14 or so deaths of women on Britain’s streets each year because they care so much for human life.

This post was originally published by the author on his personal blog: https://pol-check.blogspot.com/2021/04/are-astra-zeneca-vaccine-reactions.html

About John Sydenham

Dr John Sydenham has worked in International Pharmaceuticals and for one of the "big four" International Consultancies. He ran a successful company for 15 years and after selling the company devotes his time to travel, science, black labradors and freedom.

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