Once again the COVID-19 vaccine, specifically the AZ (AstraZeneca) vaccine, has been dominating the news headlines this week.
The suspension of its use by multiple European nations comes as their case numbers continue to rise with scientists warning that a third wave of the pandemic is imminent across Europe. In contrast to this, cases and deaths continue to fall in those countries who have been the fastest to roll out their vaccination programmes including the UK, Israel, USA and UAE. (1)
The suspension was driven by fears that the vaccine could be causing potentially fatal blood clots. What is rarely reported is the fact that COVID-19 itself causes blood clots and at frighteningly high levels. (2)
A Dutch study found that almost half of all COVID-19 patients on Intensive Care had a blood clotting complication. Other studies have shown that up to 30% of seriously ill COVID-19 patients develop a clotting problem. Blood clots are a major cause of death in people with COVID-19. (3)
What does “Blood Clotting Disorder” mean?
Blood clots can occur in any part of the body and for different reasons.
The main purpose of clotting is to stop bleeding from injuries, it is why the bleeding stops when you cut yourself. This is normal, healthy clotting.
One of the most common blood clot disorders is a deep vein thrombosis, or DVT. These classically occur in the calf and are a known risk in a variety of situations from pregnancy to flying long haul.
Blood clots can form in the lungs, known as a pulmonary embolus or PE, either spontaneously or small clots from a DVT can break off from the main site in the calf and travel up and into the lungs. A PE can be treated but is a very serious condition that can sometimes be fatal.
The incidence of both DVTs and PEs varies with ethnicity (White and Black people have higher rates than Hispanic and Asian people) so there is not one global figure for occurrence.
In the USA there are 5 cases of DVTs or PEs per 100,000 children per year aged under 15 and this raises steadily with age to a rate of 500 cases per 100,000 people aged over 80. Roughly one third of all patients regardless of age present with a PE and two thirds with a DVT. (4)
In the UK the annual incidence of both DVTs and PEs combined is approximately 1 to 2 in 1000 people across all ages. As with the USA the risk rises substantially with age; for people aged 40 and under the risk is 1 in 10,000, whereas for people over 80 years it is 1 in 100. (5)
A very rare type of blood clot known as a cerebral vein sinus thrombosis or CVST can occur in the brain. CVST affects about 5 people in 1 million each year and is sometimes seen even in new born babies and children. Five of the clots in vaccinated people recorded in the UK were of this type. (6) (7)
The Story behind the Suspension
The media has led with stories such as “AstraZeneca vaccine may be linked with blood clots” and “Europe pauses using AstraZeneca vaccine amidst fears it could cause blood clotting issues.”
Austria was the first country to raise an alert on 7 March 2021 when one patient died and another was hospitalised (but fully recovered) from a blood clotting disorder. Both had been vaccinated in the preceding days.
Denmark reported one similar death on 10 March 2021 and became the first country in Europe to suspend the use of the AZ vaccine on 11 March 2021 pending further investigation.
Norway announced their suspension three hours after Denmark's announcement citing new reports of clotting problems in three people.
Germany initially announced it would continue to use the AZ vaccine but then backtracked on this on 15 March 2021 whilst it looked further into seven cases of clotting problems amongst its population.
Italy announced its suspension the same day as Germany citing the identification of one case of a fatal blood clot in an Italian man who had recently been vaccinated. (8)
Spain also suspended the vaccine after identifying one case of a blood clot in a patient who has since recovered. (9)
Iceland, Bulgaria, Ireland, The Netherlands, France, Cyprus, Portugal, Latvia, Slovenia, Sweden and Luxembourg announced their own suspensions over the next two days.
None of these 11 countries have identified clotting problems in any of their own citizens who had received the AZ vaccine. (10)
On 18 March 2021 both the UK’s drug regulator the MHRA , The Medicines and Healthcare Products Regulatory Agency, and the European regulator the EMA, European Medicines Agency, announced that after analysing all the available data from each country, the AZ vaccine was safe.
France, Germany, Spain and Italy all announced they would resume using the AZ vaccine immediately. (11)
The regulators also looked at cases of clotting disorders in people who had received the Pfizer vaccine and found similar numbers as with the AZ vaccine. Whilst episodes of severe clotting problems were found with both vaccines only the AZ vaccine became the focus of attention. This happened despite scientists drawing attention to the fact there were no differences between the two vaccines. (12)
The European suspension went ahead against the advice and recommendations of both the EMA and WHO (World Health Organisation). (13)
It seems to have been the occurrence of some of the rare CVST blood clots that prompted countries to suspend vaccination.
Spain’s director of the Spanish Medication Agency, María Jesús Lamas, said her country’s thinking changed after a report of the rare blood clot in the brain. Germany, which originally planned to continue vaccinating, decided to pause it after identifying seven possible cases of CVST out of 1.6 million people who had been vaccinated. French officials said they had based their decision on the German data.
Overall there were 30 reports of blood clots of all types out of 5 million people who had received the AZ vaccine across Europe and 7 reports of blood clots in the UK from a total of 11 million people vaccinated with the AZ vaccine. (14)
The UK’s MHRA advised that vaccination with the AZ vaccine should continue with Phil Bryan, the head of the MHRA, pointing out that the reports of blood clots did not exceed what was expected to occur naturally.
Professor Stephen Evans from the London School of Hygiene and Tropical Medicine, described the decision to suspend the vaccine in some countries as “a super-cautious approach based on some isolated reports in Europe”.
The UK did not suspend its use of the AZ vaccine. (15)
Putting the Numbers in Context
The problem with compiling individual case reports, particularly when the patients involved are seriously ill or sadly die, is that it can cloud the overall picture.
Professor Penelope Ward from King’s College London reviewed the data and explained it this way:
“In the UK, about 165 people a day might suffer a thrombotic [blood clotting] episode, some of which will be fatal. In contrast, the number of reports from the ongoing vaccine programme in the UK and EU, which includes [more than] 20m individuals vaccinated to date, is just 37. By chance alone, at least 15,000 such events might have been expected from a population of that size.” (16)
In fact it would be completely legitimate to argue from these statistics that the vaccine is decreasing the chances of having a clotting event. As Ann Taylor, AstraZeneca’s chief medical officer, said: “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population.” (17)
The Concept of Risk
In the piece here I said the following:
“Decisions are made by balancing the risks, something people do every day without realising it. Although a car journey could result in an accident, a walk could result in a fall and a broken leg or a trip to a restaurant could result in food poisoning, these are familiar risks and people are able to balance them and make reasoned decisions. They know that it is far more probable they will not have an accident, break a leg or get food poisoning.
The same is true with illness and disease. We send our children to school knowing they will be exposed to coughs and colds, chickenpox and various other childhood ailments. We take holidays in far flung places knowing they expose us to diseases that we never encounter at home such as malaria. However, what marks these apart from COVID-19 is they are known risks we feel familiar with and we know how to manage them. Coughs and colds are simply a part of life and we can be vaccinated against many serious illnesses before going abroad.
The difference with COVID-19 is that it is new. Just over a year ago none of us had heard of it but in that time is has brought entire nations to a standstill.”
Any doctor who says any drug or procedure is completely risk free would be lying. The whole of medicine (and life) involves risks.
What matters is does the benefit outweigh the risk? And ideally outweigh the risk by a significant and substantial amount?
The reality is that COVID-19 is a highly infectious, potentially fatal disease. It has killed more than 2.6 million people worldwide, including 126,000 in the UK alone.
Oxford University have a COVID risk calculator that can be used for research purposes. (18)
It allows you to input data about age, BMI (body mass index) and underlying health conditions to see what the relative risk of COVID-19 for that person is.
Using this calculator I put my own data in and was told that my estimated risk of becoming seriously ill to the extent that I would need hospital admission if I contracted COVID-19 would be 1 in 2017.
If seriously ill with COVID-19 my risk of having a blood clotting event could be as high
as 1 in 3.
The AZ vaccine was suspended because of the finding of 37 clotting episodes in 17 million vaccinated people.
That equates to a risk of 1 in 459,460 of having a clotting event post vaccination.
I am 227 times more likely to end up seriously ill in hospital from COVID-19 infection then to have an adverse blood clotting reaction because of the vaccine.
In Conclusion
It must always be remembered that the very thing the vaccine is trying to prevent - COVID-19 - is a harmful, potentially fatal illness in and of itself. We are not weighing up a 37 in 17 million chance of getting a blood clot against a zero chance of getting one. We are weighing it up against the risks of not being vaccinated at all and becoming seriously ill or dying from COVID-19.
The risk of not having the vaccine outweighs the risk of having it by hundred folds.
The cancellation of people’s vaccinations has in reality potentially increased their risk of getting a blood clot because they will remain unprotected for longer against COVID-19, a far more potent cause of blood clots.
I fear that the past week has seen a combination of media hysteria, misrepresentation of the facts and political pressure that will have done immeasurable damage to the vaccination programme worldwide.
(8) https://www.theguardian.com/world/2021/mar/15/germany-suspends-oxford-vaccine-over-blood-clot-fears
(13) WSJ 17 Mar AstraZeneca Covid-19 Vaccine’s Benefits Outweigh Risks, Says EU Updated March 16, 2021 11:20 am ET
(14)WaPo 16 Mar Why European countries have suspended AstraZeneca’s coronavirus vaccine
(18) https://qcovid.org/
