In the 1960s, US President Johnson was considering mandatory vaccination to eradicate a number of infectious diseases but was advised against it. The move would, he was told, cause 30,000 cancer deaths and 100,000 heart deaths. The President asked how the advisor knew this to which the adviser replied that this was the annual number of deaths from cancer and heart disease in the US but with mandatory vaccination, each one would be causally linked to a vaccine. This was a powerful insight but not one that has been informing the actions of many European countries including Ireland this week.
Irish health authorities over the weekend made a major mistake and it could cost lives. They have deferred the use of the AstraZeneca vaccine on a temporary basis as a precaution. On Sunday Professor Karina Butler chair of the National Immunization Advisory Committee was quoted in a statement on the organisation’s website;
The vaccine is proven to be very effective against severe Covid-19 disease, which is associated with a risk of clotting events………We have taken this step [to defer use] out of an abundance of caution”
The European Medicines Agency (EMA) which advises the Irish medicines regulator the Health Products Regulatory Authority do not view the need for a precautionary stoppage in vaccination confident in the safety and efficacy of the AZ vaccine while it undertakes an assessment of some 37 blood clotting events which occurred in patients recently vaccinated. The World Health Organisation agrees.
A month ago, there was much social media noise in the US about deaths linked to Covid-19 vaccines. The FDA, the American medicines regulator, investigated 1117 deaths in people who had a vaccine within a few days of death. Given that there were some 40 million vaccines administered in the US at that time and the majority of those were to the elderly and the clinically vulnerable it was quickly established that this was the normally expected number of deaths but the damage had been done. The Anti-vaxx websites were lit up and the conspiracies multiplied.
Last Saturday morning, before the decision by Ireland to suspend the use of the AZ vaccine, I had three phone calls each from people asking if the vaccine was safe for them as they were taking aspirin. This is logical thinking; If I’m taking aspirin to avoid blood clots then I have a blood clotting problem and if the vaccine causes clotting it is more dangerous for me.
The deferring of 30,000 AZ vaccinations this week in the Republic is a mistake. It is a mistake in that, as yet, no causal link exists between blood clotting and the use of the vaccine. The identified events will be fully investigated as each of the 1117 deaths in the US were investigated. This is the process but 37 events from 17 million is rate of 0.007 per 1000 and, as one commentator suggested the contraceptive pill has been show to cause clotting at a rate of 0.06 per 1000 and that, it seems, is totally acceptable. The Contraceptive Pill is causally linked with blood clotting the vaccine is not but Covid-19 has clotting as a serious complication of the infection.
It is likely that later this week EMA will announce the lack of causality and European countries including Ireland will resume their vaccination programmes with the AZ vaccine. But the damage has been done. Medical authorities in many EU countries including Germany, France and Italy will have converted those with vaccine hesitancy into anti-vaxxers if only against one of the Covid-19 vaccines.
The EU has had an issue with the AZ vaccine from the start that goes way beyond the science. German media, at the time it was being approved, reported that the AZ vaccine was only 6% effective in the over 65 age group. This was completely wrong and it seems the 6% figure comes from the number of over 65-year-olds in the clinical trial of 24,000 patients. Its efficacy in this age group has since been established as equivalent to younger age groups. France was too quick to echo the German concerns on efficacy even when German authorities were attempting to clarify the media error.
Postmarketing surveillance of all new medicines allows for the identification of very rare side-effects. This is vital for public safety and this is happening for covid-19 vaccines. This work must be allowed to proceed and if there are side-effects as yet undetected then decisions should only be made on the science involving often complex statistical evaluations. But when politics, implicit or explicit, interferes with this surveillance process we move to emotion and culture informing beliefs and decisions. Too many people across the EU will have their vaccination schedules delayed, too many people will decide not to have the vaccine at all because of perceived yet none existent risk and sadly some people who will contract Covid-19 in the surges that are currently raging in some EU countries, will die and in some cases, the cause will be clotting as a complication of Covid-19.
The Irish Medicine Authorities must promptly reverse their decision to delay and get to work explaining to their population that they were too hasty in adopting their abundance of caution.
I am a pharmacist in Belfast.