When politics interferes with the vaccine surveillance process, we move to emotion informing beliefs and decisions, writes Terry Maguire

In the 1960s, US President Johnson was considering mandatory vaccination to eradicate a number of infectious diseases, but was advised against. 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, in the middle of March.

Irish health authorities made a major mistake on Monday 15 March and it could cost lives. Prof Karina Butler, chair of the National Immunisation 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.”

Abundance of caution! It could be straight from WB Yeats or Seamus Heaney. The European Medicines Agency (EMA), which advises the Health Products Regulatory Authority, did 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 37 blood clotting events in patients recently vaccinated. The World Health Organisation agreed there is most likely not causal link.

Social media noise

A month previous, there was much social media noise in the US about deaths linked to Covid-19 vaccines. The FDA investigated 1,117 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 normal expected number of deaths, but the damage had been done. The anti-vaxx websites were alight and the conspiracies multiplied.

The day this controversy hit the news, and before Ireland suspended the vaccine, I had three phone calls to the pharmacy, 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. Logical, but wrong.

The deferment of 30,000 AZ vaccinations was a mistake as there was no link. The 37 clotting events (15 deep-vein thrombosis and 22 pulmonary embolisms) identified events will be fully investigated, as each of the 1,117 deaths in the US were investigated. This is the process, but 37 events from 17 million is a rate of 0.007 per 1,000 and, as one commentator suggested, the contraceptive pill has been shown to cause clotting at a rate of 0.06 per 1,000 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. Ironically, in this population size there would be 350 events expected in a month, so it could be argued that, using these figures, the vaccine is stopping clots.

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

Then the EMA announced there was no link and European countries, including Ireland, resumed their vaccination programmes. But the damage had 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.

Efficacy

The EU has had an issue with the AZ vaccine from the start that is political, not scientific. German media, at the time it was being approved, reported that the vaccine was only 6 per cent effective in the over-65 age group. This was completely wrong and it seems the 6 per cent figure came 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.

Post-marketing 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.

But when politics, implicit or explicit, interferes with this surveillance process, we move to emotion informing beliefs and decisions. Too many people across the EU had their vaccination schedules delayed, too many people decided not have the vaccine at all because of perceived yet non-existent risk and sadly, some people will contract Covid-19 in the third surges raging in the EU, will die and in some cases, the cause will be clotting as a complication of Covid-19.

Irish medicine authorities must work extra hard explaining to the population that they were too hasty in adopting their “abundance of caution” and that, frankly, they made a mistake and they wish to apologise.

Terry Maguire
Terry Maguire

Terry Maguire owns two pharmacies in Belfast. He is an honorary senior lecturer at the School of Pharmacy, Queen’s University of Belfast. His research interests include the contribution of community pharmacy to improving public health