It seems AstraZeneca cannot get a break with the EU. A wave of EU countries decided on Monday to suspend the use of the vaccine, despite the advice of the bloc’s medicine regulator, which is still investigating cases of blood clots.
On Monday afternoon, France got the dominoes running, by suspending use of the vaccine until at least Tuesday afternoon, Germany did the same indefinitely after newly reported cases of blood clots. Spain announced a pause whilst waiting for an assessment by the European Medicines Agency, with the pause lasting potentially as long as two weeks. Cyprus, Latvia, Luxembourg, Portugal, Slovenia and Sweden all followed suit.
Only Italy seemed to buck that trend, after its drug regulator announced that the vaccine was safe on Sunday.
The growing concerns over the safety of the vaccine come as countries ponder whether the benefits of the jab outweigh any potential unproven links to blood-clots, which has led to the growing consensus to wait for firmer scientific evidence. The EU regulator held to its position from last week stating that they viewed the benefits outweighing the side effects. However, the EMA’s safety committee has said it will further review the available information on Tuesday and alert member countries if further action needs to be taken.
AstraZeneca has pushed back, releasing a statement on Sunday in which it states that the number of adverse incidents have been lower than expected in the general population.
One cannot help but wonder if this is perhaps another battleground in the ongoing dispute between the EU and AstraZeneca, which first began when the latter announced that they were having production problems and may struggle to meet demand within the EU. That warning led to the infamous tearing up of the Northern Ireland protocol by the EU, to prevent vaccines getting into the UK, though the EU subsequently reversed its decision. The dispute continued when a German Newspaper claimed that the vaccine was very low in effectiveness amongst the older population segment, whilst Macron claimed the vaccine was only quasi effective.
Then came the inevitable reluctance of Europeans to have the vaccine, and Italy’s decision to block the export of 250,000 doses of the vaccine that were destined for Australia.
Furthermore, as David Spieghalter has noted, the European Medicines Agency claims that there have been ‘30 thromboembolic events’ following around five million vaccinations. Though he notes, ‘Deep-vein thrombosis happens to around one person per 1,000 each year, and probably more in the older population being vaccinated.’ Looking at the vaccines, he concludes that they have shown themselves to be incredibly safe, and says that whilst the data should be monitored, the data so far has no reason to justify an extreme action as the EU is currently implementing.
So, why is the EU adopting this approach? The precautionary principle would seem to be the answer. This principle suggests that precautionary action should be considered even before a causal link has been established by absolutely clear scientific evidence. Which would make sense if the action taken has no downsides, but in the midst of a pandemic, when there is a clear and present danger, it appears suicidal. If the vaccine is eventually cleared, it should surprise nobody if people are still reluctant to take it due to the scare-mongering that the EU has been engaged in.