The European Medicines Agency (EMA) announced Wednesday that it had found “possible links” of causality between AstraZeneca’s vaccine against covid-19 and a severe form of thrombosis seen in vaccinated people. The frequency of this rare adverse effect is so low, however, that it does not justify stopping the vaccine, according to the European authority. The EMA pharmacovigilance committee has analyzed 84 cases of thrombosis, of which 18 were fatal, reported by 16 EU countries, and its conclusion was clear: the benefits of the vaccine far outweigh the possible risks. Despite this, it is evident that the recognition of the likelihood of the link and the unknowns that surround the adverse events generate concern in the public. It is therefore essential that the political and scientific authorities handle this whole issue with the utmost care so as not to undermine the confidence of the population in a tool that continues to be essential in the fight against the pandemic, and bearing in mind that there are not yet sufficient supplies.
It is essential to establish the necessary strategies to continue using this tool wisely. It is important that on the road ahead these guidelines are as consistent as possible in Europe, in the light of the scientific evidence of each moment, to avoid distortions and the spread of an unjustified fear that causes rejection of the vaccine. Since the exact mechanism that generates this rare adverse reaction is not yet known, it is difficult to establish firm exclusion criteria that increase safety. That must now be the priority of pharmacovigilance teams. At the moment, it is known that the majority of those affected are women and are under 60 years of age. According to this data, the Ministry of Health and the communities – opposed by Madrid – took a radical turn and agreed to paralyze the administration of the vaccine to those under 60 years of age until new evidence is obtained. Italy took the same step. Germany already had the same pattern in force, and France a similar one. EU sector ministers failed to agree on a general common pattern. Hopefully there may be convergence in the future. In any case, you must remain calm – there is no scientific reason for nervousness, much less panic – and avoid making hasty decisions, such as that of Castilla y León, which suspended vaccination. Acting unilaterally does not guarantee a better result and instead creates mistrust.
No drug is completely safe. The question is whether the benefits it brings outweigh the risks inherent in its use. And in this case the scientific evidence provided by the EMA says that it is. Do not forget that this vaccine has proven to be effective in preventing severe cases. In the current context of growing infections and limitations in vaccine production, radically giving up AstraZeneca could end up causing far more deaths than would be prevented by discontinuing its use. We will have to measure well between prudence and the risks of hyperreaction.
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