It is expected that this Thursday the Committee for the Evaluation of Risks in European Pharmacovigilance (PRAC) of the European Medicines Agency (EMA), will formally pronounce, after the analysis of the cases reported with “rare events of thrombi” after receiving the doses of AstraZeneca, and according to Darias the decision will be binding for Spain although before resuming vaccination, if it is the case, it will call again the heads of Health of all the autonomies.
“We agreed to wait at least 14 days, but it does not mean that we have to wait the 14 days. Our intention is that as soon as the PRAC makes a decision, it will convene another inter-territorial council starting tomorrow because we believe in co-governance and shared decisions.
In this regard, he stressed that the vaccines approved by the European Agency are “Safe and effective and save lives”, and that precisely because the pharmacovigilance system works and alarms have gone off in neighboring countries, it was suspended on a precautionary basis until the analysis of the cases. “Until now, a temporary relationship has been established, but not a causal one, we must wait for the PRAC to pronounce itself,” he insisted.
Asked about a possible vaccination plan B given the hypothesis that AstraZeneca would be excluded, the minister was blunt. “There is no other plan in principle, we have to wait for what the PRAC says”, the Committee of the European Medicines Agency, but the “group vaccination strategy is the one agreed upon in the Public Health commission”, he settled. “Let’s wait for the response this Thursday to continue advancing in the process and building trust. The pharmacovigilance system is rigorous – he emphasized – and reports data on adverse health effects, related or not to the vaccine.
On the other hand, and although the data on infections generally continue to decline, the national head of Health warns about a “possible change in trend” because some communities have started a “slight rise”, which generally translates into that we are in a “valley area, stagnant,” he warns.
Claim, therefore, «Prudence» to «avoid a fourth wave»Like the one that already appears in neighboring countries such as France or Italy. In this sense, he recalled that the agreed measures on perimeter closures and mobility limitations are carried out, and warned that he is seeking consensus to avoid public attendance on the occasion of the celebration of the Copa del Rey de Fútbol in Seville, « Even if the capacity is limited, it is not possible, it is not reasonable or adequate, ”he stressed.
The death of a teacher in Marbella, under magnifying glass
The death of a teacher from a Marbella institute, who suffered a thrombosis and had been administered the AstraZeneca vaccine, joins the other two cases being investigated in Spain “about 975,671 vaccinated” with these doses, emphasizes the minister. The European agency, which continues to analyze the cases, reiterated yesterday that the benefits of this vaccine are greater than the associated risks, according to the data known so far, and the World Health Organization (WHO) recommended continuing with its administration.
Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.