The Italian Medicines Agency (Agenzia Italiana per il Farmaco – AIFA) has decided to stop administering the Oxford/AstraZeneca covid-19 vaccine “in the whole National territory, as a precaution and temporarily, pending the pronouncements of the European Medicines Agency.” This is due to concerns about possible severe side effects. Initially (11 March 2021) the suspension only concerned a batch of 500,000 doses, of which half were delivered to Italy, and reserved mainly for the region of Sicily. At the time of writing, other European countries such as France, Portugal, Slovenia, Cyprus, and Spain have also stopped using the Oxford/AstraZeneca vaccine.
The decision in Italy, explained in a short press release from AIFA, “was taken consistently with analogous measures adopted by other European countries. Further investigations are currently underway.” AIFA, “in coordination with the EMA and the other European countries, will jointly evaluate all the events that have been reported following the vaccination.” Finally, AIFA “will promptly disclose any further information that may become available, including further methods of completing the vaccination cycle for those who have already received the first dose.”
The Agency’s decision was taken after the director—Nicola Magrini, former editor of the World Health Organization’s List of Essential Medicines, and the president—Giorgio Palù—had ruled out any connection between vaccination and thrombotic events that occurred in three vaccinated people, in different interviews with national media. The same position was reiterated by the health minister—Roberto Speranza who said: “Vaccines in Italy and in Europe are all effective and safe, but we will continue to verify and control everything with the utmost attention.”
These events are taking place in a particularly dramatic phase for the country: the third wave of covid-19 has now started in Italy (with the sole exception of the island Sardinia). The National government has ordered a new very strict lockdown. In schools, distance learning is almost mandatory: eight out of ten students will follow their lessons remotely. Remote working is compulsory for all industries for which the presence of employees in the workplace is not essential. However, as happened in 2014 with the flu vaccination—when false alarms caused a dramatic drop in the vaccination campaign and there were hundreds of thousands of hospitalizations in Italy—fear spreads rapidly and increases inappropriate reports. The events of these days jeopardize the success of the coronavirus vaccination strategy. The leaders of AIFA recommend caution in disseminating information on adverse events, while still guaranteeing transparency. They have called for media support to present the data clearly and in clear language that is easy to understand. In this context, AIFA recently released the second pharmacovigilance report with all adverse reactions reported so far.
However, the national vaccination plan could be heavily affected by public vaccination hesitancy. Even if official data is lacking, several sources are reporting cases of citizens who have given up on the vaccination programme. At the same time, the vaccination programme is challenged by the position of Italian doctors, who are worried about suffering legal consequences if citizens experience adverse side effects from the vaccine. The Federation of Italian Physicians (FNOMCeO) has engaged in an intense activity of providing information to citizens and has asked for a sort of “legal shield” for vaccinating doctors, giving them protection from criminal liability.
The national government must face—on the one hand—the regional authorities’ request for greater decision-making autonomy in the vaccination field. On the other hand, however, the crisis in the vaccination plan underlines the difficulties in coordinating European pharmacovigilance. Surprisingly, decisions to suspend the Oxford/AstraZeneca vaccine were adopted by one EU member state after the other, rather than by the European Medicines Agency.
The crisis calls for new efforts in clear and transparent communications and accurate information by all national and international authorities. We should avoid isolated and uncoordinated activities. We should tackle this new stress test for our national health service using our best practice guidance on medicines, and ensure that this does not have a detrimental effect on the vaccination rollout, at such a critical time.
Luca De Fiore, Il Pensiero Scientifico Editore.
Antonio Addis, Dipartimento di Epidemiologia del Servizio Sanitario del Lazio ASL Roma 1.
Competing interests: none declared.