On Oct 17th, 2012, on the verge of the 2012 seasonal flu vaccine campaign, the Italian Ministry of Health suddenly announced the recall of 2.3 million doses of the Inflexal V flu vaccine, produced by the Dutch company Crucell. "Potential danger" to health was claimed for the recall. This news rapidly spread with alarm.
The Ministry of Health reassured the population that security problem should not be expected because no dose was put into circulation.
Nonetheless, an instant Poll commissioned by TELL ME Project to ISPO (see below) confirmed the rising distrust of Italian people toward vaccine: 20% of the Poll sample expressed growing opposition against the flu vaccine after the announced recall. But the story does not end here.
A few days later, on Oct 24th, the Italian Ministry of Health suspended the use and sale of four other influenza vaccines, produced by the pharmaceutical company Novartis. In a statement circulated with urgency, Italian citizens were asked not to buy or use these vaccines until further notice.
The Italian Medicines Agency (AIFA), the national authority responsible for the regulation of drugs in Italy, explained that the documentation submitted by the pharmaceutical company needs to include more safety checks and more details on the safety and quality of their vaccines. Such a precautionary measure is due to the reported appearance in the vaccines of protein aggregates that could decrease their effectiveness and possibly increase the likelihood of local reactions or influenza-like symptoms, which commonly occur after administration of the seasonal influenza vaccine. Following the Italian decision, four other European Union countries – Austria, France, Germany and Spain – plus Switzerland and Canada - have temporarily suspended the use of the accused vaccines.
On Oct 31st, this suspension has been lifted in Canada and Switzerland, following further risk assessments. Both Canadian and Swiss national regulatory authorities conducted their own laboratory tests and reviewed data submitted by Novartis before taking their decisions. Less straightforward the position assumed by Italy; at the same time of Canadian and Swiss official announcements, AIFA expressed the “likelihood of taking a warily positive attitude toward the possible removal, limited to some batches, of the prohibition of use of the Novartis vaccines”. Nine days later, on Nov 9th, AIFA proclaimed that the suspension of flu vaccines had been lifted, following the accurate review of the documentation provided by Novartis and further analysis carried out by both AIFA and the Institute for Superior Public Health (ISS).
The TELL ME Project has identified in this series of events an extremely interesting case study through which to investigate the mutual interplay between medical evidence, institutional information, public health campaign, public opinion and the possible consequences of a decrease in the efficiency of such a complex, interrelated mechanism. TELL ME has then commissioned an instant poll about the impact of these facts and communication on people’s attitude towards flu vaccination. Results are presented in the following slides.