EMA Reassures Safety of Novartis Flu Vaccine

December 4, 2014

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

EMA has reported that there is no evidence that the flu vaccine (Fluad) made by Swiss drugmaker, Novartis, caused deaths in Italy after a review by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC).

On November 27, 2014, two batches of the vaccine were suspended by Italian regulators as a precautionary step following the death of four elderly people (two women and two men aged between 67 and 87) after they were given the vaccine. PRAC has reassured EU member states that these cases are not related to the administration of the vaccine.

Fluad is authorized in the EU for use in the elderly, particularly those with multiple illnesses and who are at a higher risk of health complications. Approximately 4 million doses of the drug were distributed as part of a current flu vaccination campaign in Italy. Other countries, including Austria, Germany, and Spain, have also used Fluad in their annual flu vaccination campaigns.

Source: EMA