Precautionary suspension of Novartis’ influenza vaccine in some European countries

Five European Union countries, plus Switzerland and Canada, have temporarily suspended the use of some batches of an influenza vaccine manufactured by Novartis. Medicines regulatory authorities have taken this precautionary measure because of the reported appearance of protein aggregates in the vaccines. The vaccines were manufactured in the Novartis production plant in Italy and are marketed under different commercial names, including Agrippal, Bergripal, Chiroflu, Chiromas, Fluad, Influpozzi and Sandovac.

Such regulatory action is a standard measure to allow time to investigate quality and safety once a specific concern is raised. No added risk has been observed in people who have already received the vaccines. Generally, protein aggregates in the vaccine could theoretically increase the likelihood of local reactions or influenza-like symptoms, which commonly occur after administration of the seasonal influenza vaccine.

Quality assurance processes at the manufacturer level and regulatory oversight ensure the quality, safety and efficacy of products for human use. Production of vaccines is a highly controlled but complex process, and inherent variability can occur. WHO recommends the use of influenza vaccines that are produced according to international standards and are authorized for marketing by national medicines regulatory authorities.

Seasonal influenza may occasionally cause severe complications, particularly among elderly people and people with underlying medical conditions. The risks of complications and severe outcomes should not be underestimated in considering the potential risks of vaccination. Immunization saves lives, and the cost of the disease is indisputably much higher than the cost of prevention.