Several European countries have stopped using Novartis’ influenza vaccines due to a suspected ‘quality defect’.
The suspected defect involves the aggregation of proteins that are a normal part of the vaccines Agrippal and Fluad. Novartis said that these particles can occur in the vaccine manufacturing process and was “confident that there is no impact on the safety or efficacy of the vaccine”.
As the vaccines are manufactured in Italy, The Italian Medicines Agency (AIFA) was first informed of the suspected quality defect by Novartis earlier this month that there could be a problem with the manufacture of its two vaccines.
The Italian regulator then alerted all other EU countries, with the local Swedish, German Spanish and French drug regulators also stopping the sales of the vaccines.
The European Medicines Agency was keen to stress that these regulatory actions are precautionary, since so far there is “no indication that this suspected quality defect has any impact on the safety or efficacy of the vaccines in question”.
But the European regulator has no formal legal role in this case, as the products are nationally authorised, meaning it will only be taking a ‘supporting role’ in the process.
AIFA will be taking the lead on behalf of the EU in investigating the suspected quality defect in order to determine whether it affects the safety and efficacy of these vaccines, and whether the affected batches should be permanently removed from the market.