Last week the Italian Ministry of Health (AIFA) ordered the Swiss drugmaker to halt the distribution of two of its seasonal influenza vaccines – Agrippal and Fluad – after tests showed that one batch of the latter product contained protein 'particles.'
In a statement Novartis said it is confident the two vaccines - manufactured at the Novartis Vaccines and Diagnostics’ Rosia site near Bellaria in Italy - are safe and effective.
“Internal assessments and the clinical data gathered during the 2012-2013 seasonal influenza studies required for European licensure of Agrippal and Fluad demonstrate a safety and immunogenicity profile similar to that of prior years.”
It added that: “Novartis is working diligently with local health authorities to address their questions. Novartis believes that it acted diligently and in good faith. As soon as the issue was identified internally, Novartis held the distribution of the batch in question, conducted further analysis and reported to the authorities.
The white particles found in the two products - which are described as ‘protein aggregates’ by several of the authorities involved - are common in vaccines according to Novartis.
Spokesman Eric Althoff told in-Pharmatechnologist.com that: "Protein aggregates are naturally occurring in vaccines in very small quantities and not uncommon. These aggregates are formed by proteins expected in the vaccine and can occur in the manufacturing process."
He added that: "Proteins are essential components of all influenza vaccines and a necessary part of production. The protein aggregates usually disappear with shaking – in fact the labels of influenza vaccines recommend to shake the product before use."
“It is also important to note, that the batch with a higher than normal level of protein aggregates was not released for distribution to the market. We are confident that no vaccine with high levels of aggregates in the final product was distributed.
“A review of other batches of Agrippal and Fluad showed that they were within specification, and therefore, released.”