Flu vaccine underwent 35 QA/QC tests in Italy death probe, says Novartis

05-Dec-2014 - Last updated on 05-Dec-2014 at 12:09 GMT

Novartis' Fluad was under investigation relating to 19 deaths in Italy earlier this week

Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.

It has been a turbulent seven days for Novartis' vaccines business.

Last Friday the Italian Medicines Agency (AIFA) suspended two batches of its seasonal flu vaccine Fluad after reports that 19 people had died shortly after getting the shot.

Investigation found no causal relationship according to Susan Stuart from Novartis Vaccines and Diagnostics who told Biopharma-Reporter company policy is to examine all such incidents in collaboration with regulators.

“Every time a serious adverse event is reported to Novartis, a team of medical and quality experts conduct rigorous investigation,” she said. “All Fluad batches have passed extensive analytical and safety testing and fulfill all required quality standards.”

Novartis continues to work with AIFA on the matter, but Stuart added Fluad is indicated for and administered to elderly patients often with underlying cardiovascular and other chronic disease.

“Due to the high level of natural deaths in the target population and the high number of vaccines distributed, timely association between natural deaths and vaccinations do occur.”

Manufacturing QA/QC

Fluad is manufactured from components produced at Novartis’ facilities in Bellaria-Rosia and Siena, Italy, as well as sites in Liverpool, UK, and Marburg, Germany.

“The sites are involved in making different parts of the vaccine however it’s final ‘fill and finish’ and packaging etc. takes place in Italy,” we were told. “These sites have been involved in the internal assessment of Fluad, to provide all the needed documentation to AIFA.”

Head of vaccine research Rino Rappuoli gave more details on how Novartis ensures the quality of its vaccines:

“The quality control of vaccines begins upstream, with the analysis of raw materials, and tests are conducted along all the production processes,” he said in an interview with the Italian news agency ANSA. “Then each of the individual components of the vaccine, that in the case of Fluad are four, undergoes 19 tests, from sterility to purity, while the end product is subjected to 14 others.

“It’s impossible that something contaminated can emerge; within the company we have 500 people who deal exclusively with this. On top of these tests then come those conducted by the Institute of Health (ISS) before releasing the batch.”

Vaccine Exit

Novartis is likely to exit the vaccines business within the next year, with the US Federal trade Commission (FTC) recently approving the $7bn acquisition by GlaxoSmithKline of the division (excluding flu vaccines) which was first announced in April.

The vaccine manufacturing sites in Siena and Bellaria-Rosia form part of the deal with GSK, Stuart confirmed, while Novartis’ sites in Marburg and Liverpool form part of the $265m sale of its influenza business to CSL Limited, announced in October.

“The decision to divest Vaccines and separately the Influenza business was part of Novartis’ portfolio review that began in mid-2013,” Stuart told us. “As part of this, Novartis explored opportunities for smaller business units, as it is important that each of its businesses have global scale and are leaders in their categories.”