December 1, 2014
By Mark Terry, BioSpace.com Breaking News Staff
The Italian Pharmaceutical Agency (AIFA), the country’s drug regulatory agency, announced Sunday that it was investigation 13 deaths potentially related to a flu vaccine manufactured by Novartis . Two lots of the company’s seasonal flu vaccine, Fluad, have been recalled following three deaths and one person suffering severe adverse effects.
The lots are 142701 and 143301. Novartis has released a statement to Biopharma-Reporter.com saying that “no causal relationship to the vaccine has been established.”
Novartis’s Fluad vaccine won approval in 1997 and has provided over 65 million doses since worldwide. There was a temporary ban by AIFA in 2012 when a batch was found to contain protein particles.
“Patient safety is our first priority and we take these reports very seriously,” the company wrote to Biopharma-Reporter.com. “A review of the two batches has confirmed that they are in conformity with all production and quality standards. Novartis is working closely with AIFA for further assessment.”
The three recent deaths occurred within 48 hours of receiving Fluad. Other cases occurred in Sicily, Puglia, Tuscany, Emilia Romagna, Lombardy, Molise and Lazio. The most recent death was of an 83-year-old from Umbria. The two lots under investigation were both produced at a Novartis manufacturing facility in Siena, Tuscany.
A detailed investigation by the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency will begin today and is expected to have a report by Thursday.
In November, Basil, Switzerland-based Novartis inked a deal to sell its flu vaccine division to CSL Limited for $275 million. That would include manufacturing sites in Holly Springs, N.C., Liverpool, U.K., and Marburg, Germany. The agreement is expected to wrap up in mid-2015.
This deal would create the second-largest vaccine company in the industry. CSL also has facilities in Melbourne, Australia.
“The acquisition will more than triple our capacity with the addition of first-class manufacturing facilities, increase the global footprint of bioCSL to more than 40 countries, and provides us with a diversified portfolio of influenza products covering all ages,” said Natalie DeVane, CSL spokeswoman in a statement. “We expect the deal to be accretive in 2-3 years with annual sales approach $1bn over the next three to five years.”
Fluad is created by growing influenza virus strains in embryonated hens’ eggs. They are harvested, centrifuged and filtered, then inactivated with formaldehyde. After concentration and purification, most of the internal proteins are removed. Novartis utilizes MF59, an immunologic adjuvant to increase the antibody response.
