December 2, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Only two days after the Italian Pharmaceutical Agency (AIFA) announced it was investigating Novartis ’ flu vaccine, Fluad, in up to 13 deaths, the regulatory agency announced the vaccine was safe.
“The results of the tests confirm the safety of the anti-flu vaccine,” AIFA said in a joint statement with the Italian health ministry, “exclude the presence of endotoxins, and show the batches conform to the appearance and content of the vaccine antigen of the influenza virus.”
The Italian agency was investigating two lots of the vaccine, 142701 and 143301, after three deaths and one case of severe adverse effects shortly after receiving the vaccine. In light of publicity, about 13 more cases came to light, although now the agency is indicating those cases are not related.
Fluad was approved in 1997 and has been administered more than 65 million times. In a statement, Basel, Switzerland-based Novartis said, “No unusual frequency of adverse events has been reported through the extensive pharmacovigilance system.”
In related news, the Public Prosecutor’s Office in Turin, Italy has been investigating another flu vaccine manufactured by Novartis, Agrippal. There is no indication yet whether the investigation will continue pending this latest dismissal.
In late 2012 Italy banned some of Novartis’s flu vaccines, including Fluad, after protein particles were observed in some of the lots. After a brief investigation, the particles were found to be particles of egg white, an ingredient in the vaccine.
At least one source, according to the Wall Street Journal, indicates that AIFA will continue testing Fluad, noting that the reversal was based on an initial analysis. Novartis issued a statement over the weekend citing that “no causal relationship to the vaccine has been established to date.” The two suspected batches, making up 500,000 doses, had only been distributed in Italy. Novartis went on to say that Fluad is “often prescribed to patients who suffer from pre-existing, underlying medical conditions and have a weaker immune system. Serious medical events and deaths are, unfortunately, quite common in this patient population.”
Of the deaths reported in November, most were more than 80 years old. Pointing out that about 8,000 people die each year of the flu in Italy, AIFA and the Italian health ministry have urged people to continue to receive flu vaccines. “On the basis of these findings, [the agencies] invite all subjects, especially those at risk [of contracting the flu], to undergo the vaccination in order to avoid the complications of this infectious disease.”
