Novartis flu vaccine cleared following safety probe
pharmafile | December 3, 2014 | News story | Sales and Marketing | GSK, Novartis, Vaccine, flu, fluad
The Italian drugs safety agency has cleared the Novartis influenza vaccine Fluad, after an investigation found the vaccine was not linked to deaths in the country.
Last month reports emerged that 19 people in Italy who had the Fluad vaccine had died, in some cases several hours after being vaccinated. Most people were over the age of 80, making it difficult to establish a causal link between the vaccine and the deaths.
The Italian institute of health had suspended two batches of Fluad as a precautionary measure. But after an analysis of vaccine samples this week, the Italian Pharmaceutical Agency says all tests are ‘completely negative’ and confirmed the safety of the drug.
A statement from the agency says: “Test results confirm the safety of the flu vaccine, exclude the presence of endotoxins and showed that the lots conform to the appearance and content of the vaccine antigen of influenza virus.
“On the basis of these findings, [we] invite all subjects, especially those at risk, to undergo the vaccination in order to avoid the complications of this infectious disease.”
The agency says the increase is likely to be “attributable to the greater sensitivity shown by health professionals and the general population to the phenomenon” after recent reports in the media.
In a statement Novartis vouched for the safety of its product, saying: “Fluad is approved for vaccination in the elderly over the age of 65 years and in those with disease risk. Severe clinical and deaths are unfortunately quite common in this patient population and, therefore, a temporal association with vaccination is not unusual.
“Each year about 8,000 deaths in Italy are attributable to seasonal influenza (40,000 in Europe). Novartis is continuing to collaborate with the health authorities and regulatory standards for all further tests that will be needed.”
The Fluad vaccine was approved in 1997 and more than seven million doses have been distributed this year and 65 million doses have been distributed to date globally, and all outside the UK. Novartis is in the process of selling its vaccine business to GSK for $7.1 billion.
Lilian Anekwe
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