Moscow, November 29 (Sputnik) — The Italian Pharmaceutical Agency (AIFA) has banned two batches of an influenza vaccine by Swiss pharmaceuticals giant Novartis following three deaths and a fourth person listed in critical condition, TheLocal.it reported.
The victims, two women aged 79 and 87, along with a 68-year-old man, died earlier this month in the south of the country, with a fourth, a 92-year-old man, in hospital in serious condition. The deaths occurred within 48 hours of administration of the vaccine. The suspected batches were produced at a Novartis plant in Siena, about 240 km north of Rome.
The AIFA banned the sale of the medicine in drug stores on Friday following an investigation which began after the first deaths in mid-November, and urged people to check the batch numbers and to contact their doctors if they match those which have been recalled.
A statement by Novartis denied any wrong-doing, noting that an internal review of the two batches of the vaccine “has confirmed that they are in conformity with all production and quality standards,” and that so far, “no causal relationship [of the deaths] to the vaccine has been established.” The company also added that it has a “robust” safety record, the influenza vaccine in question, Fluad, having been in use since 1997, with over 65 million doses having been administered, the BBC explained.
AIFA similarly noted that “the relationship between administration of the vaccine and the deaths is not certain” due to the number of causal deaths being “too low”, but made the decision to withdraw the drugs as a precautionary measure. The two batches total 460,000 doses, out of a total of four million produced for the Italian market, Corriere Della Sera has explained.
Italian consumer protection association CODACONS had called on the country’s health minister to suspend pro-vaccination campaigns altogether, but the AIFA insisted that vaccines were “a precious resource and irreplaceable for the prevention of seasonal flu." AIFA head Sergio Pecorelli noted that 8,000 people die of the seasonal flu each year, saying that his agency aims at making sure “that the number of people who get vaccinated does not drop,” TheLocal.it quoted him as saying.
The Italian Ministry of Health and the AIFA had earlier withdrawn four Novartis-made medications in late 2012, Fluad among them, the medicines then suspected of causing increased side effects. The batches in question were later readmitted when safety checks had ruled out defects, Corriere Della Sera noted.