Despite deaths, Italian regulators declare Novartis flu vaccine safe—for now
- In the last two months, 19 elderly Italian people (aged 65 and older) who received the Novartis flu vaccine Fluad have died.
- After extensive safety testing, the Agenxia Italina del Farmaco (AIFA) has concluded that the vaccine is safe, the Wall Street Journal reports.
- AIFA had suspended use of Fluad as a precaution as testing was conducted over the weekend.
In Italy, 8,000 people per year die of complications from the flu. Most people who die from the flu are elderly, i.e., aged 65 and above.
Vaccination is a standard cautionary measure to prevent flu-related death in various populations, including the elderly. However, as Novartis has pointed out, many elderly people have underlying medical conditions that increase their risk of death even under normal circumstances. Moreover, among the 19 Italians who have died during this period, most were over the age of 80—a population that has an even higher risk of death.
The AIFA will continue testing Fluad, and the European Medicines Agency will conduct another review of the drug. Stay tuned.