Italy banned the sale of Novartis ($NVS) influenza vaccines pending tests for possible side effects, and Switzerland took precautions too, Reuters reports. Initial reports show the ban followed discovery of white particles in the injections.
Agrippal, Fluad, subunit Influpozzi and adjuvanted Influpozzi all received red flags from the Italian Health Ministry. The ministry said 487,738 vaccine doses were affected. Switzerland's drug watchdog also marked Agrippal and Fluad as cause for concern.
"Given the current unclear situation Swissmedic has issued a halt to deliveries for the cited vaccines and recommends not using them until further notice," the watchdog said.
Novartis said the products are safe, Bloomberg reports, but the company did not provide enough information for officials to know the exact makeup of the proteins found in the flu shots and how that might affect their safety. Novartis alerted Italian officials of the vaccine issues Oct. 18, following up with a written notification the next day. Officials say the company knew of the particle buildup since July 11.
Novartis gave Italian authorities "an assessment which supports the quality, efficacy and safety of the vaccines," Eric Althoff, a Novartis spokesman, told Bloomberg in an email. "The company will continue to work with the Italian minister of health and AIFA to understand the reason for their decision."
- here's more from Bloomberg
- see the Reuters article
- check out FiercePharma's take