German authorities have ordered a recall of some batches of Novartis‘ flu vaccine after the company reported finding small particles in the manufacturing process.
The Paul Ehrlich Institute, part of Germany’s Ministry of Health, stated that there have not been any reports of particle formation in Germany, or of any serious side effects of the vaccine during this year’s flu season, reports Boston.com. Institute President Professor Klaus Cichutek, stated:
“However, in the interest of risk prevention and consumer safety it is necessary to cancel the approval for certain vaccines, since the formation of particles in the vaccine and therefore the risk of serious side effects cannot be ruled out.”
The decision by Germany affects four batches of the flu vaccine Begripal and one batch of Fluad, but will not affect the season vaccine Optaflu.
Along with Germany, Italy and Switzerland have also banned some Novartis flu shots. Italy banned the sale of the drugs on Wednesday, including Fluad and Begripal, along with two others. Switzerland suspended deliveries of the drugs by Novartis as a preventative measure.
Bloomberg BusinessWeek notes that Britain’s Medicines and Healthcare products Regulatory Agency has not pulled the vaccines yet, but added that they are gathering more information about the Novartis vaccines.
Novartis, a Swiss pharmaceutical company, stated that they are cooperating with Italy’s Ministry of Health. They released a statement saying:
“Novartis confirms that these particles can occur in the vaccine manufacturing process and is confident that there is no impact on the safety of efficacy of the vaccine.”
There have been no adverse effects to date regarding the recalled vaccines.