Regulatory authorities in Switzerland and Italy said that Novartis had not provided enough data for officials to be able to decide exactly what the proteins found the flu shots were, and what effect, if any, they might have on quality and safety.
Health authorities in both countries emphasized that they have received no reports of illness caused by the particles.
An announcement made by Italy's Ministry of Health, informed that "quality defects that are potentially dangerous for public health."
AIFA (Agenzia Italiana del Farmaco), italy's medicines agency said that it "has established the need for further tests regarding the vaccines' quality and security."
Novartis, along with Johnson & Johnson, have had a bad time of manufacturing woes recently. Novarty had to temporarily close its plant in Lincoln, Nebraska, because of quality concerns; there the company manufactures Excedrin, Lamisil and Sentinel.
Apart from insisting that the vaccines are completely safe, Novartis says it has given Italian authorities an assessment which supports the efficacy, safety and quality of the products. Novartis added that it is liaising closely with Italian ministry officials and the Minister of Health, as well as AIFA to understand the reasons for their decision and to clarify any question.
The Italian Health Ministry said that approximately 488,000 doses have been banned.
The Swiss regulatory drug agency, Swissmedic, banned the distribution of the shots as a precautionary measure, after the Italian ban. Swissmedic assured patients who have already had the shot that there are no dangers.
Swissmedica added that the particles found in the syringes could simply be clumps of normal components of the vaccine.
Five percent of Novartis' income is from vaccines.
In an online communiqué, Novartis wrote:
"The protein aggregates observed in the one batch that led to precautionary measures in some markets can occur in the normal vaccine manufacturing process and have no impact on the safety or efficacy of the vaccines."
Agrippal and Fluad are not sold in the USA. In Germany they are marketed under the trade name Begripal. In Italy they are also known under the trade names Influpozzi sub unità and Influpozzi adiuvato.
Both Italian and Swiss health ministries emphasized that there is no flu vaccine shortage.
Written by Christian Nordqvist