EU nations ban Novartis influenza vaccine after dangerous proteins found

EU nations ban Novartis influenza vaccine after dangerous proteins found

A handful of European Union (EU) member nations have banned several influenza vaccines manufactured by Swiss drug maker Novartis after agglomerations of small, white proteins were discovered floating in batch injections of the flu jabs Agrippal and Fluad, neither of which are sold in the U.S. According to the drug giant, both vaccines are allegedly still safe, but Germany, Spain, Switzerland, Austria, Italy, and France are not taking any chances, having all recently decided to block sales of the affected vaccines until more is known about the issue.

The tainted vaccines were first discovered in Italy, which prompted immediate action by the Italian government to ban not only Agrippal and Fluad, but also Influpozzi and adjuvanted Influpozzi. Following Italy's decision, both Germany and Spain implemented their own bans, which prompted subsequent bans by Switzerland, France, and others. These decisions came as the European Medicines Agency (EMA), which evaluates the safety of drugs and vaccines approved centrally for use throughout the EU, announced that it would not lead an investigation into the safety of the vaccines, as they were all approved nationally rather than centrally.

Novartis has also released little information thus far about what the floating particles are, and how they might affect vaccine safety. The company, which has seen an increasing share of safety problems in recent years, offered duplicitous explanations concerning both issues, assuring the public that, even though it is unclear as to the contents of the particles, the affected vaccines are still somehow safe for public use.

Authorities in France, Italy, and elsewhere have also been repeating some of the same empty reassurances, despite their imposed bans. French Health Minister Marisol Touraine, for instance, made a public announcement claiming that none of the impurities had yet been found in vaccines distributed throughout France, and that there "is no known risk" for patients who have already received injections of the now-banned vaccines. The Swiss regulatory drug agency issued similar reassurances, adding that the white clumps are probably just "normal components of the vaccine."

"Given the current unclear situation, Swissmedic has issued a halt to deliveries for the cited vaccines and recommends not using them until further notice," added the agency.

Netherlands-based vaccine maker Crucell, which is owned by U.S. drug maker Johnson & Johnson (J&J), also reportedly halted an Italian shipment of 2.36 million doses of a different seasonal flu vaccine, Inflexal V, after two lots out of 32 failed quality control inspections. Crucell says it is holding deliveries of all its seasonal flu vaccines pending an internal investigation.

Sources for this article include:

http://www.reuters.com

http://www.pmlive.com

http://www.medicalnewstoday.com/articles/252120.php

http://www.fiercepharma.com