Now UK Recalls Another Novartis Flu Vaccine – Agrippal – Recall Follows EU and Canadian Bans of Agriflu and Fluad Flu Vaccines

Following prior bans reported by CHS [EU And Canada Flu Vaccine Ban – Not Reported By Press] UK’s drug regulator the MHRA yesterday issued an announcement which includes the following:

At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of the above batches. This is due to the presence, in one of the components, of visible protein aggregates that were identified following additional testing during the course of an investigation. Such protein aggregation can occur in influenza vaccines. The aggregation consists mostly of viral proteins expected in the vaccine, and when observed, aggregation is transient and disappears upon shaking as recommended in product labelling. No visible protein aggregates were detected at the time of product release in any of these UK batches.

Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches. Those who have had a flu vaccine from these batches should have no cause for concern and there is no need for revaccination.

Class 2 Drug Alert (Action Within 48 hours): Novartis Vaccines and Diagnostics S.r.l. – Agrippal suspension for injection in pre-filled syringe – Influenza Vaccine – EL (12)A/34

Canada and Switzerland lift Novartis flu vaccine bans – Austria, France, Germany, Italy and Spain Yet to Decide

UPDATE TO CHS ARTICLE Posted October 30, 2012:  EU And Canada Flu Vaccine Ban – Not Reported By Press

Reuters reported at 16:09 GMT that Canada and Switzerland have lifted the ban on Novartis flu vaccines on the basis that “white particles found in the vaccines were normal clumps of protein particles and did not indicate a safety issue”  Canada, Switzerland lift ban on Novartis flu vaccines ZURICH | Wed Oct 31, 2012 4:09pm GMT.

But CHS notes that the news should be reported so that there is at least the possibility that the conduct of drug companies and drug regulators can be subjected to public and political scrutiny.  We cannot be sure they tell the truth – as we know some have not done on previous occasions.  They may also be wrong.  Are white particles in vaccines safe and normal “clumps of protein”.  If the news is not reported there is no prospect of anyone scrutinising what is taking place.