The ban on 500,000 doses of flu vaccines manufactured by Novartis extends so far to Canada, Austria, France, Germany, Italy, Spain and non EU state Switzerland but appears to have gone largely unreported in the mainstream media even though the news was put out on the wire by news bureau Reuters. The first ban appears to have been announced by the Italian Medicines Agency: Ban on the use of influenza vaccines in the Novartis Vaccines and Diagnostics 25/10/2012. The official Italian document can be downloaded here Comunicazione AIFA. You can search Google News yourself in your own country to check for any mainstream media reports.
The conduct of health officials and drug regulatory agencies should be subject to careful public scrutiny in the media. Health Canada’s statements are especially troubling.
The bans follow the news the previous week that Netherlands-based vaccine maker Crucell, a unit of U.S. drugmaker Johnson & Johnson, had suspended a delivery of 2.36 million seasonal flu vaccine doses to Italy after finding problems with two lots of it: Crucell temporarily withholds supplies of influenza vaccine NeLM 08/10/2012 Source: BBC Health , Daily Telegraph; UPDATE 3 -Italy bans Novartis flu vaccines pending tests Reuters–24-Oct-2012.
STOP PRESS 17:00 October 31: Reuters reported an hour ago 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 and 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.
The day after the European bans on the Novartis products, Health Canada stated the problem is common in vaccines, they have seen it before and claim to have had no reports of health problems. But they also fail to report making any effort of any kind to investigate. If this is “common in vaccines” Austria, France, Germany, Italy, Spain and Switzerland would not have banned the vaccines. It seems Health Canada had previously done nothing about it. This time they have been caught out by the European bans and appear to have banned the vaccines as a precaution: Novartis Suspends Distribution of Seasonal Flu Vaccines Agriflu and Fluad in Canada as a Precaution Health Canada News Release October 26, 2012:
OTTAWA – Health Canada would like to provide further information to Canadians about its assessment of the voluntary suspension of use in Europe of the seasonal flu vaccines Agriflu and Fluad.
…. Agriflu and Fluad are two of the seasonal flu vaccines produced by Novartis that have been pulled from use in several European countries pending further examination of white floating material discovered clumping in the vaccines.
Clumping of the kind noted in Europe is common in vaccines. Health Canada has previously seen such particles before in other vaccines and has observed no impact on their safety or effectiveness. The Public Health Agency of Canada monitors for adverse events following immunization. To date it has received no reports of serious or unexpected adverse events related to these vaccines.
As a precautionary step, Health Canada asked Novartis to suspend distribution of the vaccines in Canada until a full review of the situation is completed. Novartis has agreed. The Public Health Agency of Canada is also recommending that health care professionals in possession of these vaccines refrain from using them until the review is complete.
And Health Canada also claimed seemingly falsely that the European ban was voluntary by Novartis, but that is not correct – according to the Italian authorities they issued an official ban. That according to Reuters news reports [see links below] was followed by other EU states:
The Italian Medicines Agency has prohibited the use of influenza vaccines Fluad – AGRIPPAL – INFLUPOZZI subunit is INFLUPOZZI ADJUVANTED of Novartis Vaccines and Diagnostics Srl.
The measure was necessary because the Novartis Vaccines and Diagnostics Srl announced the presence of a phenomenon of protein aggregation observed in the production of influenza vaccines submitting reports qualitative assessment, toxicology and pharmacovigilance that do not provide sufficient information to clarify the exact composition of the aggregates, or the impact of the defect on the quality, stability of the vaccine and, consequently, on the safety and efficacy of the same. We are waiting for the further investigations and analyzes deemed necessary also the outcome of the evaluation of the documentation notes that the company will have to send.”
The Italian ban was followed by a series of news reports by Reuters Oct 25th and 26th:
- UPDATE 3 -Italy bans Novartis flu vaccines pending tests Reuters–24-Oct-2012
- Spain regulator halts sale of some Novartis flu vaccines Reuters UK – Oct 25, 2012
- UPDATE 5-Novartis defends flu vaccines after Italian ban Reuters UK – Oct 25, 2012
- Novartis does not expect further sales bans of flu vaccines Reuters–25-Oct-2012
- France halts sale of Novartis flu vaccine Reuters Paris Fri Oct 26, 2012
- UPDATE 1-France halts sale of Novartis flu vaccine Reuters Fri Oct 26, 2012
Associated Press eventually also reported the story 27th October: 6 European countries pull Novartis flu vaccines but also added that Novartis had known of the problem since July but had not reported it until now and only to the Italian medicines agency AIFA. AP also reported that by then Austria, France, Germany, Italy, Spain and Switzerland had limited the use of Fluad or Aggripal, or both, after the company reported the appearance of small particles in the vaccine to Italian authorities.
In the light of the recent problems the British Broadcasting Corporation and criticism the British media are facing over not reporting the activities of the television celebrity Sir Jimmy Savile as the most prolific child pervert and molester over a 40 year period, these kinds of failures seem to be common.
You can search Google News yourself in your own country to check for any mainstream news reports. The result of the first page of a search on Google India appearing below seems to indicate the news is not being reported internationally by mainstream news outlets.
In-PharmaTechnologist.com–45 minutes agoNovartis says two seasonal influenza vaccines temporarily banned by … the 2012-2013 seasonal influenza studies required for European …
Deutsche Welle–26-Oct-2012Several European countries have banned a flu vaccine produced by the Swiss pharmacetucial company, Novartis, for safety reasons. DW looks …
SmallCap Network–9 hours agoThe company’s influenza vaccines Agrippal and Fluad in most of the European market, and more recently, in parts of Canada; more bans are …
CTV News–27-Oct-2012A total of six European countries have banned the vaccine until further … of flu vaccine manufactured by drug giant Novartis –at a plant in Italy.
The Associated Press–26-Oct-2012BERLIN (AP) — Six European countries have ordered a temporary ban on the import or use of some Novartis flu vaccines. Austria, France …
Economic Times–24-Oct-2012Novartis does not expect further sales ban of flu vaccines … shipped the two vaccines produced in Italy to European markets and parts of Asia.
Reuters–26-Oct-2012(Adds comment from European Medicines Agency) … the announcement by Swiss and Italian authorities on Wednesday that they were banning some flu vaccines … Agrippal is the only Novartis flu vaccine marketed in France.
PMLiVE–28-Oct-2012… Austria and Italy in banning flu vaccines produced by Novartis after … which doesn’t extend to Fluad, is pending action from the European …
Reuters India–26-Oct-2012The French decision follows the announcement by Swiss and Italian authorities on Wednesday that they were banning some flu vaccines …
Reuters India–25-Oct-2012… European countries in halting the sale of anti-influenza vaccines made … anti-flu vaccines produced by Novartis was banned on Wednesday …
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