Re: Italy: AIFA imposes the ban for two batches of the influenza vaccine FLUAD - 11 suspected deaths
Re: Italy: AIFA imposes the ban for two batches of the influenza vaccine FLUAD - 11 suspected deaths
AIFA: twelve cases suspected
THE AIFA shall inform that after the ban on the use of lots 143301 and 142701 of the vaccine FLUAD following the reporting of three deaths that have occurred between 7 and 18 November, Yesterday were inserted other 8 reports (deaths that have occurred between 15 and 28 November) of which the Agency has asked for a detailed clinical report that so far has not yet been received for any of them. In today's day and have been recorded in National Network of pharmacovigilance (RNF) a new death occurring on 24 November and yesterday and received an e-mail on a death that has yet to be verificata.il total cases reported through the RNF is therefore 12.
A first analysis of these signals allows you to draw the following conclusions exclusively preliminary:
In 8 cases (67 %) of people aged ≥ 80 anni.7 cases are female and 5 male. In 8 cases the death occurred in the first 24 hours. In 8 cases the death occurred for cardiovascular causes. The reports concern 6 Regions: Sicily (2); Molise (1); Puglia (2); Tuscany (2); Emilia Romagna (2); Lombardia (2); Lazio (1) .The batches involved are passed from 2 to 6 for a total of 1,357,399 doses. The reports are received by the RNF with a time range from immediate (same day of the death) in 13 days dopo.se all doses of these 6 lots were administered, The percentage of deaths would increase from 0,001 % (1.2 every 100.00 ) to 0.0009 % (0.9 every 100.00 ) with a dilution of 25% of the segnale.se nor were administered only half the number of deaths would be at least less than hundreds of times than expected in the same population not vaccinated (about 8,000 to the Year deaths due to complications of the flu).
THE AIFA confirms the temporal correlation suspected for cardiovascular events in the first 24 hours of the administration in patients over eighty years suffering from polipatologie and politrattamento. The Fluad and however expressly indicated in this population. The therapeutic indications of the technical details of this vaccine are in fact active immunisation against influenza in the elderly (aged 65 and over), especially in subjects with a greater risk of complications associated with (for example subjects with chronic diseases such as diabetes, Cardiovascular disorders and respiratory) .It is important then contextualize the expected number of deaths in this population in relation to doses actually administered.
It is therefore important contextualization of the expected number of deaths in this population in relation to doses actually administered. The Italian population over 65 is equal to 12.5 million people; of these approximately 500,000 unfortunately die every year, which equates to 1,369 deaths per day among people over 65. Even assuming that only 10% of these are vaccinated with Fluad ( 50,000 people over 65, estimate unlikely because it is likely that in this age range are many more), We would have 136 people died in this population per day (the causes of which should be for the 65% cardiovascular; 13% breathing; 6% stomach; 5% central nervous system and the remaining 11% for other reasons).
Even if only 10% of the adverse reactions were reported (and the AIFA has no reason to believe that our RNF is so deficient), there would be 13 deaths per day, rather than 12 in 22 days, which corresponds to 4% of the minimum expected. The doses are currently deployed with Fluad in our country are equal to 3.5 million and, Even assuming conservatively that neither have been used only 1 million,
the numbers seem to confirm that should not be a problem in the production process or contamination of the vaccine - which i remember - and subjected, in accordance with international procedures for authorization, To 38 controls 14 of which on the finished product, and 23 on the individual components before each batch is released on the market. The company must provide within next Monday at 13:00 an update report on all quality controls repeated batches seized and a clinical evaluation of the possible cause and effect. In the course of the next week will see the first results of the analyzes of the Superior Institute of Health, even if the calculation on mortality suggests that there are no variations out of range in the quality of the vaccine. THE AIFA has prompted a discussion of the case to the European Committee for the pharmacovigilance (PRAC) of the European Medicines Agency (EMA), which will begin next Monday and will conclude thursday, December 4. While the surveys are going forward, the AIFA reaffirms the importance of influenza vaccination, as the influence is not a "ailment of the season" but a infectious disease serious which can have serious complications, especially for individuals at risk. Every year there are in fact approximately 8,000 deaths from cardiovascular complications related to influenza,
http://www.agenziafarmaco.gov.it/it/content/vaccino-fluad-laifa-fa-il-punto-della-situazione-0
