Sunday, November 30, 2014

Italy: AIFA Investigating Deaths Among Flu Vaccine Recipients



# 9389


Flu vaccines have a long and enviable history of safety, and while side effects have been reported, serious reactions are very rare.  But no vaccine, or any other drug or medicine for that matter, is 100% safe or benign. 


Complicating matters, drugs and vaccines are often used by the elderly or those with pre-existing medical problems, making it difficult to sort out the cause whenever an untoward medical event occurs. 


This weekend, in Italy, officials are trying to determine if two specific lots of Novartis flu vaccine played any role in the recent deaths of a number of (mostly) elderly vaccine recipients.  Right now, there is no proof that the vaccines are at fault, but the use of two lots of the vaccine has been temporarily suspended.  


First, a status report from the Italian Pharmaceutical Agency (AIFA), followed by statements by Novartis, and by the European Medicines Agency.


Fluad vaccine. The AIFA takes stock of the situation

Twelve reports of deaths after vaccination received to date. 8000 people die each year from the consequences of influenza


The AIFA informs that after the ban on the use of lots 143 301 and 142 701 vaccine Fluad after reporting three deaths occurred between 7 and 18 November, yesterday were included eight other reports (deaths occurring between 15 and 28 November ) of which the Agency has requested a detailed clinical report that so far has not yet been received for any of them.

In the day today has been registered in the National Network of
Pharmacovigilance (RNF) a new death occurred on November 24, and yesterday received a 'e-mails on a death that has yet to be verified. The total number of cases reported through the RNF is therefore 12. A first analysis of these signals allows to draw the following conclusions exclusively preliminary:

  • In 8 cases (67%) seen in people aged ≥ 80 years.
  • 7 cases are female and 5 male gender.
  • In eight cases death occurred in the first 24 hours.
  • In eight cases death occurred from cardiovascular causes.
  • The reports concern 6 Regions: Sicily (2); Molise (1); Puglia (2); Tuscany (2); Emilia Romagna (2); Lombardy (2); Lazio (1).
  • The lots involved have passed from 2 to 6 for a total of 1,357,399 doses.
  • The signals are received by the RNF with a time range from immediate (same day of death) to 13 days later.
  • If all of the doses of these 6 lots had been administered, the percentage of deaths would rise from 0,001% (1.2 each 100.00) at 0.0009% (0.9 each 100.00) with a dilution of 25% of the signal.
  • If it had been given even half the number of deaths would be hundreds of times less than expected in the same non-vaccinated population (about 8,000 deaths per year for flu complications).

The AIFA confirms the correlation time for suspected cardiovascular events in the first 24 hours after administration in patients suffering from over eighty polypathology and polypharmacy. The Fluad however expressly indicated in this population

(Continue . . .)


This from Novartis:


Safety and efficacy of Fluad vaccinations in Italy

November 28, 2014 18:00 CET

Regarding the precautionary suspension of two batches of Fluad® in Italy, Novartis underlines that no causal relationship to the vaccine has been established to date.

Fluad is approved for vaccination of elderly patients (65+) and often prescribed to patients who suffer from pre-existing underlying medical conditions and have a weaker immune system. Serious medical events and deaths are unfortunately quite common in this patient population and hence a coincidental timely association with vaccination is not unusual.

The two suspended batches comprising of 500,000 doses were distributed solely in Italy after having passed all required safety and quality testing, including review by regulatory authorities before release to market.

Worldwide, more than 7 million doses of Fluad have been distributed. No unusual frequency of adverse events has been reported through the extensive pharmacovigilance system.

Fluad is an important vaccine to protect the elderly from influenza. They are at high risk of serious complications from influenza infections. In Europe alone, the death toll is estimated at 40,000 each year. Fluad was licensed in 1997 and has a solid safety history. The vaccine has been tested in clinical trials with 70,000 patients and more than 65 million doses have been distributed to date.


And this from the EMA.


Investigation into reports of serious adverse events following use of Fluad

EU regulatory authorities following up on suspension of two batches of flu vaccine in Italy

The European Medicines Agency (EMA) is working with the Italian medicines agency (AIFA) and other EU medicines regulatory authorities to investigate the cause of serious adverse events, including deaths, in a small number of elderly patients who had received Fluad flu vaccine. There is so far no evidence to suggest a causal link between the vaccine and the reported adverse events. The suspension is a precautionary measure.

AIFA has suspended the use of two batches of the flu vaccine produced by Novartis. Testing of the batches is underway, as well as a detailed analysis of the case reports from Italy. This includes examining all available information on the affected patients’ age, health condition and medication regime.

The issue will be discussed by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), a scientific body that brings together Europe’s best experts on the safety of medicines, at their meeting starting on Monday, 1 December 2014.

Member States across the European Union continue with their annual flu vaccination campaigns as influenza can cause severe illness or death especially in the elderly and in people with long-term conditions. The World Health Organisation (WHO) estimates that annual influenza epidemics result in about 3 to 5 million cases of severe illness worldwide, and about 250,000 to 500,000 deaths. Influenza vaccines are the most effective way to prevent the disease and/or the serious complications it can cause.

Fluad is authorised in the EU in a number of EU Member States. For the current vaccination campaign, 4 million doses of Fluad have been distributed in Italy. In the EU, the vaccine has also been distributed for the 2014-15 flu vaccination campaign in Austria, Germany and Spain.

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