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One for Italy.... phew, ban on Novartis flu vaccines !!!!

 
pray_Italy
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Italy
10/24/2012 11:34 AM
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One for Italy.... phew, ban on Novartis flu vaccines !!!!
After the ridiculous ruling on the EQ a few days ago (which hopefully will be overthrown in appeal), FINALLY some good news:

This is the Google-Translation of the article:

Stop in flu vaccines Novartis
"Necessary checks on safety"


An immediate ban on the purchase and use "until further notice" was prepared by the Ministry of Health in agreement with the AIFA. Four products influenza which have been urged further tests especially with regard to the possible side effects. This block comes just a few days away from that imposed on drugs Crucell

ROME - New stop the anti-flu prevention campaign. A few days away from the block of 2 million 350 thousand doses of vaccine and pharmaceutical company Crucell 2 , comes a new stop by the Ministry of Health and the AIFA, the Italian agency for the drug.

This time an immediate ban on the purchase and use has been imposed on four types of influenza vaccine produced by Novartis. The vaccines are implicated AGRIPPAL, Influpozzi subunit, Influpozzi adjuvanted and Fluad. From that stated by the Minister Balduzzi "the measure is a precautionary measure and pending further investigation."

"Citizens are asked not to buy or use such vaccines until further notice in this regard," said the ministry in a statement. The AIFA, based on the documentation submitted by the company, has established the need for further investigation "about the quality and safety of themselves, since these may have an increased reactogenicity, the ability to induce side effects and adverse reactions ". At the moment there would be circulating in the country 490 000 doses of these vaccines. The Minister of Health is closely following the situation.

Meanwhile, it is already gone notice to all pharmacies in Italy. Annarosa Raccalo, the president of Federfarma confirmed that shortly after the announcement by the ministry "were contacted immediately over 18,000 Italian pharmacies."

But the prohibition on the purchase and use of influenza vaccines from Novartis will create many problems to the Italians and the National Health Service. "We will remain uncovered for a while ', now that it started the vaccination campaign - says Professor Walter Ricciardi, director of the Institute of Hygiene of the Catholic University of the Sacred Heart in Rome and President of the Third Chamber of the Supreme Council of Health. "In Italy we vaccinate every year especially all over 65, there are at least ten million people who need the vaccine - added - there is no doubt that it will create a huge problem."

A problem at the moment, as many local health services, is also facing the healthcare company in Milan. "Cautiously - says Ciconali, Director of Hygiene and Public Health Service ASL Milan - we subdivided the orders of the vaccine in three parts: 65 000 doses of Crucell, Novartis and other 75 000 from 75 000 to Sanofi," for a total of more than 200 000 doses. "There could hardly expect problems in two out of three companies, but it happened."

"It 's really terrible," says the expert. "After the communication of Crucell last week, now the Region of Lombardy had reassured us that were set on all the procedures for the recovery of missing doses, but now the crisis is certainly worse and right now there is the possibility of compromised satisfy all segments "of the population 'target' of vaccination. "Not to mention that - adds the expert - vaccines banned today are the ones that we should be delivered to general practitioners, specifically designed for the elderly and frail patients. Obviously I am confident that we can find a solution quickly, but at the moment are quite capable of making predictions. remains to be seen. As they say, there is no limit for the worst. "

Meanwhile, the Codacons is very concerned about this new stop. "The Minister Balduzzi - explains the consumer association - must make it clear whether or not there are risks to the health of users, and if you now record delays in the supply of vaccines in our country." Codacons asked in particular to be able to "understand what is happening, and how it is possible that many vaccines are withdrawn from or banned after the analogous case of the products of Crucell." "The Italian and European health authorities - continued Codacons - must open an investigation to clarify and correct information to citizens." On the question of the association has already denounced in recent months as in Italy, although the law requires only four pediatric vaccines required, it should be administered at 6, a choice illogical and harmful to the community which costs 114 million euro per year.

The situation by region. The first block of the vaccines come from the Veneto. All doses present in Ullss, about 170,000, were apprehended. "No amount, came to the end user. Then there is nothing to fear, among other things, the start of the vaccination campaign is planned public from 5 November," said the Regional Minister of Health of the Veneto Luca Coletto

In Tuscany has never been distributed. The nearly 400,000 doses ordered by the local health authorities are still not even, as reported by the commissioner, Tuscan Right to Health Louis Brown.

In Trentino Alto Adige have ordered vaccines from Novartis and after the block of Crucell vaccines are still waiting to find another pharmaceutical company that can provide the vaccine.

In Liguria totaled 139mila and 300 doses of flu vaccine that the pharmaceutical company Novartis had won the regional competition, as in Tuscany but have not yet arrived.


Source: [link to www.repubblica.it]
Treyfish

User ID: 14756837
United States
10/24/2012 01:07 PM
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Re: One for Italy.... phew, ban on Novartis flu vaccines !!!!
Urgent: Citizens Urged to not Purchase and to not Use Novartis Influenza Vaccines

Press Release n. 216 – October 24 2012



The Ministry of Health and Italian Agency for Drugs Safety (AIFA) ordered the immediate precautionary interdiction to use the following seasonal influenza vaccines, until further investigations will be done:
Agrippal;
Influpozzi sub-unit;
Influpozzi adjuvanted;
Fluad.
Concerned citizens are urged to not purchase and to not use the above vaccines until a new pronouncement by the Ministry of Health.

The interdicted vaccines have been made by Novartis company.

The AIFA, on the basis of the documentation presented by the company, ordered additional investigations on the quality and safety of such vaccines, because of the possible increased reactogenicity of them, or their ability to cause adverse reactions and side effects.

The Minister of Health, professor Renato Balduzzi, is closely following the situation. Further details will be available later this day.
- [link to www.salastampa.salute.gov.it]
Treyfish

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United States
10/24/2012 01:30 PM
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Re: One for Italy.... phew, ban on Novartis flu vaccines !!!!
Italy Bans Novartis Flu Vaccines, Citing Side Effects

Italy’s Health Ministry asked consumers not to use Novartis AG (NOVN)’s flu shots until further notice because of “potentially dangerous” side effects.

Novartis informed the government of a buildup of proteins in the Agrippal and Fluad vaccines, the ministry said in an e- mailed statement today. The company didn’t provide enough information “to clarify the exact composition of the buildup, nor the impact of the defect on quality, on the stability of the vaccine, and the consequence on security and the efficacy” of the shots, according to the statement.

The vaccines present “quality defects that are potentially dangerous for public healt..
[link to www.businessweek.com]
pray_Italy  (OP)

User ID: 26232549
Italy
10/24/2012 04:48 PM
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Re: One for Italy.... phew, ban on Novartis flu vaccines !!!!
banana2
pray_Italy  (OP)

User ID: 26232549
Italy
10/24/2012 05:11 PM
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Re: One for Italy.... phew, ban on Novartis flu vaccines !!!!
SWITZERLAND takes immediate action and stop delivery of Novartis vaccine !!!!!!!!!


Swissmedic stops delivery of flu vaccine from Novartis dangerous

In response to the investigation by the Italian authorities, Swissmedic has ordered on Wednesday for an immediate stop to the delivery of flu vaccines from Novartis, as the Therapeutic Products announced.

The Ministry of Health in Italy has the use of three flu vaccines from Novartis temporarily banned because of possible side effects. First, new research results to be waited for, it said in a statement.

Then the Swiss Agency for Therapeutic Products has Swissmedic responded and stopped the export of vaccines.

It was clarified immediately, whether vaccines could be affected, which are available in Switzerland. Initial investigations have revealed that the blocking was in Italy, because in the syringes white particles were observed. It might be due to clumping of normal components of the vaccine.
Precaution

According to the statement adopted the Italian Ministry of Health and the local remedies Authority (AIFA), the prohibition in the sense of precaution. The use of the three vaccines Agripal, Fluad Influpozzi and is therefore prohibited from immediately.

On the basis of documents of the Basel pharmaceutical company Novartis had submitted the AIFA decided that first new checks on the safety and quality of these vaccines are necessary. This may cause side effects and adverse reactions.

The population has been asked not to buy the affected vaccines and also not to use.



Source: [link to www.blick.ch]
Anonymous Coward
User ID: 13574707
United Kingdom
12/01/2014 08:19 AM
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Re: One for Italy.... phew, ban on Novartis flu vaccines !!!!
bump for relevance





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