The Swiss drug watchdog, Swissmedic, has lifted its one-week suspension of deliveries of Novartis flu vaccines after verifying that specific batches manufactured in Italy are safe.This content was published on October 31, 2012 - 16:56
A precautionary halt to deliveries was imposed on October 24 after the discovery of “possible impurities” at an Italian site where the vaccines were manufactured.
Swissmedic said in its original statement that at most 160,000 vaccine doses had been affected, adding that it had acted immediately being informed by the Italians.
The watchdog accepted evidence from Novartis demonstrating that white particles visible in the vaccines were not external impurities but some of the components of the vaccine which had clumped together.
Novartis confirmed that these particles can occur in the vaccine manufacturing process and that there is no impact on the safety or efficacy of the vaccine.
"Based on the available scientific evidence, the security and efficacy of the vaccine are in no way diminished by these particles present in certain syringes," Swissmedic said, adding that tests carried out in its laboratories confirmed the quality of the vaccines.
Italy uses between ten million and 12 million doses of flu vaccines every year, while Switzerland needs 1.3 million for its annual vaccination campaign.
Last week the Federal Health Office called on vaccine makers to speed up imports and deliveries of vaccine doses as medical practices and hospitals could be facing a shortfall.
The health office has asked medical professionals to focus on vaccinating risk groups in the coming weeks, with flu season expected to strike with full force from December onwards. Those at risk include health workers, pregnant women, people suffering from chronic diseases and the population over the age of 65.
The flu season in Switzerland usually lasts from November to April and up to ten per cent of the population gets ill.
Over the course of the season, between 100,000 and 250,000 people consult a doctor, 1,000 to 5,000 end up in hospital, while 500 to 1,000 die from flu infections.
Healthcare costs related to influenza are estimated to around SFr100 million ($107 million) annually. Indirect costs, including economic losses, are worth around SFr300 million.
This year’s flu vaccination provides protection against three virus strains:
Influenza A / H1N1 (California/7/pdm09)
Influenza A / H3N2 (Victoria/321/2011)
Influenza B (Wisconsin/1/2010)
Source: Federal Health OfficeEnd of insertion
This article was automatically imported from our old content management system. If you see any display errors, please let us know: email@example.com