Switzerland’s drug watchdog has ordered a precautionary halt to deliveries of flu vaccines made by Novartis after authorities in Italy banned their use and import on Wednesday due to possible side effects.
Swissmedic said it was acting was due to „possible impurities,“ in Agrippal and Fluad. At most 160,000 vaccine doses were be affected, it said in a statement, adding that it had acted immediately being informed by the Italians.
„Given the current unclear situation Swissmedic has issued a halt on deliveries for the cited vaccines and recommends not using them until further notice,“ the agency explained.
However the measure is considered precautionary until the situation is clarified and those who have already received the vaccines have nothing to be concerned about according to Swissmedic.
Preliminary investigations had shown Italy’s ban came after the discovery of white particles in the injections, which could suggest some of the components of the vaccine had clumped together, Swissmedic said.
Italy has banned the sale and use of anti-influenza vaccines produced by Novartis pending tests for possible side effects. The Italian health ministry advised citizens not to buy or use the drugs Agrippal, Fluad, subunit Influpozzi and adjunvated Influpozzi until further notice.
It said 487,738 vaccine doses were affected, and the move came after the Italian Pharmaceutical Agency decided further tests on the products may be necessary following indications of possible side effects.
Cooperation
Novartis said in a statement that it was cooperating with Italian health authorities to understand the reasons behind the decision, and it had already provided authorities with an assessment in support of the quality, efficacy and safety of the vaccines.
Last week, Italy’s health ministry said Netherlands-based vaccine maker Crucell, a unit of American drugmaker Johnson & Johnson, had suspended a delivery of seasonal flu vaccine doses to Italy after finding problems with two batches. Deliveries to the rest of Europe were also suspended.
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.
On Tuesday, 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 due to Crucell’s problems. The office has confirmed though that between two thirds and three quarters of the ordered doses have been delivered so far.
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.
Flu season in Switzerland usually stretches 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 (Victorie/321/2011)
Influenza B (Wisconsin/1/2010)
Source: Federal Health Office