Novartis is sure that its flu vaccines manufactured in Italy are safe, despite the precautionary halt to deliveries ordered by Switzerland’s drug watchdog, Swissmedic, on Wednesday after the discovery of “possible impurities” in two of them.
CEO Joseph Jimenez said on Thursday that he did not expect sales to be halted in the near future, although this could not be ruled out.
Swissmedic said in a statement that at most 160,000 vaccine doses were affected, 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.
But it said those who have already received the vaccines have nothing to be concerned about.
The Italian health ministry has advised citizens not to buy or use the drugs Agrippal, Fluad, subunit Influpozzi and adjuvanted Influpozzi until further notice.
The move came after the Italian Pharmaceutical Agency decided further tests on the products may be necessary following indications of possible side effects.
A press release on the Novartis website said the Italian health ministry had acted after the company itself reported the presence of small particles in the vaccines.
According to Swissmedic, the presence of the particles could suggest some of the components of the vaccine had clumped together.
“Novartis confirms that these particles can occur in the vaccine manufacturing process and is confident that there is no impact on the safety or efficacy of the vaccine,” the Novartis release said.
It said it had supplied the Italian authorities with its own assessments of the quality, efficacy and safety of the vaccines in question, and would continue to work with them to make the vaccines available.
On Thursday the German authorities ordered a recall of some of shipments of the vaccines, also describing this as a precautionary measure.
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.
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 (Victorie/321/2011)
Influenza B (Wisconsin/1/2010)
Source: Federal Health Office