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WASHINGTON (Reuters) - U.S. health officials have approved vaccines from four drugmakers to help prevent the H1N1 swine flu, ensuring there will be enough to inoculate Americans who want the protection, U.S. Health Secretary Kathleen Sebelius told lawmakers on Tuesday.
The U.S. Food and Drug Administration cleared vaccines from Sanofi-Aventis SA, CSL Ltd, Medimmune and Novartis AG for the H1N1 strain of influenza, she said.
According to a report by Marc Badertscher in the Swiss newspaper, the Tagesanzeiger, the Swiss authorities have decided not to authorise the use of Novartis's swine flu jab "Celtura" on the grounds that there are insufficient studies to show it is safe, especially for women and children.
According to the report from the print edition, dated Saturday 24th October (Schweinegrippe: Novartis hat Problem mit Impfstoffzulassung) tests on Celtura found that the the dog based cell vaccine was contaminated with bacteria from dogs.
The Swiss government had ordered 5 million doses of Celtura, a drug that appears to be a repacked version of Aflunov/Fluad H5N1, which seems to have been responsible for killing people in Poland in clinical trials in 2008.
The vaccine, branded as Celtura, is produced by a technique using cell cultures from dog kidneys, allowing more rapid production than by the more classical method using chicken eggs, according to the company.
Citing anonymous sources close to the case, the Swiss daily Tages-Anzeiger reported on Saturday that the Swiss authority overseeing medicines and therapeutical products, Swissmedic, had found bacterial contamination in test batches of Celtura.
A spokesman at Swissmedic told AFP that the agency could "neither confirm nor deny" the report.
Swissmedic is due to give its authorisation for the vaccine this week ahead of a mass vaccination campaign against influenza A(H1N1) in Switzerland.
A spokesman for Novartis, Eric Althoff, insisted on Monday that the Celtura vaccine was not contaminated.
"There is no contamination of Celtura, the process is much cleaner than by chicken eggs," he told AFP.
Novartis is hoping for the green light to market the vaccine from Swiss health authorities in the coming days and from the European Union in the next few weeks.
The spokesman insisted that the production process was the same as that which has been used on a seasonal flu vaccine for several years.
About 8,000 people have taken part in clinical trials of A(H1N1) vaccines, he added.
Novartis already markets another swine flu vaccine in Europe under the brand name Focetria, which is based on chicken egg cultures.
Originally posted by PsykoOps
More of this kind. Goes to show how powerfull those big pharma guys really are when there is no visible opposition to the vaccinations. I just read that they have plans for mandatory vaccination in my country too. Untill now I thought we were on the clear. I for one wont take the vaccine and will fight it to my last breath. They can then stick the needle into my cold dead corpse.