Novartis denies problems with swine flu vaccine
October 26th, 2009
Swiss pharmaceutical group Novartis on Monday denied that it faced hurdles in gaining regulatory approval in Switzerland for one of its swine flu vaccines because of possible bacterial contamination.
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.