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Novartis Denies Problems
With H1N1 Swine Flu Vaccine
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.
* A
full list of h1n1 vaccine ingredients, alerts and warnings.
Reference
Sources:
AFP
October 27, 2009
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