Novartis denies problems with swine flu vaccine

27th October 2009, Comments 2 comments

Novartis on Monday denied bacterial contamination of its new vaccine Celtura.

Geneva -- Swiss pharmaceutical group Novartis on Monday denied that it faced difficulties 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, 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 approval 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.

AFP / Expatica

2 Comments To This Article

  • b4blue posted:

    on 27th October 2009, 14:11:18 - Reply

    sure, and the contamination of vaccines for Slovenia and some other EU countries that contained bird flu virus, at the beginning of this year, but fortunately discovered by Austrian doctors before transport was also just ...what???
    Am I crazy or modern medicine sounds more and more like a dogmatic religion?
  • HTD posted:

    on 27th October 2009, 11:13:08 - Reply

    Continuous pyrogen testing is a standard requirement for all sterile products. Any and all 'hot' batches are removed from production and properly destroyed; such batches are certainly not allowed to be distributed for medical use. Such distribution would lead to very expensive lawsuits and the pharms understand that very well. This Pyrogen testing is used not only for flu vaccines, but for all pharmaceutals. I think we will find out shortly that what this Swiss agency found was a batch that was scheduled, but had not as yet been tested for pyrogens or had already been taken out of the production que for destruction.

    We must remember that newspapers and reporters are paid to sell information; even if there are important points omitted from their publications to be added later. Unfortunately, many only remember the first release and are not able to piece the later explanation back with the original incomplete report.