First vaccine against H1N1 virus from CSL to be available in 2 months

Australia’s CSL has already bagged orders worth $180 million from US govt.

The first-ever vaccine shots against the deadly swine flu causing H1N1 virus strain will be made ready by Australia’s leading biotech firm CSL Ltd by mid August, according to company officials.

CSL Ltd could be the first company to launch H1N1 shots in record time surpassing several other top line vaccine makers in the world including Sanofi-Aventis SA and GlaxoSmithKline Plc who are in the fray.

H1N1 vaccine shots from Sanofi-Aventis SA, GlaxoSmithKline Plc and AstraZeneca Plc’s MedImmune may not be ready for market only by September or October, reports said.

Countries around the world are desperately looking for a preventive vaccine against the swine flu as the lethal H1N1 infection spreads rapidly across the continents.

The pace of spread of H1N1 infection pushed the World Health Organization to declare swine flu as pandemic. H1N1 is the first influenza infection to be declared for a pandemic alert in the last four decades.

Announcing the need for a pandemic alert on Wednesday, WHO urged the drug makers to commence the commercial production of H1N1 vaccine shots as quickly as possible.

“We would advise them, as soon as they finish their seasonal vaccine production, to quickly prepare to make commercial-scale pandemic vaccine,” stated Margaret Chan, the WHO’S director-general.

CSL, which is the smallest among the six major vaccine makers who are currently working on H1N1 vaccines, is the only flu vaccine maker which develops its own seed viruses. No other company in the Southern Hemisphere of the globe has the capability to develop seed virus.

CSL started work on its swine flu vaccine on May 4, when it received its first live samples of the virus from the Atlanta- based Centers for Disease Control and Prevention.

Seed viruses are injected into fertilized eggs to make a vaccine as the viruses need a living cell to grow. The virus is then extracted, purified and killed. This attenuated or weaker forms of the virus are then prepared as vaccines to boost the immune system without causing disease.

CSL expects to finish making antigen for the seasonal shot by the end of June so that it can  start H1N1 antigen production in early July.

Last month, CSL’s US subsidiary, CSL Biotherapies, Inc signed a contract worth $180 million with the U.S. Department of Health and Human Services (HHS) to provide l A (H1N1) influenza vaccine antigen in bulk form. The vaccine will be manufactured at CSL’s facility in Parkville, Victoria, and will support the HHS pre-pandemic influenza preparation efforts. The new vaccine will be tested in clinical trials funded by HHS.

Started in Mexico, swine flu, formally known as H1N1, has sickened nearly 30,000 people in 74 countries.

The novel H1N1 virus preferentially infects younger people. In nearly all areas with large and sustained outbreaks, the majority of cases have occurred in people under the age of 25 years.

One third to half of the severe and fatal infections are occurring in previously healthy young and middle-aged people. Although the pandemic appears to have moderate severity in comparatively well-off countries, the severity can vary, depending on many factors, from one country to another.

Majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment. In most cases the virus causes little more than a fever and cough.

Headquartered in Melbourne, Australia, CSL Limited is a global, specialty biopharmaceutical company that researches, develops, manufactures and markets drug products. With major facilities in Australia, Germany, Switzerland and the U.S., CSL has more than 10,000 employees working in 27 countries. Founded in 1916 as a government laboratory for producing vaccines, the CSL Group has more than 90 years experience in the development and manufacture of vaccines and plasma protein biotherapies. When it was privatized in 1994, CSL retained its ability to prepare seed viruses. In fiscal year 2008, the company produced revenues of approximately A$3.8 billion.