WRAL Tech Wire

Novartis produces first batch of swine flu vaccine; GSK continues research

Related Stories

• Novartis flu vaccine plant boosts Holly Springs' economy
• Novartis gets $486M contract for Holly Springs plant

On The Web

• Novartis

Site Search

Swiss pharmaceuticals company Novartis AG (NYSE: NVS) said Friday it has successfully produced a first batch of swine flu vaccine weeks ahead of expectations.

However, it's not being made - yet - at the new vaccine plant the company is building in Holly Springs. It's being produced in Germany.

The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said.

"Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations,"Novartis said in a statement.

The 10-litre batch "will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials."

GlaxoSmithKline (NYSE: GSK), meanwhile, says it continues to test potential vaccine candidates and foresees availability of a product within four to six months.

"In addition to increasing production and supply of the anti-viral medication, Relenza, the company continues to focus efforts on the development of a candidate A (H1N1) adjuvanted influenza vaccine," GSK said in a statement Friday.

"Following receipt of the seed strain from the WHO at the end of May, the company has begun the process necessary for development of the new vaccine at both the Canadian and German manufacturing sites," the company, which maintains its U.S. headquarters in the Research Triangle Park.

"The first step for manufacturing an influenza vaccine is to prepare the seed strain for production, which will take several weeks," GSK added "The company will then start production of the new candidate A (H1N1) influenza vaccine. The first doses of the A (H1N1) vaccine antigen are expected to be available in four to six months time, subject to regulatory approval."

"The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak," said Novartis Vaccines and Diagnostics Chief Executive Officer Andrin Oswald.

"This achievement is also a testament to the technical skills and innovation of Novartis Vaccines and Diagnostics people and our partners," he added. "I believe it highlights our reputation as a leader in influenza vaccine research, development and production."

The announcement comes a day after the World Health Organization declared swine flu, also known as A(H1N1), a pandemic. The move indicates that a global outbreak is under way. WHO says drugmakers will likely have vaccines approved and ready for sale after September.

Novartis expects clinical trials to start in July.

The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week.

Novartis said more than 30 governments have requested vaccine supplies, including the U.S. Department of Health and Human Service, which placed a $289 million order in May.

The company noted that development of Novartis' cell-based influenza vaccine and construction of the cell-based influenza manufacturing facility in Holly Springs is being supported by funding from the U.S. government.

In January, Novartis won a $486 million contract for its flu vaccine plant in Holly Springs.

The U.S. Department of Health and Human Services granted the eight-year contract to operate a vaccine manufacturing site that could respond to potential pandemics.

Novartis said more than 300 people would work at the plant by 2012. The plant will be used to develop a new flu vaccine using cell cultures. Existing vaccines are derived from eggs, which can take up to nine months to produce and are susceptible to the avian flu virus.

Biotech & Life Science

The latest biotechnology and life science news. Read more articles…