GSK encouraged by first H1N1 vaccines results
pharmafile | September 15, 2009 | News story | Sales and Marketing |Â Â GSK, h1n1Â
Results from the first trial of GlaxoSmithKline's new pandemic swine flu vaccine have been revealed.
A German study of 130 healthy volunteers found patients' immune response after one jab exceeded the immunogenicity criteria defined by licensing authorities, GSK said.
"This trial provides encouraging data on the potential use of a single dose of our pandemic vaccine," explained Jean Stephenne, president of GSK Biologicals.
The company is using antigen of the isolated pandemic (H1N1) 2009 flu strain in combination with it own adjuvant system AS03, which will allow more doses to be produced.
The trial shows this performed slightly better than an unadjuvanted test study formulation three weeks after vaccination.
The adjuvanted vaccine demonstrated hemagglutination-inhibition titres with a 1:40 seroconversion – the development of antibodies – in more than 98% of subjects, compared to 95% in the unadjuvanted group.
"We have shared these data with both regulatory authorities and governments who are making key decisions on urgent global public healthcare at this time," Stephenne added.
The antigen content of the trial adjuvanted vaccine is 5.25ug, with a final formulation expected to be 3.75ug.
Stephenne said the firm now aims to complete this trial, along with 15 other studies with 9,000 subjects across Europe, the US and Canada and will post all results on its Clinical Study Register.
GSK is among a knot of companies looking to develop an H1N1 vaccine to combat the pandemic, the spread of which the World Health Organisation says is unstoppable.
The manufacturer has deals to produce 195 million doses to governments worldwide.
In response to criticism of the company, chief executive Andrew Witty insisted earlier this year that it will not attempt to "generate some crazy level of profit" from the pandemic.
But he pointed out that GSK has spent £1.2 billion on vaccine technology in the last four years.
However, GSK is expected to be one of the biggest producers of H1N1 flu vaccines worldwide and already markets an antiviral, Relenza.
Sanofi-Pasteur MSD, Baxter, Novartis and MedImmune are among its big rivals in the hunt for a new vaccine.
Australia-based CSL and Chinese firms Hualan Biological Engineering and Sinovac Biotechnology are also developing their own candidates.
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