GlaxoSmithKline reports breakthrough on bird flu vaccine
Date: 15.8.2006
British pharmaceutical group GlaxoSmithKline (GSK) reported Wednesday a "breakthrough" in trials of a vaccine to combat a lethal strain of bird flu in humans.
The company signalled that although more work was needed, the vaccine was nearly ready for submission to regulators and then for mass sale.
"All being well, we expect to make regulatory filings for the vaccine in the coming months," GSK chief executive JP Garnier said in a statement.
GSK said that governments could order the vaccine for the H5N1 virus for delivery and stockpiling in early 2007 if it was approved by US, European and other regulators, even though more development work had to be done.
Speaking on BBC Radio, Garnier hailed the development as "a big breakthrough" and said his firm could produce hundreds of millions of doses by Christmas.
Citing the key for mass manufacture, the firm said its vaccine produced a high immune response at a low dosage because of a special "adjuvant" -- an ingredient which stimulates the body's immune system.
It said the vaccine had proved effective at two doses of 3.8 micrograms during clinical trials involving 400 healthy adults aged between 18 and 60 years old in Belgium.
"The meaning of this is that we are going to be in a position, starting later this year, to produce hundreds of millions of doses of an effective pandemic vaccine, so this is a big breakthrough," Garnier told BBC radio.
"We do not know what it would cost because we still have one unknown, which is we have to industrialize the process to make the vaccines," he added.
"But I would say if you were a betting man, you would say probably it's going to be equivalent to a flu vaccine in terms of cost - maybe four pounds (7.35 dollars, 5.84 euros) a dose or so," he said.
"We need a little more time to answer those questions but by Christmas we will be able to do so," he said.
"If we had a pandemic threat -- an immediate threat -- and we needed to switch from flu to pandemic, then we would make significant quantities very quickly."
During a conference in Paris last month, researchers warned of the difficulty of meeting demand in the event of a pandemic.
"We lack the manufacturing capacity to make enough doses of vaccines for the 1.2 billion people who may be at risk in a pandemic," Suryaprakash Sambhara, a researcher with the US Centers for Disease Control and Prevention (CDC) said.
Glaxo claimed that no other H5N1 vaccine in development has managed to prompt such a strong immune response with similar levels of antigen dosage.
French pharmaceutical firm Sanofi Aventis has also been working on a vaccine.
Among work still needing to be done before mass production begins involves assessment of its ability to offer cross-protection to variants of the H5N1 strain, according to Glaxo.
Asked if the vaccine could deal with a possible mutation in the virus that meant it passed from human to human, Garnier replied: "If you had a mutation that is closely connected to the H5N1 virus, the answer is probably yes."
However, if it mutated into a completely different kind of virus, the vaccine would probably not be effective, he told BBC radio.
"But the work that we have done would be very helpful because we would be in a position now to immediately produce the new vaccine as soon as we have identified the new virus," he said.
In its form today, the H5N1 virus is carried by poultry and passed to humans in close proximity. With rare exceptions, the human chain of transmission does not go further. Around 130 people have died since the scare erupted in 2003.
Garnier said GSK was talking to the Gates Foundation and other organizations about how to distribute the vaccine to poorer countries which have been hard hit by the H5N1 virus. "We need to find a source of funding," he said.
"Source":[ http://www.physorg.com/news73124139.html]
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