TYPE A(H1N1) -Vaccine proves to be safe for human trial

GPO to launch FluMist tomorrow; victims on the rise

The Government Pharmaceuti-cal Organisation will next month start undertaking human trials on the live-attenuated vaccine against the type-A (H1N1) virus now that laboratories in the Netherlands and Russia have confirmed the virus-seed vaccine proved to be safe on animals, GPO's board chairperson Dr Wichai Chotewiwat said yesterday.Meanwhile, he added, that tomorrow the GPO would be coming up with the first few doses of FluMist, a nasal spray live-attenuated vaccine. The Public Health Ministry announced last week that the number of swine-flu victims had risen to 81 after 16 more patients succumbed to the virus. The ministry said it is suspected more than 500,000 people have been infected, and that the death toll was closer to 100 people.In a bid to tackle the outbreak, the Public Health Ministry and Mahidol University's ethics committees have, in principle, given the university's Faculty of Tropical Medicine the green light to research the vaccine.Citing a recent e-mail from laboratories in the Netherlands and Russia, Wichai said so far the virus-seed vaccine had been tested for safety and toxicity on mice and ferrets, and that a human trial would be launched in Thailand next month."The e-mails say that the virus-seed vaccine proved to be safe on animals and that there were no toxins or mutation," he said.The GPO will also be incubating the virus to make sure it is free from contamination before it is tested on some 400 volunteers from September 4. So far, about 100 people have volunteered for the trial, he said.In a bid to ensure safety of the volunteers, Wichai said the ministry's Ethical Committee would also set up a data and safety monitoring board. The World Health Organisation's regional office, based in India, will send a representative to help the ministry set up this board, while WHO staff members will work along with Thai researchers to monitor the safety and efficacy of the vaccine. The panel, which is still closely studying details of the project, has until today to decide on whether or not to allow the vaccine to be tested on humans.A recent report from the Ramathi- bhodi Hospital says that samples collected from a patient, who has already recovered, show that the type-A (H1N1) virus is resistant to the oseltamirvir antiviral drug.However, the ministry's advisory committee, chaired by leading virologist Prasert Thongcharoen, insisted that the evidence was not enough to confirm the virus is resistant to the drug, because the study was only done on the change to the virus gene's genetic position. He added that research had not been done on enough samples to confirm the virus was resistant."More samples need to be tested before we can confirm the virus is resistant," he said.However, Public Health Minister Witthaya Kaewparadai said just to be safe, he would reserve up to 100,000 courses of the second drug zanamivir.

Source: The Nation