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2022-8-8 5:20:08


Thailand:Ministers at odds on flu vaccine test
submited by kickingbird at Mar, 5, 2005 8:18 AM from Bangkok post

Thailand is pressing ahead with a plan to conduct joint trials of a human vaccine against avian flu in Thailand with the US Centres for Disease Control and Prevention (CDC), Public Health Minister Sudarat Keyuraphan insisted yesterday.

But other ministers were much more cautious about the contentious issue.

Mrs Sudarat yesterday approved in principle the holding of bird flu vaccine tests on humans in the country.

Other ministers and health officials cautioned for due process to be carried out, but health ministry officials insisted that it was within Mrs Sudarat´s power to unilaterally approve the US request.

``The testing of a bird flu vaccine on humans is essential as long as Thailand and countries in the region are still at risk of a bird flu outbreak and a global influenza pandemic,´´ Mrs Sudarat said.

She said the ministry had enough samples of the lethal H5N1 strain of the avian flu to conduct vaccine tests on humans.

But Deputy Prime Minister Chaturon Chaisaeng gave a very cool reception to the idea of human tests saying the proposal had only been made via an e-mail from the CDC in Atlanta.

The Thai Food and Drug Administration (FDA) and the National Vaccine Supervisory Committee were duty bound to consider it through normal procedures which would take at least two months.

``We need to know a lot of details. Will the [test] process be of the same standard as in developed nations? How safe will it be?´´ he said, adding human safety was of paramount importance.

He said testing would have to wait, in any case, until a new cabinet was formed to take charge of events.

But Mrs Sudarat said she would push ahead and discuss the joint plan and framework for vaccine tests with the Medical Sciences Department on Monday.

In Thailand, 12 people have died so far from bird flu. An index case of probable human-to-human transmission between an 11-year-old girl, Sakuntala Prempasee, and her mother, Pranee Thongchan, has also been identified in the northern province of Kamphaeng Phet.

Health and scientific experts from the Medical Sciences Department, the Disease Control Department, the Government Pharmaceutical Organisation, Siriraj Hospital and the National Centre for Genetic Engineering and Technology also agreed with preparations for vaccine studies on both human influenza and bird flu, said Prasit Palittapongarnpim, deputy director of the National Centre of Genetic Engineering and Technology.

They believed Thailand would not be able to stockpile sufficient vaccine quantities to protect people if the study was carried out elsewhere, putting the country at risk in the event of a human pandemic occurring in the region, he said.

Bird flu has cost the country about 4.3 billion baht in economic damage in addition to the 2.2 billion baht compensation the government paid to farmers for the mass chicken cull in January 2003.

Paijit Warachit, the Medical Sciences Department director-general, earlier said he had talked to the US CDC in Atlanta about the safety of the vaccine and its possible clinical effectiveness.

But he said details about the benefits the country would receive from the study on a preventive bird flu vaccine for humans had yet to be discussed.

Prasert Thongcharoen, chairman of Thailand Influenza Foundation, believed approving trials of a preventive bird flu vaccine would give the country a head start in terms of having an effective tool to control the spread of the virus.

However, he said it was necessary for the government to pin down what Thailand would get in return before the experiments took place.

He said the right to use the vaccine at cheap prices if the trials proved to be successful was crucial.

The country should also gain scientific know-how to develop research and development technology rather than allowing private sector companies to exploit the benefits of the studies, he said.

Malinee Sukvejworakit, adviser to the Senate committee on public health, also warned that the government should learn lessons from previous HIV/Aids studies on humans to protect the safety of the Thai people before undertaking any human trials of bird flu vaccines.

The Senate would also be monitoring government movements on vaccine testing very closely to protect the welfare of test volunteers, she said.

Scott Dowell, director of the Thailand MOPH-US CDC Collaboration, insisted Thailand should also stockpile the anti-viral drug oseltamivir.

He said this was so that there would be an agent to work against the deadly virus strain before the vaccine was ready.

Thawat Sundarachan, the Disease Control Department director-general, said yesterday Deputy Public Health Minister Suchai Charoenrattanakul had received only one e-mail from the CDC in Atlanta, the issue was still being coordinated and there had been no government-to-government agreement so far.

He said the FDA would register the vaccine only for experimentation, then a human test committee of the director-general of the Medical Services Department would decide on the test process and finally approval from the national vaccine committee under the prime minister would be needed.

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