Initial Results Show Nasal Flu Vaccine Is Safe

[webfact]

Initial results show nasal flu vaccine is safe

By Pongphon Sarnsamak

The Nation

Published on January 30, 2010

Initial results show nasal flu vaccine is safe

BANGKOK: -- Preliminary results show a locally made nasalspray vaccine for typeA (H1N1) influenza manufactured by the Government Pharmaceutical Organisation to be safe in volunteers, board chairman Dr Vichai Chokewiwat said yesterday.

Meanwhile, the Public Health Ministry will go ahead and provide inactivated flu vaccine imported last year from French manufacturer Sanofi Pasteur to people in highrisk groups, including pregnant women.

Vichai said researchers from Mahidol University's Faculty of Tropical Medicine had already finished conducting the first phase of human trials to test the live attenuated vaccine on 24 volunteers, to study its safety and immunogenicity. Final results will be announced next week.

As the preliminary result, He said the Data and Safety Monitoring Board (DSMB), who monitor the human trial, has informed him that the local made live attenuated vaccine is safe in human trial whether provide to volunteer with high dose of vaccine or low dose of vaccine.

The DSMB is now studying the immunogenicity response of vaccine and the result is expected to release next week.

GPO has begun its first phase of human trials to test live attenuated vaccine on 24 volunteers to study safety and immunogenicity since December 18, 2009.

All data collected will be submitted to the DSMB and the Ethical Review Committee before approving the second part of the study involving 400 participants. After that these committees will help the GPO to determine the dosage amount of the vaccine that will be used for production in greater quantities.

Over the past week, another 46 people have come down with the typeA (H1N1) virus Khon Kaen, Angthong, Chanthaburi, Chon Buri, Samut Prakan and Chiang Mai.

The Public Health Ministry, however, confirmed that the influenza had not claimed any lives between January 18 and 24, though the risk is still there.

Since the typeA (H1N1) influenza was detected in Thailand, it killed as many as 198 people to date.

To tackle with the second wave of the influenza type A (H1N1) outbreak, the Public Health Ministry has launched its vaccination program providing flu jap to nearly two million people in high risk group including medical worker, pregnant women, people whose weight over 100 kilograms, people with chronic disease, and disable people.

Public Health Ministry reported that 83,165 people have gone for their vaccinations since it was made available on January 11. Of those who have been vaccinated, only 52 people have developed minor side effects.

The ministry also reported that 7 out of 52 are now being investigated for the cause of severe complication and 5 among seven people were pregnant women.

Regarding to the news report that a pregnant woman in Satun province had develop severe complication and miscarriage a few days after receive the 2009 flu vaccine, Disease Control Department's senior health expert, Dr Suppamit Chunsutiwat said the cause of pregnancy complication is now being investigated and the result will be shown next week.

Meanwhile, the health condition of a Phattalung woman with five months pregnant now has been improved after she developed inflammation in her lung three days after received a flu jab. Her baby was safe and still admitted at Songklanagarind hospital.

Doctor believes the mother might be suffering from systemic lupus erythematosus (SLE).

Citing to World Health Organisation's flu vaccination program monitor report, Disease Control Department's spokesperson, Dr Opas Kangawinpong said the complications in pregnant women after receive vaccine against the 2009 influenza type A (H1N1) had been reported worldwide.

About 25 pregnant women in Canada had been reported that they appear complication after receive flu jab while Taiwan has reported 19 pregnant women with complication from vaccine and Denmark had reported two pregnant women suffer from side effect from flu vaccine.

However, Suppamit said the ministry will go ahead providing the 2009 flu vaccine to people in high risk group.

-- The Nation 2010-01-30

[newsfooter][/newsfooter]