Friday, May 23, 2008

Vietnam's Vaccine Trial Continues Without Incident

 


# 2015

 

Testing a new, experimental, vaccine is always worrisome.  Adverse side effects are always possible, and if they occur early in the testing among a small group, they can scuttle months or years of work.

 

The first 30 human volunteers in the vaccine trials have now received their second inoculation, and none have reported any serious side effects.  

 

While there is still more testing on these test subjects to come, if no complications arise, they will begin 2nd phase testing on 240 volunteers later this summer. 

 

 

The headline below is a bit misleading; their hope is to have the vaccine approved and ready to distribute in 2009.

 

 

 

 

Vietnam about to market H5N1 vaccine

16:51' 23/05/2008 (GMT+7)

VietNamNet Bridge – The Army Medical Institute has successfully tested the second dose of type A/H5N1 vaccine on 30 volunteers. Experts say Vietnam can mass produce this vaccine in 2009.

 

Thanks to volunteers, the testing process is being quickened. A volunteer, student Nguyen Van Quyet, said he learned of the testing of H5N1 vaccine from his mother, a health worker in the northern province of Ha Tay, and he registered to take part in the test.

 

“I believe in the quality of locally-made vaccine and I hope it will be put into wide use early. My health is very good. Several hours after the injection, I could play sports,” Quyet said.

 

A student at the Army Medical Institute, Nguyen Quynh Tu, said: “I want to contribute to the A/H5N1 vaccine research process so I registered to be a volunteer.”

 

Associate Professor, Doctor Doan Huy Hau, of the Army Medical Institute, said: “In science, we can’t make predictions but till now 23 students and seven colleagues of mine haven’t shown any side effects since their injections and this partly demonstrates the safety of the vaccine produced by the Vaccine and Bio-medical Company 1.”

 

Hau said the institute prepared a team of scientists and doctors who are ready to help volunteers in case of negative side effects but they were “unemployed”.

 

Doctor Pham Ngoc Hung at the Army Medical Institute, a volunteer, said: “That is a success that we didn’t dare to imagine before the test.” Hung has joined many vaccine tests and he said the H5N1 vaccine has shown the least side effects.

 

Volunteers are still under watch of scientists. Their blood will be tested three more times to confirm the safety of the vaccine.

 

If the first phase of testing is successful, the Health Ministry will permit the second phase of testing on 240 volunteers.

 

Dr. Hau said the second phase would be much more complicated since the number of tested volunteers would be 8 times more than for the first phase. Moreover, they will be under watch for up to 90 days, one month more than during the first phase.

 

Scientists hope that Vietnam’s H5N1 vaccine will be marketed in 2009.

 

Before Vietnam, only three countries tested H5N1 vaccine on humans, the US, China and Hungary.

 

There have been a total of 104 H5N1 patients in 35 provinces of Vietnam so far, with 50 deaths. The fatality ratio of this disease in Vietnam is 50% compared to the world average of 62%.