The H5N1 vaccine cannot be tested on humans because ... procedure?

The Ministry of Health must agree, the National Institute of Hygiene and Epidemiology (NIHE) has just been clinically tested. But the ministry also awaits the results of the World Health Organization (WHO) appraisal of the series of experimental vaccines. WHO is ready to bring experts to Vietnam to review the records after these documents are sufficient legal procedures of Vietnam .

People are looking forward to the H5N1 vaccine;The government also asked the Ministry of Health to speed up the process of completing the H5N1 vaccinein many meetings to prevent and prevent bird flu.

Exchanges of Prof. Dr. Nguyen Thu Van, Director of Vaccine and Biologicals Company No. 1 - NIHE ( VABIOTECH / NIHE) on the cause of delay of testing A / H5N1 vaccine on humans.

- NIHE is taking final steps on the path of H5N1 vaccine research . But it's not yet allowed to have a clinical trial on people. Is there still a problem?

- The Institute is ready to conduct clinical trials on volunteers but must be approved by the Ministry of Health. The Ministry of Health asked to wait for a reply from WHO about the results of the quality assessment of the series of vaccines sent to WHO, then proceed with the approval procedures for clinical trials.

Meanwhile, WHO has recommended that all legal documents and procedures should be prepared for submission to competent authorities for approval and if the Vietnamese side requests that WHO will send experts to appraise the reservoirs. This profile for clinical trials.

I think WHO only appraises to help us in terms of technical expertise, not deciding to support us in terms of state management.

- This delay caused many people to be "suspicious" about the process of producing H5N1 vaccine. In addition, is there information that the Institute's research proposal has been rejected?

That is incorrect information. To be more precise, the research proposal has not yet been approved and the Scientific Council proposes to add some more information (I think these are common things when approving a scientific research proposal). .

After that, there was a directive of the Ministry of Health and the Ministry of Science and Technology waiting for the comments of the WHO so that the situation has not been improved yet.

If we say it has been rejected, what do we research and wait for? The research protocol for producing influenza vaccines that we submitted to the Ministry of Science and Technology is too new for both domestic and international. Until now, world vaccine manufacturers have used traditional technology to produce chicken eggs with SPF ( Specific Pathogen Free) embryos , while NIHE produces influenza A / H5N1 vaccine on monkey kidney cells. play.

Around this technology approach there are certainly many opinions, but we have persevered and longed for an open and frank exchange between scientists and managers so that all issues are clear. , speeding up the progress of researching the production ofH5N1 vaccine in Vietnam faster and soon there isA / H5N1 vaccine to protect the community.

- There is an opinion that the Ministry of Health has not yet agreed to give the Institute a voluntary clinical trial because of unclear origin of the virus. How does GS explain?

- I think this opinion is incorrect. In the production of vaccines, viruses and vaccines are a prerequisite for success and very important. We cannot conduct research when the origin of the vaccine strain is unclear.

The strain of H5N1 vaccine virus that the Institute is using in research and development of influenza A / H5N1 vaccine is prepared at the National University Laboratory, Tokyo Japan under the direct guidance of GS. Yoshihiro Kawaoka, a leading expert on reverse genetics, has been granted the intellectual property (IP) license on this technique.

The vaccine strain we are using is full of technical specifications provided by WHO's H5N1 vaccine (NIBRG-14) and also has the same origin from the wild H5N1 virus isolated in Vietnamese patients. Nam signed A / Vietnam / 1194/2004 (H5N1) and was cut off the gene causing the disease. WHO on the trip to work with the Institute in August 2005, after assessing the production profile of VABIOTECH / NIHE, their assessment was reported in the report that VABIOTECH had sufficient scientific experience and facilities. substance to produce vaccines for human use.

In terms of raw materials, VABIOTECH / NIHE uses primary monkey kidney cells, but if using eggs with embryos, it must be "clean" chicken eggs, which means not to bring specific SPF pathogens. As for monkeys to select clean monkeys, the appraisal of the monkeys is not required, not all monkeys can be included to produce vaccines, but must be clean monkeys. We have to eliminate the monkeys' foreign agents according to WHO technical guidelines for selecting clean monkeys for the production of live oral polio vaccine.

- So far, the requirements WHO has made, how far has it been?

- WHO has issued 9 requirements in the process of research, vaccine production is to send vaccine samples to WHO; antigen test in finished vaccines before clinical trials; prepare technical documents for transfer to the National Accreditation Center; send a file to assess foreign virust in monkeys; write a scientific article on the project to be published in a prestigious magazine of the world; plan if production is expanded; regularly discuss with WHO about research work (month / time); If there is a request for assistance with appraisal of WHO, it will help.

So far the above requirements have been completed. At this time, every week in the third week WHO and the Institute have had regular discussions.

- The Institute is planning to test clinical influenza A / H5N1 vaccine on people in early 2006, but it seems that this plan failed .

- In principle, a production researcher cannot conduct a clinical trial on a volunteer because it is not objective to self-assess the vaccine made by himself, but must contract with a muscle Authorities conduct this.

After permission from the Ministry of Health for clinical trials and the results of clinical trials are good, we continue to apply for circulation of products before being licensed for circulation and officially go into production. export. It is a mandatory process for any newly developed vaccine.

However, the Institute has prepared enough volunteers to apply for clinical trials. Phase 1 has about 20 people, phase 2 is 250 people. These are people in the age of 18-45, fully meeting some selection criteria, completely healthy, not exposed to infected or non-infected poultry.

- Does it mean that everything is prepared, just waiting for a decision on a clinical trial on humans?

- Right. However, this time should not be tested in the field because it is the peak of the epidemic; and if the situation is urgent, it must be done with caution. Testing will proceed at the appropriate time. At this rate, it must have been completed by the end of 2006.

- Thank you GS!

Le Ha (done)