In 2009, there will be H5N1 vaccine

After more than four years of H5N1 vaccine research, scientists at the National Institute of Hygiene and Epidemiology (NIHE) have announced: next April, human trials will be conducted and 2009 will be officially available. on the market.

The last stages of the H5N1 vaccine

The good news for NIHE scientists, the Ministry of Health has agreed to allow testing on the H5N1 vaccine by Research Company and Vaccines No. 1, NIHE. The research, more than 4 years of research on the virulent H5N1 virus of scientists, has reached its final stage.

'' In early March this year, a group of NIHE scientists were the first to volunteer to test the H5N1 vaccine. And in April, 300 volunteers will be given the vaccine test, 'said Prof. Dr. Nguyen Thu Van, Director of the No. 1 Vaccine and Biopharmaceutical Company, chairman of the research project. newspaper.

The test participants were 103 Military Medical Academy practitioners. Currently all of the volunteers' test participants have been transferred to the Ministry of Defense to consider safety before use. The clinical trial process will be divided into 2 phases. Between the trials, blood collection will be conducted to see how effective the vaccine is. About 300 people participated in the test.

Although the research process is going to the final stages, there are still difficulties ahead.

Prof. Dr. Thu Van said more clearly about the human testing process in the coming time: The phase of clinical trial will be divided into 2 phases. The first trial will involve more than 30 people to assess how safe the vaccine is on people, if there is any reaction.

Scientists injected H5N1 vaccine into monkeys at Ruy island, Quang Ninh in 2004. (Photo document of the National Institute of Hygiene and Epidemiology)

The second phase continues to assess safety on a wider number of participants. About 300 people, (including the exclusion of people in the process of not participating in the final stage) to continue to ensure that the final assessment data is scientific enough.

The duration of the experimental injection period of 1 in 30 people with 2 shots 28 days apart. After 1 month of confirming safety, the Ministry of Health will continue to work in phase 2. Between the trials, blood collection will be carried out to see the safety of this vaccine. These two periods are expected to last for 8 months.

Vaccines must meet the standards for use for new licensees and officially put into production, expected at the end of 2009 if all goes well.

Now, I am looking forward to the final tests, Prof. Dr. Thu Van recalls: For a long time in research, the most difficult stage is testing on mice. This is a very important process because there is an immune response, but it is not necessarily safe, only when the person who is vaccinated is protected in the event of an exposure is the final result. .

For dangerous viruses such as H5N1, it is worrisome, especially for rapidly mutating viruses, that production vaccines are always behind. When the vaccine is born, it no longer works. This is what many people are worried about in the past. However, Prof. Thu Van affirmed: ' It is true that the H5N1 influenza virus strain has changed, but through NIHE decoding, these changes are very few. "The vaccine that the Institute is studying and producing from the 2004 strain still protects."

'' Even if it changes, it is more important in this topic of NIHE scientists to build a technological process. In the case of modified viruses will produce new strains and immediately put them into production ', Prof. Dr. Thu Van emphasized.

Journey of H5N1 vaccine "made in Vietnam"

In 1997, the "born" H5N1 virus in Hong Kong claimed six lives. In late 2003, it "traveled" to Vietnam and became a major threat to the people.

In the face of the danger of this virus, the World Health Organization (WHO) has warned that in the coming time, the bird flu virus could become a new strain with high virulence, human-to-human transmission, estimated. about 1-40 million people die. Together with scientists around the world, in mid-2004 a group of NIHE scientists began work on the production of the H5N1 vaccine.

After a period of research, on January 17, 2005, NIHE tested the H5N1 flu vaccine in mice, then continued with chickens and monkeys.

NIHE scientists say: the virus that causes disease in poultry and humans today (H5N1) has a very high virulence. At the request of WHO, this highly virulent virus should not be used to directly produce the vaccine, but to reduce its virulence or loss of virulence. If not, it is dangerous for those who directly study vaccines or harm the community during the research and testing process that do not guarantee biosecurity.

Monkeys - a kind of animal close to humans, have biological characteristics similar to those chosen as test subjects. Chickens - one of the birds capable of spreading high disease needs direct testing to be effective.

Unlike previous studies, which are usually cultured on chicken eggs with embryos. This time, the scientists implanted the virus on monkey kidney cells. The research conducted on monkeys will produce higher productivity and cleaner by not mixing impurities like on chicken eggs with embryos.

Only one month later, on February 17, 2005, another good news came: The first test of H5N1 vaccine in rats and chickens gave good results - both of which appeared antibodies. This proves an immune response.

H5N1 vaccine product is produced by the National Institute of Hygiene and Epidemiology called Fluvax.(Photo: Van Khanh)

Early successes such as mental medicine helped scientists continue to study. The joy continued to scientists, on February 25, 2005, after 3 weeks of injecting the vaccine in monkeys, all were still alive and well, proving that one thing can respond to immunity and safe vaccine. And now, after many studies with hundreds of animal tests, the human clinical trial is about to be carried out by scientists.

The H5N1 vaccine is expected to be researched by the No. 1 vaccine company and NIHE called Fluvax, the ex-factory price is only VND30,000 / dose, the price for vaccination is over VND40,000 / dose.

Le Ha