On April 2, 2008, the State Food and Drug Administration announced that the first person in China has used the H5N1 bird flu vaccine, Panflu, an inactivated pandemic influenza virus vaccine, for approval. And approve production. At present, the vaccine will be limited to national reserves and will not be marketed. In the event of a pandemic flu or during an emergency, the country will initiate vaccination for pandemic flu.
China's research is at the forefront of the world
In 2004, the world sent away the “god†SARS, but ushered in new challenges posed by human bird flu. As of April 8, 2008, there were 379 cases of human bird flu infections in the world, of which 239 were dead and the death rate was over 60%. In order to fight against bird flu, various countries have initiated the development of human bird flu vaccine. For this research, Chinese scientists have also been at the forefront of the world.
The approved pandemic influenza virus inactivated vaccine was jointly developed by Beijing Kexing Biological Products Co., Ltd. and the Chinese Center for Disease Control and Prevention. It is understood that the Phase I clinical study of the vaccine was completed in June 2006 in the China-Japan Friendship Hospital of the Ministry of Health. The results were published in the international authoritative clinical magazine The Lancet. In December 2007, Phase II clinical trials were completed. The results showed that the vaccine was safe and effective for the human body, and all indicators met the internationally recognized vaccine evaluation criteria.
Vaccine cultured in chicken embryos
Yin Weidong, general manager of Beijing Kexing Biological Products Co., Ltd., told reporters that the bird flu vaccine strain was constructed using reverse genetic technology, that is, the use of genetic engineering technology to transform the wild strain to make it non-pathogenic, but it can also stimulate the human body. Generate resistance. Then, the virus seeds are inoculated into the chicken embryos that have been incubated for 9 to 11 days and cultured. After the viruses are harvested, the viruses are inactivated and purified, and then a series of procedures are performed. Finally, a suitable adjuvant is added to prepare the vaccine.
It is understood that the newly developed human bird flu vaccine is suitable for 18-60 year-old people, the use of a dose of 10 micrograms / 0.5 ml / support, full immunization for the two needles. As the vaccine and the general influenza vaccine production process is basically the same, vaccinations contraindications are the same, namely, fever, acute illness, colds, acute exacerbation of chronic diseases, history of Guillain-Barre syndrome and allergic to eggs should not be inoculated.
Vaccines do protect
Professor Lin Jiangtao, director of the Department of Respiratory Medicine at the Sino-Japanese Friendship Hospital of the Ministry of Health, the head of the Phase I vaccine clinical study, told the Life Times that the most effective means of controlling the pandemic (including bird flu) pandemic is vaccination. At present, the global bird flu epidemic is mainly concentrated in Southeast Asia and China. Although it is distributed, it needs to be vigilant. The people approved this time have used bird flu vaccine and have proved to be protective by clinical trials. Even if the virus mutates, we have technical reserves, we can carry out vaccine transformation and production according to the existing procedures, and strive for time for the prevention and control of the epidemic.
Lin Jiangtao said: “At present, only Sanofi Pasteur, GlaxoSmithKline and several companies in Japan, Australia, and the Netherlands are mastering this technology, and our research is in sync with the world’s advanced level.â€
In the latest issue of the Lancet magazine, the Chinese Center for Disease Control and Prevention used a phase I clinical trial volunteer volunteer to donate plasma 280 days after the trial in the successful rescue of a case of bird flu. This also demonstrates the effectiveness of the vaccine from another perspective.