SINOPHARM applies to sell COVID-19 vaccines
SINOPHARM applies to sell COVID-19 vaccines
SINOPHARM applies to sell COVID-19 vaccines. China SINOPHARM (China National Pharmaceutical Group Co., Ltd.) has submitted an application for marketing and sales of COVID-19 vaccine, and the production capacity may exceed 1 billion doses next year.
According to Xinhua Finance News on the 25th, Shi Shengyi, deputy general manager of China National Pharmaceutical Group Co., Ltd., said that SINOPHARM has submitted the application of selling COVID-19 vaccines to the State Food and Drug Administration.
On February 1, Sinopharm, as the lead unit, won the emergency approval of the key special inactivated vaccine project of the Ministry of Science and Technology National Key Research and Development Program “Public Security Risk Prevention and Control and Emergency Technology and Equipment”.
On April 12, the COVID-19 inactivated vaccine developed by Wuhan Institute of Biological Products was approved for clinical trials, and domestic phase I/II clinical trials were carried out simultaneously.
On April 27, the inactivated COVID-19 vaccine developed by the Beijing Institute of Biological Products was again approved for clinical trials, adding double insurance to the development of the COVID-19 vaccine.
In the domestic phase I/II clinical study, a total of 4064 people of each age group were included in the group. The unblinded results showed that the safety after vaccination was good. Different ages, different procedures, and different doses of vaccination all produced high titer immune responses. After two doses of the vaccine were inoculated according to the 0, 28 day program, the positive conversion rate of neutralizing antibodies reached 100%.
According to Liu Jingzhen, Chairman of Sinopharm Group, the two inactivated vaccines, Beijing Institute of Biological Products and Wuhan Institute of Biological Products, affiliated to Sinopharm Sinopharm, are now being launched in ten countries including the UAE, Bahrain, Egypt, Morocco, Peru, and Argentina. In Phase III clinical trials, more than 50,000 people have been vaccinated, and the total number of vaccinators will reach more than 60,000. The sample size of the vaccinated population covers 125 nationalities. The progress in all aspects is leading the world and has been widely recognized internationally. Now dozens of countries have put forward COVID-19 vaccine requirements to Sinopharm Group China Biotech.
After obtaining safety and protection data in phase III clinical trials, the vaccine can be marketed after review and approval. In fact, there are already vaccines in our country that have already begun emergency use. Both of the two inactivated vaccines of Sinopharm Sino Biotech have been included in the scope of emergency use.
According to reports, China National Biotech is ready for large-scale production. Two high-grade biosafety production workshops for the COVID-19 vaccine, Beijing Institute of Biological Products and Wuhan Institute of Biological Products, have been completed. The production capacity is expected to reach more than 1 billion doses next year. A safe and adequate supply of vaccines can be guaranteed.
