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China 2nd COVID-19 inactivated vaccine approved with conditions
China 2nd COVID-19 inactivated vaccine approved with conditions. Following the conditional listing of the COVID-19 inactivated vaccine of the Beijing Institute of Biological Products of Sinopharm Group last year, on February 26, the China National Medical Products Administration approved the conditional listing of the COVID-19 inactivated vaccine of the Wuhan Institute of Biological Products. This is the second COVID-19 vaccine approved by China Biotech for conditional marketing.
From July 16, 2020, Wuhan Institute of Biological Products will carry out the “New coronavirus Inactivated Vaccine Phase III Clinical Trial” in the United Arab Emirates and other countries. The trial adopts an “international multi-center, randomized, double-blind, placebo parallel-controlled design” “. The results of the interim analysis of the phase III clinical trial showed that the safety of the new coronavirus inactivated vaccine from Wuhan Institute of Biological Products of China Biology was good.
After the two-shot immunization program, the vaccinated persons produced high-titer antibodies and neutralized antibodies. The rate is 99.06%. The protection rate of the COVID-19 vaccine against the confirmed moderate and severe diseases reaches 100%, and the total protection effect is 72.51%. It meets the relevant technical standards of the World Health Organization and the “Guidelines for Clinical Evaluation of New Coronavirus Preventive Vaccines issued by the State Food and Drug Administration” (Trial)” in the relevant standards.
The results of the cross-neutralization experiment of the phase III clinical trial of Wuhan Institute of Biological Products showed that the vaccine group’s serum and 10 strains of new coronaviruses circulating at home and abroad provided 100% cross-neutralization protection 28 days after the whole course of immunization, and the vaccine produced against the new coronavirus Antibodies have a wide range of cross-neutralization reactions against popular or representative COVID-19 wild strains at home and abroad.
Since February 1, 2020, as the lead unit, China Biotech has obtained the emergency approval of the key special “2019-nCoV inactivated vaccine” project of the Ministry of Science and Technology National Key Research and Development Program “Public Safety Risk Prevention and Control and Emergency Technology and Equipment”, and then China Biotech Wuhan The Institute of Biological Products and the Wuhan Institute of Virology of the Chinese Academy of Sciences quickly started cooperation and quickly launched the research and development of new coronavirus inactivated vaccines.
The research team has successively tackled the screening of vaccine strains, establishment of virus seed banks, antibody preparation and identification, establishment of detection methods, compatibility and A series of key technologies for the development, production and quality control of COVID-19 vaccines, including formula screening, production process research, etc., determined the process technology route and product quality attributes, and quickly carried out and completed animal experiments and safety and effectiveness evaluations.
On April 12, 2020, the Wuhan Institute of Biological Products of China Biosciences obtained the world’s first clinical approval for an inactivated new coronavirus vaccine and simultaneously carried out clinical trials of I/II. The statistical results show that the safety of the vaccine is good after vaccination; different procedures, different After dose vaccination, all the vaccinated persons in the vaccine group produced high-titer antibodies. On June 23, the UAE Minister of Health issued a clinical trial approval document to China Biotech, marking the official launch of the world’s first international clinical trial (Phase III) of the COVID-19 inactivated vaccine. On June 30, the first batch of the vaccine was put into emergency use, and emergency vaccinations were successively carried out for specific populations in China.
▲China’s new biological COVID-19 vaccine UAE Phase III clinical trial site
Wuhan Institute of Biological Products has built a biosafety workshop for the COVID-19 inactivated vaccine. After inspection and certification by the relevant state departments, it has been put into large-scale production, with an annual output of up to 100 million doses. The most powerful weapon for mankind to compete with disease is science and technology. Mankind cannot overcome catastrophes and epidemics without scientific development and technological innovation. This time, another inactivated COVID-19 vaccine developed by China Biology has been approved for conditional listing, which will further strengthen the confidence of some countries’s health and anti-epidemic barrier, and contribute more Chinese forces to the realization of the global affordability of the COVID-19 vaccine.
(source:internet, reference only)