Argentina has been Added to the Phase III Clinical Trial of the Chinese-Made New Coronavirus Vaccine -- Three Countries in Two Days

On the evening of August 21, Sinopharm China Bio -- New Coronavirus Vaccine International Clinical (Phase III) signed a clinical cooperation agreement with Argentina.

Sinopharm after obtaining the UAE clinical trial approval on June 23 and the Peru and Morocco clinical trial approvals on August 20, Argentina is the third. International cooperation on the clinical research of the vaccine has been significantly accelerated, which will help it 'be on the market before the end of this year at the earliest.'

Back on April 12, in terms of new coronavirus vaccine research and development, the new coronavirus vaccine developed by Sinopharm's Wuhan Institute of Biological Products entered the first phase I/II clinical trial in the world. On April 27, Sinopharm's Beijing Institute of Biological Products R & D for the new coronavirus vaccine has also entered phase I/II clinical trials.

According to Liu Jingzhen, Chairman of Sinopharm Group, a total of 2,240 people were enrolled in the Phase I/II clinical studies of the two vaccines. They were revealed to public on June 16 and 28 respectively. The results showed that the vaccine was safe after vaccination and there was no obvious adverse reaction; After vaccination of different ages, different procedures, and different doses, high-titer immune responses were produced. The two COVID-19 vaccines lead the world in terms of product performance such as safety and effectiveness.

He explained that clinical research is usually divided into three phases: Phase I mainly evaluates safety; Phase II mainly evaluates vaccine safety and immunogenicity, while exploring immunization procedures; Phase III mainly evaluates vaccine safety and safety in a larger population. Effectiveness. 'In view of the effective control of the domestic epidemic situation and the lack of conditions for phase III clinical trials, Sinopharm Group has actively promoted overseas cooperation for phase III clinical trials while solidly completing domestic phase I/II clinical trials, and signed cooperation framework agreements with relevant institutions in many countries.'

As for the issue of the new genotype caused by the mutation of the new coronavirus that the public is very concerned about, it may 'lead to weakened or even ineffective vaccines'. Yang Xiaoming, chief scientist of the National 863 Program vaccine project and chairman of Sinopharm China Biotechnology, said in an interview with 'Science & Technology Daily' that he had noticed that the virus mutates to produce new genotypes, but it is 'still within the coverage of vaccines currently undergoing international clinical studies (Phase III)', so it will not affect the effectiveness of the vaccine.

While fully advancing the research and development of vaccines, Sinopharm China Biotech has established high-grade bio-safety vaccine production workshops in two biological product research institutes in Beijing and Wuhan, with a combined production capacity of 240 million doses per year.

Liu Jingzhen said that in the next step, Sinopharm Group will steadily work on international clinical (Phase III) trials in accordance with the clinical research plan, continue to promote solidarity and cooperation with other countries and regions, and strive to market at home and abroad as soon as possible, to 'guarantee the availability of vaccines. Accessibility and affordability'.

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