Sinopharm: China Speed in COVID-19 Vaccine Development


China National Pharmaceutical Group Co., Ltd. (Sinopharm) highly values national public health security and people's health and has fulfilled its role as a Chinese central SOE since the outbreak of the COVID-19 pandemic.

The company developed a nucleic acid testing reagent and plasma therapy as well as the world's first inactivated COVID-19 vaccine, key steps in prevention and control of the epidemic.

Sinopharm sent a scientific research team to the frontline of the pandemic – Wuhan, capital of central China's Hubei province, the hardest-hit region in the country – and helped to identify the coronavirus, the culprit of the pandemic.

The company also developed a nucleic acid test kit within 48 hours after that identification, which was the first test of its kind to obtain the medical apparatus registration certificate and the first to be promoted by the National Medical Products Administration.

The test kit was a foundation of future research on the coronavirus and provided the first information about the pandemic's development.

The plasma therapy used to treat COVID-19 patients at the early stage of COVID-19 pandemic treatment is a traditional virus-fighting method using special antibodies from recovered patients' plasma. It can be traced back to more than 100 years ago and has been used to treat scarlet fever, measles, yellow fever and pertussis.

Sinopharm launched intensive study of the method after the severe acute respiratory syndrome (SARS) outbreak in 2003, from which it gained mature technical and professional capacity.

The largest blood product enterprise in China, the company has 11 kinds of blood products and ranks top in the country in number of plasma collection stations and amount of plasma collected.

With traditional verification, mature experience and extensive plasma collection, Sinopharm was the first to come up with the idea to treat COVID-19 patient by plasma therapy in China.

The company set up 50 plasma collection stations in 18 provincial regions in China and scientifically allocated medical workers for plasma production and vaccine development to ensure high speed and quality outcomes.

Regulations were made on collection, packaging, quick-freezing and storage of the plasma, and information was prepared on appropriate procedures, taboos, doses and adverse reaction during usage.

A special standard of testing of five kinds of digestive pathogens, five kinds of blood-borne pathogens and 22 respiratory pathogens was also released by the company to guarantee high-quality and safe plasma.

By May 16, 899 patients had been treated by the plasma therapy and 508 patients of 670 were improving within 48 hours of the treatment.

The plasma therapy has also been used in other countries and regions.

Sinopharm is now capable of production of 50 kinds of vaccines annually with total output exceeding 700 million doses, accounting for 80 percent of China's vaccine market.

As China's largest and the world's six-largest human vaccine production and development enterprise, Sinopharm has four national and six provincial and municipal technological centers.

In 2019, the company invested more than 1.48 billion yuan ($214 million) in scientific research, about 12.3 percent of its turnover.

With a firm foundation and rich experience in vaccine development, Sinopharm launched five vaccine development groups focused on inactivated COVID-19 vaccine and genetic engineering vaccine when the pandemic emerged in China.

It's worth mentioning that the 2019-nCoV inactivated vaccine project, part of the public security risk prevention and emergency technical equipment program initiated by the Ministry of Science and Technology, was led by Sinopharm.

The world's first inactivated COVID-19 vaccine, which was developed by a subsidiary of Sinopharm's China National Biotech Group Co Ltd (CNBG) in Wuhan, obtained clinical trial authorization on April 12 and 15 days later its production by the Beijing subsidiary was also authorized.

Phase-1 and 2 clinical trials of the vaccines were later launched in Central China's Henan province and the results were released in Beijing and Henan on Jun 16.

The results showed no serious adverse reactions after vaccination.

Moreover, people of all ages vaccinated with different doses in different procedures all showed high-titer immune response and their neutralizing antibody positive conversion rate reached 100 percent after two vaccinations.

While developing the vaccine, large-scale facilities including high-level bio-safety laboratories and workshops for development and production of the inactivated COVID-19 vaccine were also built by CNBG's institutes in Beijing and Wuhan.

Construction of the world's first inactivated COVID-19 vaccine workshop was completed in 60 days, as quickly as the makeshift Huoshenshan Hospital in Wuhan. Its annual output is expected to reach 100 million doses.

It was also a main force in fights against smallpox, polio, measles and hepatitis B as well as a pioneer in the bio-pharmaceutical industry.

Other anti-pandemic scientific research on special immune globulin, genetic engineered vaccines, humanized monoclonal antibodies and horse antiserum are also in progress and will play a role in the fight against the pandemic.

The special immune globulin extracted from the convalescence plasma has particularly high purity and potency in coronavirus neutralizing antibodies and is now the most promising cure for the pandemic.

Three preliminary experiments of the common plasma were done to confirm validity of the production method of the COVID-19 immune globulin.

So far, three batches of such products have passed inspection by the National Institutes for Food and Drug Control and become national strategic reserve emergency drugs.

In early April, the immune globulin therapy was promoted to be used in treatment of the pandemic worldwide.



(Executive editor: Wang Ruoting)


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