China Approves First Domestic COVID-19 Vaccine

Sinopharm’s inactivated vaccine is China’s first domestic COVID-19 vaccine

On the last day of 2020, the Joint Prevention and Control Mechanism of State Council announced that China National Pharmaceutical Group’s (AKA Sinopharm) inactivated COVID-19 vaccine obtained conditional marketing approval, a fast-tracked authorization process for treatments that fulfill unmet medical needs. Under Sinopharm, this approved vaccine was developed by China National Biotec Group’s (CNBG) Beijing Institute of Biological Products, while its Wuhan Institute is also working on another inactivated vaccine. The National Medical Products Administration (NMPA) explained that the existing and potential benefits of the vaccine outweigh the related risks, and meets regulatory requirements for conditional marketing. After launching, NMPA will continuously monitor the company in its completion of its phase III clinical trials and post-marketing research.

Sinopharm unveiled the interim results of its phase III clinical trials for the inactivated vaccine on December 30. The data showed that participants who received two shots generated a high test score of antibodies, with a 99.52% positive conversion rate of neutralizing antibodies and a 79.34% protection rate against novel coronavirus related diseases. In other words, 79.34% of people who received the vaccination will not be infected by the coronavirus, 99.52% of them will be asymptomatic if infected, and 100% will not turn into severe or critical cases.

Nevertheless, the enterprise did not disclose details such as testing regions, and the number and ages of the participants. For reference, Sinopharm Chairman Liu Jingzhen indicated that the group was conducting the last stage of international clinical testing in the United Arab Emirates (UAE), Bahrain, Egypt, Jordan, Peru, Argentina, and other four foreign countries, enrolling nearly 60,000 participants by November 2020. In the meantime, Sinopharm’s inactivated vaccines have taken part in the country’s emergency use program since July 2020. By the end of last November, the cumulated vaccination volume exceeded 1.5m doses, among which, about 60,000 people have gone to high-risk, overseas areas for work without any severe cases of infection reported, according to Deputy Director of the National Health Commission (NHC), Zeng Yixin.

China considers a three-phase vaccination plan following the approval

In general, it is believed that in order to attain herd immunity levels against a virus, the received vaccination rate of the population should be between 60% to 70%. Zeng Yixin stated that the country plans to reach the point through COVID-19 vaccines, which will be free for the Chinese public.

China has already begun vaccinating high-risk and key population groups from December 15, including medical, customs inspection and quarantine personnel, with over 3m doses of Sinopharm’s inactivated vaccine injected. Among them, the incidence of mild fever was less than 0.1%, and the incidence of more severe adverse reactions like anaphylaxis was about two in a million. These statistics are similar to other kinds of inactivated vaccines for regular use. Based on this and the official permit for Sinopharm’s vaccine, as part of the second phase, the country will gradually begin vaccinating the elderly, and immunocompromised population. Afterward, the rest of the population would then have the option to be vaccinated.

On December 31, 2020, Beijing Municipal Government first released its vaccination timetable and the first batch of nine key groups aged between 18 and 59 years old who will receive two shots for per person before the 2021 Spring Festival in mid-February. The age limits are because Sinopharm has yet to release its overall phase III testing results. The interval between two injections is from two to four weeks, and the nine groups include medical personnel, customs inspection and quarantine personnel, people who are going abroad for work or study, and others. After the Spring Festival, the vaccination arrangement will expand to the rest of the population. On January 1 and 2, 2021, the capital city injected 73,537 doses of Sinopharm’s inactivated vaccine in 220 plots, without any severe or adverse effects.

As for the production capacity to secure an adequate vaccine supply, CNBG finished the construction of its Beijing and Wuhan plants in 2020 and is now mass producing the vaccines in the Beijing plant. With the output of 100m doses by the end of 2020, the company expects that the total annual output will increase to over 1bn doses in 2021, allowing 500m people to receive vaccination.

Chinese vaccine developers are constructing and expanding production capacity of COVID-19 vaccines for public use

By 2020, 14 Chinese COVID-19 vaccines launched clinical trials with five in the final stage, including Sinopharm’s two inactivated vaccines, Beijing Sinovac Biotech’s [SVA:US] inactivated vaccine, CanSino Biologics’ [6185:HK] adenovirus vector vaccine, and Chongqing Zhifei Biological Products’ [300122:CH] recombinant protein vaccine. According to the R&D progress of their COVID-19 vaccines, 18 Chinese companies have been constructing their vaccine production plants. By 2020, CNBG’s Beijing and Wuhan Institute and Sinovac Biotech completed the construction of their facilities and passed regulatory inspections.

Sinovac Biotech also participated in China’s COVID-19 vaccine emergency use program. Meanwhile, the firm carried out phase III clinical trials of its inactivated vaccine in Brazil, Indonesia, and Turkey. Although the company has not published its testing results formally, in late December of 2020, Brazilian researchers announced the protection rate of Sinovac’s vaccine was over 50% and Turkish officials claimed the rate was 91.25%. Consequently, Sinovac delivered the first batch of 3m doses of its vaccine to Turkey on December 30, 2020, while Indonesia and Ukraine also inked procurement agreements with the firm. The current production capacity of Sinovac is 300m doses, which is expected to raise to 600m in 2021, and the firm previously said it could provide 100m doses by the year-end of 2020.

CanSino Biologics is developing its vaccine (trade name: ConvideciaTM) in collaboration with the Academy of Military Medical Sciences (AMMS) and has enrolled over 20,000 volunteers for its international phase-III clinical trials by last December. It is expected the total number will be 40,000. Different from inactivated vaccines, the company’s vaccine only needs one shot. The firm teamed up with Shanghai Pharmaceuticals [2607:HK] to ensure the supply of vaccines in August 2020, and it was reported that its annual output would be 300m doses. Later, CanSino’s CEO disclosed last November that the firm’s vaccine had been injected into 40,000 to 50,000 people after the Chinese military approved it for emergency use.

As for a recombinant protein vaccine, Chongqing Zhifei’s subsidiary is partnering with the Institute of Microbiology of the Chinese Academy of Sciences (CAS), and began international phase-III trials in November. Similarly, based on the company’s current production capacity, it could also reach an annual output of 300m doses to meet the need of 150m people, once approved.

Currently, the launch of the first domestic vaccine will be largely conducive to China’s prevention and control of the pandemic in winter, which is a season where the population if more prone to coronavirus infection. Moreover, it will protect people with higher risks for infection, such as cold chain logistics workers and customs frontier personnel, as imported food products delivered via cold chain and people entering the country are the main sources of the coronavirus in China now. Although people are still subject to prevention and control requirements for COVID-19, such as wearing masks, after taking vaccination, these approved and ongoing domestic vaccines could effectively help with the control of the coronavirus spread in China.

In addition, as the Chinese government has promised to offer COVID-19 vaccines to other countries, especially developing countries and regions, these Chinese vaccine developers are also accepting vaccine orders from foreign countries, facilitating them to combat the pandemic. Industrial Securities [601377:CH] cited data that by 2021, the global cumulative capacity would be over 9bn doses, with China expected to exceed 2bn doses. By November 2020, 16 countries and regions had ordered 500m vaccines from China.

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