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Chnia: COVID-19 Vaccines – Regulatory Actions/Deployment
China grants conditional market approval for Sinopharm CNBG’s COVID-19 Vaccine
The inactivated COVID-19 vaccine developed by Beijing Institute of Biological Products of Sinopharm CNBG has been granted conditional registration by the NMPA of China, Chinese equivalent of FDA, according to a press conference of the State Council Joint Prevention and Control Mechanism on December 31, 2020.
Over 60,000 volunteers of 125 nationalities have participated in the Phase III clinical trial of Sinopharm CNBG in countries outside China including UAE and Bahrain. The vaccine’s efficacy rate based on interim analysis is higher than the target set at the beginning, and its safety and effectiveness performances also exceed the standard level of both WHO for market approval and the Chinese regulatory authority for conditional market approval, which entitles the vaccine a general public use in China.
Aside from China, Sinopharm CNBG’s COVID-19 vaccine was announced to be officially registered in UAE and Bahrain on December 9 and 12 respectively, based on the results of Phase III clinical trials indicating 86% efficacy rate, 99 % seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of COVID-19.
Because the standards of diagnosis of infection cases and review process of Phase III clinical trial vary in different countries, the 86% efficacy rate announced by UAE and 79.34% by China are both real and valid.
A vaccine against COVID-19 should be evaluated comprehensively in various aspects such as safety, effectiveness, accessibility and affordability. Safety is undoubtedly the premise, on which the performance in effectiveness also matters to a large extent. Others including manufacturing capacity, storage and logistics conditions, targeted population should also be considered.
Generally speaking, Sinopharm CNBG’s COVID-19 vaccine has shown comprehensive strengths. A large sample of injection and data prove its safety and effectiveness. Besides, the vaccine doesn’t require freezing temperatures for storage, making transport and distribution much easier for most of the countries in the world. Its capacity is also large enough for massive inoculation.
The Chinese approved COVID-19 vaccine adds to the world’s faith in beating the pandemic. As defined by the Chinese government to be a global public good, Sinopharm CNBG COVID-19 vaccine will make its own contribution to the global fight against the coronavirus disease in the future.
National Health Commission of the People’s Republic of China [to 2 Jan 2021]
Emergency use of COVID-19 vaccines expands to larger scale
Updated: 2020-12-31 | Xinhua
— The emergency use of vaccine mainly targets groups of people with higher risks of infection. They include medical workers, customs officers, primary-level epidemic prevention workers, overseas returnees and people working in cross-border cold-chain logistics and isolation centers.
— Experts remind people that they should still take protective measures after receiving the vaccination.
BEIJING — With the recent increase of sporadic COVID-19 cases and progress in the development and manufacture of vaccines, China’s emergency use of vaccines has expanded to a larger scale.
Inoculation of key groups has already started in Shanghai, Guangdong, Jiangxi, Shandong and the city of Wuhan in central China’s Hubei province. Many other provinces and municipalities have also drafted a schedule for COVID-19 vaccination in the coming months.
China granted emergency use of COVID-19 vaccines in June.
The emergency use of vaccine mainly targets groups of people with higher risks of infection. They include medical workers, customs officers, primary-level epidemic prevention workers, overseas returnees and people working in cross-border cold-chain logistics and isolation centers.
The southern Chinese city of Shenzhen began on Monday inoculating people who have urgent plans to travel overseas…
…In Guangdong Province, over 180,000 people had been given COVID-19 vaccines as of Dec 22, according to the provincial government. No serious side effects have been reported among the vaccine receivers, said the information office of the provincial government of Guangdong.
Wuhan, a city previously hit hard by the novel coronavirus, also started the emergency use of COVID-19 vaccines, with vaccinations available at 48 designated clinics in 15 districts starting from Dec 24…
National Medical Products Administration [to 2 Jan 2021]
Chinese COVID-19 vaccines free to all its citizens: official
China will provide COVID-19 vaccines free of charge to all its citizens, said Zeng Yixin, deputy head of the National Health Commission, at a press conference on Dec 31.
China grants conditional approval for first COVID vaccine
China announced it has granted conditional market approval for its first COVID-19 vaccine during a news conference on Dec 31.
The vaccine, developed by State-owned Sinopharm, was approved by China’s top drug regulator on Wednesday night, said Chen Shifei, deputy head of the National Medical Products Administration.
The vaccine is generally safe and has a 79.34 percent efficacy rate according to clinical results released by the company on Wednesday. Strict supervision will continue to be carried out over the vaccine after its approval to ensure its safety and quality, Chen said.
A total of 14 COVID-19 vaccines developed by China are now under clinical trials, including five under phase-3 trials.
Before the official approval of the vaccine, the vaccine and several other COVID-19 vaccines in phase-3 clinical trials have already been put into emergency use in China over the past few months. Millions of doses have been used for priority groups such as frontline medical workers and people going overseas to work, and the safety and efficacy of the vaccines have been proved, said Zeng Yixin, vice-minister in charge of the National Health Commission.
Sinopharm’s vaccine shows protection rate of over 79%
Sinopharm’s COVID-19 vaccine can induce neutralizing antibody in 99.52 percent of recipients, and has a 79.34 percent efficacy rate, according to midterm clinical results released on Dec 30.
The inactivated vaccine candidate created by Sinopharm’s Beijing Biological Products Institute is generally safe, and a high level of neutralizing antibodies can be detected in 99.52 percent of the recipients after two doses, the company said in a statement on Wednesday.
The vaccine is also 79.34 percent effective at preventing the symptoms of COVID-19, meaning it has met the requirement by the World Health Organization and the National Medical Products Administration. Now, the company has officially submitted its request for market approval to the administration, it said.
China’s Wuhan begins emergency-use COVID-19 vaccination
WUHAN — The city of Wuhan in central China has started the emergency use of COVID-19 vaccine candidates on certain key groups of people, the municipal government said on Dec 28.
The vaccination, available at 48 designated clinics in 15 districts, began on Dec 24, targeting some key groups of people aged between 18 and 59, said He Zhenyu, deputy director of the center for disease control and prevention in Wuhan, capital of Hubei province.
Those receiving the vaccine need to take two shots with an interval of four weeks, said He at a press briefing…