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A staff member checks the packaging quality of COVID-19 inactivated vaccine products at a packaging plant of Beijing Institute of Biological Products Co., Ltd. in Beijing, capital of China, on Dec.25, 2020. Photo : Xinhua
China announced on Thursday that it granted attached market approval with conditions for its first COVID-19 home vaccine, which was developed by Sinopharm, marking a monumental step in the battle against the pandemic that has killed 1.79 million across. the world.
The inactivated vaccine, developed by the Beijing Institute of Biological Products under Sinopharm’s China National Biotec Group (CNBG) subsidiary, obtained official authorization from the China National Medical Products Administration on Wednesday, said Chen Shifei, deputy director of the National Administration. of Medical Products, at Thursday’s press conference.
The move came a day after the institute announced that the vaccine showed an efficacy of 79.34 percent and a positive antibody conversion rate of 99.52 percent, based on interim results of phase III clinical trials. .
The results are better than the 50 percent standard of the World Health Organization (WHO) and Chinese authorities, according to the institute. The vaccine also showed a good level of safety, its producers said.
A vaccine must undergo strict review by each country’s national drug administration before being licensed for public use. All data and processes are reviewed by third-party professional committees, CNBG President Yang Xiaoming told the Global Times in a recent exclusive interview.
Yang was inoculated with a CNBG vaccine in March with hundreds of his colleagues. He said they had tested the antibody level six months after vaccination and the results were good.
Yang noted that the safety and efficacy data collected so far in phase III clinical trials is better than expected.
The reported side effects of the vaccines are also milder than expected, Yang said. Side effects of inactivated CNBG vaccines include soreness or redness at the injection site, fever, muscle pain, nausea, and headache.
A Sinopharm representative told the Global Times on Wednesday that the interim results are based primarily on data from trials conducted in the United Arab Emirates, the vaccine’s largest evidence base. The Chinese regulator uses a very rigorous standard, stronger even than international criteria, when reviewing the number of confirmed infected cases in double-blind, placebo-controlled trials to understand the efficacy of the vaccine.
The Beijing institute’s vaccine was approved in the United Arab Emirates and Bahrain earlier this month.
The two inactivated Sinopharm vaccines have been administered to nearly 1 million people for emergency use and no serious adverse reactions have been reported. Approximately 70,000 volunteers have participated in phase III clinical trials in more than 10 countries.
So far, at least 10 provinces in China, including East China’s Jiangsu Province and South China’s Guangdong Province, have officially announced a vaccination plan for local residents.
To form an immune barrier, at least 700 million Chinese residents are required to be vaccinated, which means at least 1.4 billion doses, Yang said.
Normally, there would only be 500-700 million doses of vaccines available on the Chinese market each year, Yang said, noting that it would be a great challenge for China to carry out mass vaccination in such a short time.
According to Yang, CNBG’s COVID-19 inactivated vaccine production capacity has reached 120 million doses by the end of the year and will expand to 1 billion doses per year in 2021.
Yang noted that China has established a complete cold chain industry for vaccine delivery. The only potential problem may lie in the imbalance between different areas, such as the developed coastal areas and the central and western areas that are comparatively less developed.
Tao Lina, a vaccine expert in Shanghai, said the approval shows that China has created a “miracle” by creating a vaccine in one year.
Pfizer and Moderna have announced 95 percent efficacy for their mRNA vaccines, which went beyond predictions and raised public expectations for Chinese inactivated vaccines.
Tao noted that despite high efficacy, US mRNA vaccines have shown more side effects and cases of acute allergy. The mRNA vaccines also have more stringent transport requirements.
Tao suggested that inactivated and mRNA vaccines can help humans resist the new coronavirus. But both are early stage products and more improved ones are expected, which will offer a better balance between efficiency, safety and transport requirements.
