Beijing: China has granted conditional approval to the country’s first homegrown COVID-19 vaccine developed by state-owned pharmaceutical giant Sinopharm, an official announcement said on Thursday.
The approval comes a day after Sinopharm said its vaccine showed 79.34 per cent efficacy and a 99.52 per cent antibody-positive conversion rate in the interim results of the Phase III clinical trials.
“The inactivated vaccine, developed by Beijing Biological Products Institute under Sinopharm’s subsidiary China National Biotec Group (CNBG), got official authorisation from China’s National Medical Products Administration on Wednesday,” Chen Shifei, deputy head of the National Medical Products Administration, was quoted as saying by the state-run Global Times.
The Sinopharm’s vaccine results are better than the 50 per cent standard of the World Health Organization (WHO) and Chinese authorities, the report said, adding that the vaccine also showed a good safety level.
China’s National Medical Products Administration’s drug registration bureau said earlier that a total of 11 Chinese vaccine candidates are in different stages of testing at home and abroad.
Beijing Biological Products Institute Co, a Sinopharm subsidiary, said in a statement on Wednesday that interim results show the Sinopharm vaccine is safe and people who received two doses produced high-level antibodies.
The announcement of China’s approval for one of its vaccines came after the US authorised Pfizer and Moderna jabs.
Britain has approved the Oxford-AstraZeneca vaccine for use in the UK, with the first doses due to be given on Monday.
Russia too has approved its vaccine Sputnik-V.
Both Moderna’s and the Pfizer-BioNTech vaccine have shown similar efficacy levels of nearly 95 per cent, which the official media here said was beyond predictions and drove up the public’s expectation for Chinese inactivated vaccines.
The CNBG chairman Yang Xiaoming told the Global Times earlier a vaccine has to undergo strict review by each country’s national drug administration before being authorised for public use. All data and processes are reviewed by professional third-party committees,
Yang was inoculated with a CNBG vaccine in March along with hundreds of his colleagues, the report said. He said they had tested the level of antibodies six months after vaccination and the results were good.
Yang noted that data on safety and efficacy collected so far in the Phase III clinical trials is better than expected.
Reported side effects of the vaccines are also milder than expected, Yang said.
The side effects of CNBG’s inactivated vaccines include aches or redness at the injection site, fever, muscular soreness, sickness and headache, the Global Times report said.
To form an immunology barrier, it requires at least 700 million Chinese residents to be vaccinated, which means at least 1.4 billion doses are needed, Yang said.
Normally there would only be 500-700 million doses of vaccines available on the Chinese market every year, Yang said, adding that it would be a big challenge for China to conduct mass vaccination in such a short time.
He said CNBG’s production capacity of COVID-19 inactivated vaccines has reached 120 million doses by the end of the year and it will expand to one billion doses per year in 2021.
China has established a complete cold-chain industry for vaccine delivery, he said.
Sinopharm’s inactivated vaccines have been administered to nearly one million people for emergency use in China and no serious adverse reactions have been reported, the paper said.
About 70,000 volunteers have participated in the phase-III clinical trials in more than 10 countries, it said.
Wuhan, the central Chinese city where the coronavirus emerged a year ago before it became a pandemic, has started the emergency use of COVID-19 vaccine candidates on certain key groups of people from December 19.
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 their residents.
China’s National Health Commission said that the Chinese mainland on Wednesday reported 25 newly confirmed COVID-19 cases.
The total number of confirmed COVID-19 cases on the mainland reached 87,052 by Wednesday, including 368 patients still receiving treatment, it said.
China has already joined the COVAX, an international vaccine alliance.
According to the WHO, nine candidate vaccines, including two from China, are currently being evaluated for inclusion in the COVAX facility.
The COVAX is co-led by Gavi, an international vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.