China approved a coronavirus vaccine produced by Sinopharm on Thursday, a day after the state-owned drugmaker announced the shot was 79.3 percent successful, paving the way for millions of Chinese vaccine doses to reach the global market.
A two-shot vaccination from the China National Biotec Group (CNBG), a subsidiary of Sinopharm, was granted the green light by authorities, an official with China's National Medical Products Administration said at a media conference.
FILE PHOTO: A signage of Sinopharm is seen at the 2020 China International Fair for Trade in Services (CIFTIS), following the COVID-19 outbreak, in Beijing, China September 5, 2020.
For Beijing, the vaccine is vital. It is the first approved vaccine for general use in China as it strives to keep the epidemic controlled and deflect scrutiny of its treatment of the virus that erupted in Wuhan at the end of 2019.
But questions were posed by the lack of information released by regulators and Sinopharm.
The CNBG announced data based on preliminary analyses from Phase 3 trials on Wednesday. Its unit did not include main details like the sample size or the number of pathogens or side effects evaluated in the trial in its short statement on the Beijing Institute of Biological Products website.
Experts Alarmed Over Sinopharm's Efficacy
MHRA's decision was debated by some physicists, asking how much defense a single shot provides. Xi Chen, an assistant public health professor at Yale University, found the vaccine's missing details.
According to the company's chairman, the shot is one of two produced by Sinopharm. Their vaccinations have already been used on approximately 1 million Chinese people as of November in an emergency use program for high-risk populations.
Sinopharm could have a far greater size trial than Oxford-AstraZeneca, Chen said. Although the Chinese government could be more optimistic due to the far greater number of recipients of Sinopharm, Chen said it is necessary to gain market interest by releasing relevant clinical trial results.
According to CNBG President Wu Yonglin, comprehensive results will be issued later and reported in science journals in China and overseas. The company said the dosage protocol proved "safe" and that a high degree of antibodies against the virus was developed by those who obtained it.
How Did The Emergency Use Authorization Go?
Chinese health authorities said Thursday that Chinese people received a record of more than 4.5 million doses of the coronavirus vaccine. Zeng Yixin, vice minister of China's National Health Commission, said less than 0.1 percent of receivers experienced a fever, and 0.2 percent suffered allergic reactions.
A significant emergency vaccine campaign is underway as coronavirus cases increase worldwide, with medication manufacturers and policymakers scrambling to have their vaccinations authorized. On Wednesday, the British government said that its regulator had licensed a vaccine produced by the University of Oxford and AstraZeneca.
The Sinopharm vaccine seems to be less successful than those produced by Moderna with a 94 percent efficacy rate and Pfizer-BioNTech with a 95 percent efficacy rate. The Oxford-AstraZeneca vaccine was 62 percent successful for those offered two maximum doses, according to interim reports. For a subgroup that obtained a half dose followed by a full amount, the vaccine was 90 percent successful. But British regulators said they remained skeptical about the vaccine's half-dose treatment effects.
United Arab Emirates officials claimed Sinopharm's efficacy rate is also less than the 86 percent rate recorded, following clinical trials performed there. Sinopharm has not released facts responsible for the difference.
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