Shanghai, China, Dec 31 (efe-epa).- China has approved for general public distribution a homegrown coronavirus vaccine developed by state-owned pharma giant Sinopharm, moving a step closer towards a massive inoculation campaign, officials said on Thursday.
The approval came after the developer on Wednesday said it had filed for conditional marketing authorization from the National Medical Products Administration (NMPA) after reporting that the vaccine efficacy was 79.34 percent.
A unit of the China National Biotec Group (CNBG), a Sinopharm affiliate, and its subsidiary, Beijing Institute of Biological Products, have developed the vaccine.
The announcement paves the way for the vaccine’s large-scale countrywide and global rollout program.
NMPA deputy commissioner Chen Shifei told reporters that the vaccine was approved overnight after experts of the regulator comprehensively reviewed the information and data on safety, efficacy, and quality control of the vaccine.
“After strict verification examinations, according to local procedures, we arrived at the conclusion that its known and potential benefits outweigh its known and potential risks,” Chen said.
The vaccine, he said, “has reached the preset standards for conditional market approval.”
The regulator has asked the developer to continuously update the vaccine’s instructions and labels and report to the agency any findings that might emerge.
Chen said vaccines needed urgently for major public health emergencies could be approved conditionally for registration according to drug administration laws.
The developer on Wednesday said it had done an interim analysis of Phase 3 clinical trials in China.
“After a two-dose inoculation procedure, the vaccine receivers produced high-tier antibodies, and the seroconversion rate of neutralizing antibodies reached 99.52 percent,” it said.
But Sinopharm did not mention any possible side effects of its vaccine.
The Chinese health authorities have earlier maintained that there were no serious adverse effects during the trials of different vaccines developed in the country.
The developer also did not reveal the number of inoculated participants who contracted the virus or reported any side effects for conclusive proof of its effectiveness.
CNBG President Wu Yonglin said such data would be published in Chinese and also foreign medical journals later.
Wu said the trial results “exceeded the existent clinical standards, the safety standard performance exceeded that of WHO and also met China’s standards.”
Sinopharm is one of the five Chinese developers of vaccines for the coronavirus that has killed more than 1.8 million people.
China gave conditional emergency use approval in June to other vaccine candidates developed in the country.
Zeng Yixin, a National Health Commission official, said Thursday more than one and a half million doses of the vaccines were administered between June and November.
On Dec.15, China began a more ambitious vaccination campaign for risk groups. Since then, another three million doses have been administered. EFE-EPA