The approval comes with conditions but regulator is confident the vaccine is safe and effective

National Health Commission says the shot is a ‘public good’ and will be provided to national inoculation programme

The Covid-19 vaccine developed by the China National Pharmaceutical Group (Sinopharm) has been approved for market, with conditions, and will be provided free to the national inoculation programme, Chinese officials said on Thursday.

The vaccine, developed by Sinopharm subsidiary the Beijing Institute of Biological Products, has already been provided to high risk groups

in China under an emergency use authorisation.

“Yesterday, to be exact, last night, we have approved the vaccine by the Beijing Institute of Biological Products under China National Pharmaceutical Group in accordance with the law,” said Chen Shifei, deputy head of the National Medical Products Administration.

“After assessment the gains of the vaccine outweighs the risks … The vaccine will still continue with Phase 3 trials.”

Chen said the administration had reviewed the relevant data and conducted a series of site inspections to ensure production quality for the vaccine was up to standard. The trial inspection was done remotely but relied mostly on the investigators, he said.

Zeng Yixin, deputy director of the National Health Commission, said the price of the vaccine would be set according to cost, which would come down as production ramped up, but it would be provided to the public for free.

“The vaccine is a public good and the price might vary, but the big premise is it will be provided to the public for free.”

The vaccine, which went through a rolling application, was shown to be safe and 79.34 per cent effective against Covid-19, according to an interim analysis announced by the company on Wednesday.

China’s drug regulator requires Covid-19 vaccines to be at least 50 per cent effective, and preferably over 70 per cent, with immunity lasting more than six months, for approval to be granted.

The Sinopharm vaccine was one of three approved for emergency use in July, with more than 1.5 million people vaccinated so far, according to Zeng.

The vaccine, which uses an inactivated technology involving a killed Sars-CoV-2 virus, was safe with similar rates of adverse events to other inactivated vaccines, he said.

“Mild fever occurred in less than 0.1 per cent and serious allergy [reaction] occurred in about two per million.”