Sinopharm vaccine is the first one approved for general use in China – Xinhua
China on Thursday announced its first approval of a domestically engineered Covid-19 vaccine for general use, a day after its developer said it was 79.34 percent effective.
The two-dose vaccine developed by a unit of state-owned Sinopharm has already been used to vaccinate people in China under an emergency use programme launched in July. It has also been approved in the United Arab Emirates and Bahrain.
Sinopharm is one of at least five Chinese developers that are rushing to create Covid-19 vaccines and help show China as the world’s saviour, rather than the source of the pandemic.
Chinese President Xi Jinping has pledged to make its vaccines a global public good, and give priority to Southeast Asian nations, including Indonesia, Malaysia, the Philippines, Thailand and Vietnam.
The Sinopharm vaccine can be stored at 2 to 8 degrees Celsius, or fridge temperature, making it easier to handle than the Pfizer or Moderna shots, which need to be stored in much colder temperatures.
But many countries will be wary of using Chinese vaccines given past major scandals involving expired or poor-quality products.
Sinopharm’s subsidiary, the Beijing Institute of Biological Products, has yet to publish detailed results of its trials to boost credibility in the vaccine, including how many people were vaccinated, the size of the control group and how long after the injection the efficacy rate was reached.
Technically, China has granted conditional approval for the vaccine, which means that research is still ongoing and the company must submit follow-up data and reports of any adverse effects, Chen Shifei, deputy commissioner of the National Medical Products Administration, told a news conference.
The approval of the Sinopharm vaccine came shortly after China launched a programme to vaccinate 50 million people before the Lunar New Year holiday in February.
On Thursday, China’s National Health Commission said 3 million people had been vaccinated since Dec. 15, although it didn’t say which vaccines they had received.
China has already been giving vaccines that are still in their testing stages to frontline healthcare workers and others since July – an approach that runs counter to that of many Western countries.
China has allowed the emergency use of three Covid vaccine candidates developed by state-owned Sinopharm, and company Sinovac Biotech. Another experimental vaccine was approved for use by the Chinese military in June.
Sinopharm started developing a vaccine in January, when the coronavirus outbreak was unfurling in the Chinese city of Wuhan.
In June, when more than 100 potential vaccines against Covid-19 were in development around the world, researchers announced that the Sinopharm candidate had shown promise in trials in monkeys, and a human trial with more than 1,000 participants was under way.
In July, phase 3 clinical trials began in the United Arab Emirates, involving 31,000 volunteers of 125 nationalities. A month later, Morocco and Peru began phase 3 trials.
In September, the UAE granted emergency approval for it to be used on health care workers.
In November, Sinopharm announced that nearly one million people had taken one of its experimental vaccines. It said that no serious adverse reactions had been reported, and that none of the construction workers, diplomats or students who went abroad after receiving it had been infected.
On December 9, the United Arab Emirates gave a boost to China’s vaccine ambitions, issuing the first overseas government approval of a Chinese vaccine.
The UAE said that analysis of trials had shown the Sinopharm vaccine candidate to be 86 percent effective. That was higher than the 79.34 percent efficacy rate announced by the company on Wednesday. A spokeswoman declined to explain the discrepancy and said detailed results would be released later, without giving a timeline.
On December 13, the vaccine was approved for use in Bahrain, and it is slated for use next in Morocco.