China has given conditional approval for the first general use of a locally made Covid-19 vaccine, paving the way for distribution of the jab at home and abroad.
Chen Shifei, deputy commissioner of China’s National Medical Products Administration, said the regulator had agreed to the public release of a vaccine developed by the Sinopharm, a state-owned pharmaceutical company. The approval was announced a day after Sinopharm said the drug had achieved a 79 per cent efficacy rate in late stage clinical trials.
“The known and potential benefits of the (vaccine) outweigh the known and potential risks,” said Mr Chen. “It has fully met the requirements for conditional launch.”
Medical experts, however, have warned that a lack of independent oversight of clinical data and loopholes in test design have undermined the vaccine’s effectiveness. The United Arab Emirates and Bahrain, the only two countries to have already approved the vaccine for use, reported 86 per cent efficacy in trials this month.
“We have no idea how the trials were conducted,” said the director of a big Shanghai-based pharmaceutical company. “There is no information on the age, gender and health condition of test participants and these data points are crucial to a good understanding of whether the vaccine works.”
Sinopharm conducted most of the phase 3 trials of the vaccine abroad because China has largely suppressed coronavirus at home.
Wu Yonglin, the company’s president, said the trial results exceeded the World Health Organization’s requirements. “The [vaccine] could create effective protection for a large group of people,” he said. But he stopped short of providing detailed data on the trials, saying that the company would publish them at “a later date”.
The Shanghai-based pharmaceutical executive remained sceptical. “I don’t expect drug regulators in Bahrain and the United Arab Emirates to hold the same bar as US FDA,” the person said.
Many developing countries have struggled to procure vaccines developed in Europe and the US, which typically have efficacy rates of more than 90 per cent, and are expected to agree deals with Chinese companies. Chaudhry Fawad Hussain, Pakistan’s science and technology minister, wrote on Twitter on Wednesday that the country had agreed to purchase 1.2m doses of Sinopharm’s vaccine.
Mr Chen said Beijing did not send any representatives to foreign countries to assess the quality of the trials.
“We rely on [foreign] research institutes to take the responsibility to ensure the completeness of data,” he said, adding that his agency had conducted a virtual assessment.
Some in China, including health professionals, intend to take a cautious approach to being vaccinated, even though Beijing has pledged to offer shots for free.
“I am not going to get the vaccine over safety concerns,” said a doctor at a leading hospital in the eastern Shandong province. “It is still in clinical trials.”
Sinopharm is developing a second Covid-19 vaccine while Sinovac and CanSino Biologics, two other Chinese pharmaceutical companies, are also working to manufacture a jab.
Additional reporting by Xinning Liu in Beijing and Farhan Bokhari in Islamabad