BEVERLY HILLS, December 31, (THEWILL) – China has approved the conditional use of its first coronavirus vaccine, developed by state-owned pharmaceutical company Sinopharm.
The approval was announced by the Joint Prevention and Control Mechanism of the State Council on Thursday.
Deputy Commissioner of China’s National Medical Products Administration, Chen Shifei, said the regulator had agreed to the public release of a vaccine developed by 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. It has fully met the requirements for conditional launch”, Chen said
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.
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 added.
But he stopped short of providing detailed data on the trials, saying that the company would publish them at “a later date”.
However, a Shanghai-based pharmaceutical executive director remained sceptical; “we have no idea how the trials were conducted. 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.
“I don’t expect drug regulators in Bahrain and the United Arab Emirates to hold the same bar as US FDA.”
State-owned Sinopharm is among at least five Chinese companies that have been approved to carry out clinical trials for potential vaccines.
China has 15 coronavirus vaccines in clinical trials, including five that have entered phase -3 clinical trials, a state council official said last week.
This is the first time a Chinese company released late-stage trial efficacy data for a vaccine candidate.
Sinopharm’s vaccine efficacy rate is behind those reported by U.S. companies Pfizer, of 95 per cent, and Moderna, of 94 per cent.
China aims to vaccinate at least 50 million people before the start of the Lunar New Year holiday, in mid-February, in order to prevent the disease from spreading as hundreds of millions of people are expected to travel home for the holidays.
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