BEIJING • A leading Chinese vaccine developer has applied for authorisation to bring its Covid-19 vaccine to the market, seeking to get a jump on Western rivals as the race for a working shot against the pandemic enters the final stretch.
China National Biotec Group (CNBG) has submitted an application to Chinese regulators, reported state media Xinhua Finance yesterday, citing parent company Sinopharm's vice-general manager Shi Shengyi.
The application likely includes data from the company's phase 3 human testing conducted in the Middle East and South America.
Stocks related to Sinopharm Group, including its Hong Kong unit, surged yesterday after the news.
A CNBG spokesman said she had no further information when contacted by Bloomberg. Calls to Sinopharm Group went unanswered.
With the application, CNBG will likely become the first developer outside of Russia to see its shots made available for general public use, underscoring China's determination to be a major player in supplying inoculations to countries around the world.
Western drugmakers such as Pfizer are only at the stage of seeking authorisation for emergency use of their shots, a status China granted to its developers months ago. The race has taken on vital importance as countries look to more definitively reopen their economies and stem a pandemic that has sickened over 59 million.
Working vaccines are seen as the best hope as a fresh wave of infections is forcing nations to reintroduce lockdowns and other restrictions.
A state-owned drugmaker that has a dominant share of China's vaccine market, CNBG in April was among the world's first to push experimental shots to the crucial final stage of human testing.
The company's research institutes developed two shots using an inactivated version of the virus to stimulate immune response, an approach widely adopted by many of the existing vaccines used around the world.
Despite the fact that the vaccines have not yet received regulatory approval for widespread use, they have already been given to hundreds of thousands of people in China under an emergency-use programme. That has raised concern among scientists of potential risks in using shots whose safety has yet to be thoroughly studied.
CNBG has said that its phase 3 trials - involving more than 50,000 people in countries from Argentina to Egypt - have been progressing smoothly, and it has not received any reports of serious adverse events.
Safety has become a major concern as drugmakers compress the vaccine development process from years to a matter of months.
AstraZeneca and Johnson & Johnson paused their trials after a participant developed an unexplained illness. Another Chinese front runner, Sinovac Biotech, also saw its trial briefly halted in Brazil after a participant died. All three trials resumed after investigators found no evidence that the events were caused by the vaccines.
Pfizer said this month that the shot it co-developed with BioNTech has a protection rate of more than 90 per cent. Russia later declared that its Sputnik V vaccine has achieved a protection rate of 92 per cent. CNBG has not released any public data on the efficacy of its shots.
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