A major Chinese vaccine developer has applied for authorization to bring its Covid-19 vaccine to market, seeking to get ahead of its Western rivals as the race for a working shot against the pandemic enters the home stretch.
China National Biotec Group Co. has submitted a request to Chinese regulators, state media Xinhua Finance reported on Wednesday, citing the deputy general manager of parent company Sinopharm, Shi Shengyi. The app will likely include data from the company’s Phase III human trials conducted in the Middle East and South America.
Shares related to Sinopharm Group, including its Hong Kong unit, rose on Wednesday after the news.
A CNBG spokeswoman said she had no further information when contacted by Bloomberg. Calls to the Sinopharm Group went unanswered.
With the app, CNBG will likely become the first developer outside of Russia to see its shots available for general public use, underscoring China’s determination to be a major player in supplying vaccines to countries around the world. Western drug makers such as Pfizer Inc. are only in the stage of requesting authorization for the emergency use of their injections, a status that China granted its developers months ago.
The race has become vitally important as countries seek to more definitively reopen their economies and stop a pandemic that has sickened more than 59 million. Vaccines that work are considered the best hope, as a new wave of infections is forcing nations to reintroduce lockdowns and other restrictions.
CNBG, a state-owned pharmaceutical company with a dominant share of China’s vaccine market, was among the first in the world in April to take experimental injections to the crucial final stage of human testing. The company’s research institutes developed two injections using an inactivated version of the virus to stimulate the immune response, an approach widely adopted by many of the existing vaccines used throughout the world.
Although the vaccines have yet to receive regulatory approval for widespread use, they have already been administered to hundreds of thousands of people in China under an emergency use program. That has raised concerns among scientists about the potential risks of using vaccines whose safety has yet to be thoroughly studied.
CNBG has said that its phase III trials, involving more than 50,000 people in countries from Argentina to Egypt, have progressed smoothly and it has not received any reports of serious adverse events.
Safety has become a major concern as drug manufacturers reduce the vaccine development process from years to a matter of months. AstraZeneca Plc and Johnson & Johnson stopped their trials after a participant developed an unexplained illness. Another Chinese leader, Sinovac Biotech Ltd., also had its trial in Brazil briefly interrupted after the death of a participant. All three trials were resumed after the researchers found no evidence that the events were caused by the vaccines.
Pfizer said this month that the injection it jointly developed with BioNTech has a protection rate of more than 90%. Russia later stated that its Sputnik V vaccine has achieved a 92% protection rate. CNBG has not released any public data on the effectiveness of its injections.
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