A major Chinese vaccine developer has applied for authorization to bring its Covid-19 injection to market, seeking to get ahead of its western rivals as the race for a functional inoculation against the virus 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 is likely to include interim 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 pharmaceutical companies such as Pfizer Inc. and AstraZeneca Plc are only at the stage of requesting authorization for the emergency use of their injections, a status that China granted its developers months ago.
But unlike Western pioneers, CNBG has yet to release any public data on the effectiveness of its injections in Phase III trials, making it difficult to compare its vaccines to others or estimate how quickly it is likely to receive approval.
The regulator will now review data from CNBG’s Phase I and II trials, in addition to interim data from its Phase III trials, which President Yang Xiaoming said last week that the company has just begun to clarify. China’s drug regulator, the National Medical Products Administration, did not immediately respond to requests for comment.
The vaccine race has assumed vital importance as countries seek to permanently reopen their economies and halt a pandemic that has sickened more than 59 million. Vaccines 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.
These vaccines have the advantage that their storage and distribution are easier, since they do not need to be frozen, unlike the experimental mRNA vaccines being developed by Pfizer and Moderna Inc. CNBG injections can be stored at normal refrigerator temperatures, allowing access to rural areas and developing countries are more likely.
CNBG has vaccine supply agreements with several developing countries, including Malaysia, Brazil, Pakistan and the United Arab Emirates, according to public reports compiled by Bloomberg. Leading Western developers like AstraZeneca and Pfizer have signed deals with many more countries.
Despite the fact that the vaccines have yet to receive regulatory approval for widespread use, hundreds of thousands of people have already been dosed 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 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%. This high level of efficacy was also seen in the Moderna shots, which use similar mRNA technology. AstraZeneca’s vaccine, a viral vector developed with the University of Oxford, prevented an average of 70% of participants from getting sick, a preliminary analysis showed.
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