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Leading The Chinese vaccine developer has Applied for authorization to market its Covid-1 shot, trying to get a jump in the race for the inoculation race to work against the virus on Western competitors.
China National Biotech Group has sent an application to Chinese regulators, citing Xi Shengi, vice general manager of parent company Sinofarm, state media reported to Xinhua Finance. The application may contain interim data from the company’s Phase III human testing, which may have been conducted in the Middle East and South America.
Shares of Synform Group, including its Hong Kong unit, rose on Wednesday after the news broke.
A CNBG spokesman said it had no further information when contacted by Bloomberg. Synopharm group calls were unanswered.
With this application, CNBG will probably become the first developer outside Russia to see its shots made available to the general public, emphasizing China’s determination to provide inoculation in the countries of the world. Pfizer Inc. And while Western drug makers like AstraZeneca PLC are only in the process of gaining authorization for the emergency use of their shots, this status China gave to its developers months ago.
But unlike the Western front, CNBG has not yet released any public data about the effectiveness of its shots in Phase III trials, making it difficult to compare its vaccines with others, or estimate how quickly it is likely to be approved.
The regulator will now review data from CNBG’s Phase I and II trials, as well as interim data from its Phase III trials, chaired by Yang Xiaoming. Said last week that the company has just started un-blinding. China’s drug regulator, the National Medical Products Administration, did not immediately respond to requests for comment.
Countries have made the race for vaccinations important to open up their economies more clearly and to curb the more than one million million epidemics. Inoculations are seen as the best Hope A fresh wave of infection is forcing nations to reintroduce lockdowns and other sanctions.
The traditional method
CNBG, a state-owned pharmaceutical company with a strong share of China’s vaccine market, was among the first in the world to push an experimental shot into the critical final phase of human testing in April. The company’s research institutes developed one shot using two An inactivated version of the virus to stimulate the immune response, an approach widely adopted by many vaccines used worldwide.
Such vaccines have the advantage of easy storage and distribution as they do not need to be Stable – Unlike experimental mRNA vaccines by Pfizer and Moderna Inc. No shots can be stored at normal refrigerator temperatures, making access to rural areas and developing countries possible.
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 such as AstraZeneca and Pfizer have entered into agreements with many more countries.
Despite the fact that vaccines have not yet received regulatory approval for widespread use, the dose has already been given to hundreds of thousands of people in China under one Emergency use program. Which has raised concerns among scientists about the potential dangers of using shots that have yet to be fully studied for their safety.
CNBG said its third phase trial – involving more than 50,000 people in countries from Argentina to Egypt – was progressing smoothly, and it had not received any news of serious adverse events.
Race to China Covid-19 The vaccine raises safety questions
Safety has become a major concern as drug manufacturers have been slowing down the vaccine development process for years to months. AstraZeneca and Johnson and Johnson suspended their trials after a participant developed an explanatory illness. Another Chinese front, Synovac Biotech Ltd., also saw its trial All three trials were resumed after investigators found evidence that the incidents were caused by vaccines.
Pfizer The defense rate of shots developed in collaboration with Bioentech is more than 90%, it said this month. This high level of effectiveness was also seen in the shots of Moderna, which have similar uses MRNA technology. AstraZeneca vaccine, a viral vector developed with Ast Oxford University, prevents an average of 70% of participants from getting sick, early The analysis showed.
– With the help of John Liu, Dong Liu and Claire Cheney
(During updates)
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