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China National Biotec Group Co. (CNBG), a leading vaccine developer has sought authorisation to bring its COVID-19 candidate to the current market, Bloomberg has reported.
The Bloomberg report cites Shi Shengyi, the vice general director of Sinopharm — CNBG’s parent company — as saying that an application in this regard was submitted to Chinese regulators on November 25. The application is likely to include data from the phase-3 clinical trials that were conducted at the Middle East and South America.
CNBG, Sinopharm Group and China’s drug regulator, the National Medical Products Administration, didn’t immediately confirm that development.
This would create CNBG the first drugmaker outside Russia to find general usage authorisation for its vaccine candidate against COVID-19, the disease caused by the novel coronavirus.
The move is being seen as an attempt to challenge rivals from the United States and the United Kingdom as the race to develop a vaccine against COVID-19 heats up. Western vaccine developers like Pfizer, Moderna and AstraZeneca are yet to formally seek emergency employment authorisation from regulators.
CNBG had said its phase-3 human trials involved more than 50,000 individuals in countries such as Argentina to Egypt and had progressed smoothly. It had also said there had been no serious adverse events. But, unlike its Western rivals, CNBG is yet to release phase-3 efficiency data of its vaccine candidate. Thus, it remains uncertain how fast will the shot be accepted by the Chinese regulators.
The news report suggests CNBG has signed supply agreements with multiple countries such as Malaysia, Brazil, Pakistan and the United Arab Emirates (UAE).
Over 5.9 crore people are infected with the disease so far resulting in over 14 lakh deaths. While the amount of new COVID-19 instances being reported has fallen in some countries, others fear a second wave of infections. Quick and effect inoculation has been seen as the only way to end the pandemic.
Yet, despite offenses having not been accepted, they are already in widespread use. Thousands and thousands of people in China are believed to have been inoculated under an emergency-use program, leading to concerns in the scientific community.