Coronavirus: Sinopharm applies for regulatory approval from China to launch vaccine, state media reports
- Chinese pharmaceutical giant files for regulatory approval, according to Xinhua Finance
- China National Biotec Group executive says data review is not complete but Sinopharm chairman says vaccines are protective and safe
China National Pharmaceutical Group, known as Sinopharm and whose subsidiary company China National Biotec Group is developing two inactivated coronavirus vaccines, has filed for regulatory approve to launch the vaccines, Xinhua Finance reported on Tuesday, citing Sinopharm’s vice-general manager, Shi Shengyi.
The brief report did not specify which – or even how many – of the candidates would be reviewed. The two candidates, developed by different institutes under CNBG, have been testing for broad safety and efficacy, or how protective they are against unvaccinated groups, in 10 countries across South America and the Middle East. The safety and efficacy data has not been published.
But a senior CNBG executive, who preferred anonymity because the matter was sensitive, said the report by Xinhua Finance was “inaccurate” and the company had yet to file for an official launch. He also said the phase 3 data review had not been completed.
CNBG was contacted for official comment about the application to launch its product but did not respond.