Hopes are rising that Chinese Covid-19 vaccines may be among the first to receive regulatory approval, but analysts say hurdles remain before China becomes a key player in the global market, even if it produces a successful vaccine.
Zhang Yuntao, vice-president of the China National Biotec Group, part of Sinopharm, said earlier that preparations for “conditional approval” assessment had already begun for its two vaccines that, once granted, would permit them to be administered on the general Chinese public. Chinese vaccines may gain inroads overseas before they win conditional approval in China, via EULs granted by other national regulators. Last month, a Sinopharm experimental vaccine became the first Chinese Covid-19 candidate to receive an overseas EUL, from the United Arab Emirates which approved it for its frontline health workers.
Countries also face domestic pressure about using Chinese vaccines, with Brazil flip-flopping last week before its regulator on Friday finally approved the import of 6 million doses of the CoronaVac vaccine produced by Sinovac for its national immunisation programme. “There are only four Chinese pharmaceuticals that went through the World Health Organization prequalification procedures and to on the UN procurement list. That is mainly because Chinese manufacturers were not incentivised to get into the world market and, by their nature, vaccines are not high profit products.”
Beijing has promised to provide Covid-19 vaccines to several dozen developing countries, following President Xi Jinping’s pledge in May to make its vaccines a global public good. After months of hesitation, China finally agreed to join Covax, the vaccine distribution mechanism led by the Bill Gates-backed alliance Gavi, the Coalition for Epidemic Preparedness Innovations , and WHO.
So far, the Chinese front runners in Phase 3 clinical trials have not been included in the Covax vaccine portfolio, but both China and Gavi have indicated that more Chinese vaccines may be added to the portfolio. “I think the Covid-19 vaccines are quite different from the vaccines we heard in causing these scandals,” Bouey said. “For Covid vaccines, given the high stakes, they would be regulated by the central government … In terms of game players, it will be a different player so I am more assured with these high-stake products versus the routine vaccines.”
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