科兴疫苗审批被推迟了么?

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$未名医药(SZ002581)$ The World Health Organization is seeking more data on Sinovac Biotech Ltd.’s CoronaVac as it weighs whether to authorize a second Chinese Covid-19 vaccine under international pressure to help distribute more shots to poor countries.


In recent weeks, the WHO has asked for more details regarding the safety of the shot and requested data about Sinovac’s manufacturing process to assess whether it is compliant with WHO standards, according to people familiar with the matter. One senior WHO official now expects a decision to be delayed into June.


An emergency-use listing from the WHO could further global distribution of the vaccine. It could also pave the way for the Covax facility, led by WHO and other international organizations, which makes deals with vaccine manufacturers to buy vaccines for poor countries, to acquire more shots as it races to meet needs in the developing world.


Sinovac hasn’t said how many doses it could contribute to Covax. In recent months, Covax officials have been working to complete a deal to procure CoronaVac, seeking details on pricing, delivery schedules and volume, according to a person familiar with the conversations, though they have found it difficult to get satisfactory answers.


Western drugmakers such as AstraZeneca PLC, Johnson & Johnson and Pfizer Inc. are more familiar with the agency’s qualification process, and their vaccines have been approved for use by Covax. Sinovac’s relative inexperience has delayed authorization for its shot, according to WHO officials familiar with the process.




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