China sets biosafety standards for coronavirus vaccine makers
- Production of vaccine is still at least months away but some drug firms are already building plants to get candidates to market
- New rules more detailed than regime in place before, analyst says
The emergency standards apply to all facilities using pathogenic organisms to make vaccines but the five government agencies that issued the guidelines on Thursday stressed their application to coronavirus vaccine production plants.
“Safe and effective vaccines are important guarantees for the prevention and control of the novel coronavirus,” the agencies said.
“There is a level of biosafety risk when using pathogenic microorganisms to produce vaccines. [We] should ensure the quality of vaccines and the biosafety of places in which they are made.”
The agencies said the rules were based on domestic and international regulations and covered facilities, equipment and procedures.
At least one member of staff should be responsible for biosafety at each company but this should not be the person in charge of production, they said.
03:06
Chinese firm ready to make 100 million Coronavirus vaccine doses if trials are successful