The “prequalified” stamp of approval means that these vaccines are consistently safe, effective and of high quality, and thus recommended for bulk purchase by the United Nations Children’s Fund (UNICEF) in 152 low and middle-income countries, the GAVI Alliance – which funds vaccines in 73 of these countries – and other agencies.  This does not indicate anything about suitability for USA or even EU markets Also,  just to check,  what batch-to-batch testing by non-industry watchdogs goes on with USA made drugs.