WHO today removed a freeze-dried BCG vaccine for the prevention of tuberculosis from its list of prequalified vaccines for procurement by UN agencies. The decision follows a number of evaluation activities carried out by WHO to monitor the performance of both the vaccine and its manufacturer, GreenSignal Bio Pharma Pvt Ltd., India.
Alternative sources of prequalified BCG vaccines are available.
The Freeze-Dried BCG vaccine in question was prequalified by WHO in November 2015. As part of its efforts to ensure continued supply of quality-assured vaccines, WHO has recently carried out post prequalification monitoring activities – namely, target independent testing, submission and assessment of Prequalified Vaccine Annual Reports and inspections of the manufacturing site.
The outcome of the WHO inspections of the manufacturing site, and the company’s response to the findings of those inspections were not satisfactory. The last two WHO inspections concluded that the company was operating at unacceptable levels of compliance with WHO guidelines on good manufacturing practices, potentially endangering the performance of the vaccine and posing a high risk to recipients.
WHO will proceed to the immediate removal of the vaccine from the WHO list of prequalified health products and recommends continued vaccination with prequalified BCG vaccines from alternative sources.
WHO has advised GreenSignal Bio Pharma Pvt Ltd., India to take appropriate action, including immediate recall of remaining vials of the lots of the freeze-dried BCG vaccine manufactured and distributed in 2019.