SAHPRA holds J&J Covid-19 vaccine due to health concerns raised by USFDA
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Photo: SAHPRA
South African Health Products and Regulatory Authority (SAHPRA) has decided hold off Covid-19 vaccine doses from Johnson & Johnson due to concerns raised by the USFDA.
FDA raised a concern relating to non-compliance with Good Manufacturing Practices (GMP) at the Emergent plant in Baltimore, USA, during the manufacturing of drug substance which is used in the manufacture of the Covid-19 vaccine Janssen.
Subsequently, on 11 June 2021, the USFDA authorised two batches of drug substance produced from the Emergent site and further determined that several other batches are not suitable for use.
SAHPRA released a statement Sunday night that they have reviewed the data provided by the FDA and has made a decision not to release vaccine produced using the drug substance batches that were not suitable.
“However, there are approximately 300 000 doses from batches that have been cleared by the USFDA that meet the requirements and will subsequently be released and shipped to South Africa.”
“SAHPRA focuses on the quality, safety and efficacy of all health products, including COVID- 19 vaccines and will ensure that the safety and well-being of South Africans will not be compromised in any way,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
