The South African Health Products Regulatory Authority (SAHPRA) announced on Monday the registration of the Janssen Covid-19 vaccine on March 31, with conditions.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela explained that one of the conditions is that the vaccine be manufactured under conditions of Good Manufacturing Practices (GMP) as determined by SAHPRA and aligned with global best practice.
SAHPRA will seek documentation from the regulatory authority in the country manufacturing the vaccine.
Meanwhile, the SAHPRA is in discussion with the US Food and Drug Administration (FDA) around concerns with a non-compliant batch of vaccines.
This has led to an investigation of more batches by the US FDA.
“…and SAHPRA is awaiting reports from the US FDA on whether or not these other batches were manufactured according to GMP standards and if the batches are contaminated. Until the FDA has shared these reports, SAHPRA has insufficient information to approve specific batches of the Janssen Covid-19 vaccine,” the SAHPRA said in a statement.
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