However, SAHPRA said overnight it had registered the Covid-19 vaccine on March 31, with conditions including that it should be manufactured under conditions of good manufacturing practices (GMP) as determined by SAHPRA and aligned with global best practice.
“The manufacturing process of a vaccine and its active pharmaceutical ingredient requires stringent quality checks to ensure that the end product meets the requisite standards.
“Nearly all the vaccines used in SA are manufactured in other countries, and SAHPRA requires documentation that confirms the quality of these vaccines from the regulatory authority in the country of manufacture,” it said.
“A concern was identified by the FDA, relating to non-compliance to GMP at the Emergent plant in Baltimore, US, during the manufacturing of some active pharmaceutical ingredient used in the Janssen Covid-19 vaccine.
“The non-compliant batch D has been rejected; however, the incident has led to the investigation of four more batches by the US FDA, and SAHPRA is awaiting reports from the US FDA on whether 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 [J&J] Covid-19 vaccine.”
SAHPRA CEO Dr Boitumelo Semete-Makokotlela said: “SAHPRA is in continuous discussion with the USFDA to ensure that this matter is resolved speedily.
“SAHPRA will take all the necessary steps to ensure that the vaccines that are administered to South Africans meet all the requisite stringent standards so that the health and well being of all who live in SA are not compromised in any way.”