SAHPRA STILL AWAITS REPORT FROM THE US FDA ABOUT THE J&J VACCINE

Tue 08 June 2021:

The South African Health Products Regulatory Authority (SAHPRA) says it is in talks with the US Food & Drug Administration (FDA) after the agency halted the production of the Johnson & Johnson (J&J) vaccine.

The FDA is currently investigating potential good manufacturing practice (GMP) violations in the United States factory.

“SAHPRA is in continuous discussion with the FDA to ensure that this matter is resolved speedily,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Meanwhile, Semete-Makokotlela said 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 wellbeing of citizens are not compromised in any way.

SAHPRA registered the J&J vaccine on 31 March 2021, with conditions in terms of Section 15 (6a) of the Medicines and Related Substance Act 101 of 1965.

However, according to the country’s health sector watchdog agency, authorisation is subject to several conditions. This includes that the vaccine should be manufactured under 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,” SAHPRA explained.

According to a statement released on Monday, almost all the vaccines used in South Africa are manufactured in other countries, and SAHPRA requires documentation that confirms the quality from the regulatory authority in the country of manufacture.

“Through an arrangement called Reliance, SAHPRA has formal relationships with certain regulatory authorities that allows for the confidential exchange of information.”

For vaccine approvals, this allows SAHPRA to access reports produced by other regulatory agencies on inspections, testing and various other aspects of manufacturing and testing compliance.

“SAHPRA has a reliance arrangement with the FDA. In addition, SAHPRA relies on lot release testing undertaken by these partnering agencies, which involves reviewing manufacturing documentation and performing certain quality tests to ensure compliance with the approved and registered requirements.”

With the J&J vaccine, SAHPRA said the concern was identified by the FDA, relating to non-compliance to GMP at the plant in Baltimore during the manufacturing of some active pharmaceutical ingredient used in the vaccine.

“The non-compliant batch has been rejected. However, the incident has led to the investigation of four more batches by the FDA, and SAHPRA is awaiting reports from the 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 said it has insufficient information to approve specific batches of the J&J vaccine.