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SA health regulator approves use of the Johnson & Johnson vaccine

The Johnson & Johnson vaccine has been given regulatory approval.

The South African Health Products Regulatory Authority (Sahpra) has approved the use of the Johnson & Johnson Covid-19 vaccine.

Permission was granted on March 31 in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965.

“The authorisation is, however, subject to a number of conditions, which includes that the vaccine is supplied and administered in accordance with the National Department of Health Covid-19 vaccination plan and applicable guidelines,” said Sahpra chief executive officer, Dr Boitumelo Semete-Makokotlela.

“Further conditions relate to the reporting of the results of ongoing studies and conformance with pharmaco-vigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates.”

The Johnson & Johnson Janssen vaccine is administered using a single dose injection.

Side effects, according to current clinical trial evidence, are usually mild or moderate and clear up within a few of days. The most common side effects are pain at the injection site, headache, tiredness, muscle pain and nausea.

President Cyril Ramaphosa has confirmed that South Africa has secured 30 million Johnson & Johnson vaccines; and that 220 million jabs will leave the Aspen Pharmacare’s production line for use across the African continent.

The President made the announcement on Monday when he and his deputy, David Mabuza, visited the Aspen Pharmacare sterile manufacturing facility at Gqeberha in the Eastern Cape.


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