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Sahpra approves J&J vaccine with conditions

Sahpra approves J&J vaccine with conditions The South African Health Products Regulatory Authority (Sahpra) has registered the Covid-19 Johnson & Johnson vaccine in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, with conditions. 123rf.com“This registration signals a significant step in the fight against the Covid-19 pandemic,” said Sahpra CEO, Dr Boitumelo Semete-Makokotlela. The authorisation is based on acceptable safety, quality and efficacy data submitted by Janssen Pharmaceutica (Johnson & Johnson) to Sahpra as a rolling submission between 11 December 2020 and 17 March 2021. “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.

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