SAHPRA update COVID-19 Vaccine Janssen – FDA Developments

13 June 2021

SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965.

The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for active immunisation against SARS-CoV-2.

The authorisation is, however, subject to a number of conditions which include that the vaccine should be manufactured under conditions of Good Manufacturing Practices (GMP) as determined by SAHPRA and aligned with global best practice.

A concern was identified by the USFDA, relating to non-compliance with GMP at the Emergent plant in Baltimore, USA, during the manufacturing of drug substance which is used in the manufacture of the Covid-19 vaccine Janssen.

Subsequently, on 11 June 2021, the USFDA authorised two batches of drug substance produced from the Emergent site and further determined that several other batches are not suitable for use. SAHPRA reviewed the data provided by the FDA and has made a decision not to release vaccine produced using the drug substance batches that were not suitable.

However, there are approximately 300 000 doses from batches that have been cleared by the USFDA that meet the requirements and will subsequently be released and shipped to South Africa.

“SAHPRA focuses on the quality, safety and efficacy of all health products, including COVID- 19 vaccines and will ensure that the safety and well-being of South Africans will not be compromised in any way,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Download PDF