South African Health Products Regulatory Authority (SAHPRA) says it will not release the 2 million doses of the Johnson & Johnson (J&J) COVID-19 vaccines at the Aspen plant in Gqerberha meant for distribution in South Africa.
In a statement on Sunday, SAHPRA confirmed that the vaccines were affected by contamination issues at a US vaccine plant in Baltimore.
US Food and Drug Authority (FDA) which had halted the release of all J&J vaccines in May, pending an investigation, on Friday cleared some of the batches at the plant, but confirmed that 60 million doses were contaminated and had to be destroyed.
In addition, the batches that were approved have to carry a warning sign.
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela confirmed an earlier statement by the Department of Health that 300 000 doses of the FDA approved doses will be released for shipment to South Africa.
She reiterated that SAHPRA is committed to the quality and safety of all health products and that it will ensure that the safety and well-being of South Africans will not be compromised in any way.
Find SAHPRA Press Statement Below
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.