FDA clears 300 000 doses of J&J vaccine to be shipped to SA
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Cape Town - Approximately 300 000 does of the Johnson and Johnson (J&J) vaccine will be released and shipped to South Africa, after there was a hold-up due to manufacturing concerns by the United States Food and Drug Administration (FDA).
This comes after the FDA raised concerns over the production of the vaccine at the Emergent BioSolutions facility in Baltimore, United Statest, where millions of potential doses were contaminated.
On Friday, the FDA announced that it was authorizing two batches of J&J Covid-19 vaccines for use, while other batches were thrown out.
South African Health Products Regulatory Authority (SAHPRA) registered the Covid-19 Vaccine on 31 March 2021, with 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.
SAHPRA reviewed the data provided by the FDA and made a decision not to release vaccine produced using the drug substance batches that were not suitable.
However, SAHPRA said that there are approximately 300 000 doses from the two batches cleared by the FDA meet the requirements and will subsequently be released and shipped to South Africa.
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela said: “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.”
Meanwhile SA's batch of Johnson and Johnson vaccines awaiting distribution from the Gqebherha plant need further assessment by SAHPRA. According to the Department of Health, SAHPRA will soon advise if they are suitable for use.