Sahpra CEO, Dr Boitumelo Semete-Makokotlela, said on Sunday: “A concern was identified by the US FDA, relating to non-compliance with GMP at the Emergent plant in Baltimore, US, during the manufacturing of a drug substance which is used in the manufacturing of the Covid-19 vaccine Janssen.”
“Subsequently, on June 11 2021, the US FDA 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 vaccines 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 US FDA that meet the requirements and will subsequently be released and shipped to South Africa.”
She assured South Africans of the safety of the vaccine doses.
“Sahpra focuses on the quality, safety and efficacy of all health products, including Covid-19 vaccines, and will ensure that the safety and wellbeing of South Africans will not be compromised in any way.”
It is unclear how many of the SA doses are affected by the FDA decision. Earlier this year, the government said J&J had aimed to supply 2.8 million doses to SA in the second quarter of the year.
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300,000 J&J Covid vaccine doses will be used in SA, but the rest are unsuitable
As the third wave of Covid-19 infections hit the country, the SA Health Products Regulatory Authority says about 300,000 doses of the J&J vaccine will be safe to use and will be shipped to SA.
These are from batches that have been cleared by the US Food and Drug Administration (FDA).
The FDA on Friday said Johnson & Johnson must throw away millions of doses of its Covid-19 vaccine that were manufactured at a Baltimore factory.
This was after the discovery in April that ingredients from AstraZeneca's Covid vaccine, also being produced at the plant at the time, contaminated a batch of J&J's vaccine.
Sahpra CEO, Dr Boitumelo Semete-Makokotlela, said on Sunday: “A concern was identified by the US FDA, relating to non-compliance with GMP at the Emergent plant in Baltimore, US, during the manufacturing of a drug substance which is used in the manufacturing of the Covid-19 vaccine Janssen.”
“Subsequently, on June 11 2021, the US FDA 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 vaccines 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 US FDA that meet the requirements and will subsequently be released and shipped to South Africa.”
She assured South Africans of the safety of the vaccine doses.
“Sahpra focuses on the quality, safety and efficacy of all health products, including Covid-19 vaccines, and will ensure that the safety and wellbeing of South Africans will not be compromised in any way.”
It is unclear how many of the SA doses are affected by the FDA decision. Earlier this year, the government said J&J had aimed to supply 2.8 million doses to SA in the second quarter of the year.
TimesLIVE