Two million Johnson & Johnson vaccines at the Gqeberha plant will no longer be used.
This was announced by Acting Minister of Health Mmamoloko Kubayi-Ngubane on Saturday during a visit at Chris Hani Baragwanath Academic Hospital in Soweto as part of her national tour.
The announcement came shortly after the US Food and Drug Administration ( FDA) decided to discard about 60 million doses made at the Baltimore plant due to contamination.
Kubayi-Ngubane admitted that the contamination of the vaccines is a major setback to the country’s immunisation campaign.
“We can’t ignore the fact that it takes our vaccine to roll out a bit backwards,” said Kubayi-Ngubane.
The South African Health Product Regulator (SAHPRA) Spokesperson Yuven Gounden also confirmed that two million vaccines made in Gqberha plant will no longer be used, but said that a batch of 300 000 J&J doses will be shipped to the country as a matter of urgency.
“A concern was identified by the USFDA, relating to non-compliance with Good Manufacturing Practices (GMP) at the Emergent plant in Baltimore, USA, as determined by SAHPRA and aligned with global best practice,” said Gounden.
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.
“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,” reads Sahpra’s statement.
The regulator said that it will ensure that the safety and well-being of South Africans will not be compromised in any way.