Some J&J vaccines will not be used in SA says health products regulator
SA is heavily reliant on the J&J vaccine to meet a target of inoculating two-thirds of its population this year
SA will not allow some Johnson & Johnson Covid-19 vaccines to be used after a US ruling that ingredients for the country’s doses may have been contaminated during production in a plant in Baltimore, US.
The US Food and Drug Administration (FDA) said Friday that some batches of the J&J version were not fit to use, while others are still under review.
SA authorities have reviewed data provided by the FDA and “made a decision not to release vaccine produced using the drug substance batches that were not suitable,” the South African Health Products Regulatory Authority (Sahpra) said Sunday in a statement.
SA is heavily reliant on the J&J vaccine to meet a target of inoculating two-thirds of its 60-million population this year, having ordered more than 31-million of the single-dose shot.
Aspen Pharmacare Holdings Ltd., Africa’s largest drugmaker, has a contract to fill and package the doses at a factory in the coastal town of Gqebherha, until recently known as Port Elizabeth.
“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 SA,” the regulator said.
The news still marks a major setback in SA’s vaccine rollout — just as a third wave of infections is gathering pace. The government has been heavily criticised for delays in ordering doses, and inoculations to the public only began in mid-May.
The over-60s are receiving doses of the Pfizer and BioNTech SE’s version, though just 1.2-million people plus 480,000 health workers have been catered to so far.
Bloomberg News. More stories like this are available on bloomberg.com
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