By Lehlohonolo Lehana.
The South African Health Products Regulatory Authority (SAHPRA) has endorsed the FDA decision that the 2 million doses of the Johnson & Johnson (J&J) COVID-19 vaccines at the Aspen plant in Gqerberha will not be released for distribution in South Africa.
In a statement, the regulator confirmed that the vaccines were affected by contamination issues at a US vaccine plant in Baltimore. The US Food and Drug Authority (FDA) last month halted the release of all J&J vaccines from the plant pending an investigation.
On Friday, the FDA said that some batches of the J&J version were not fit to use, while others are still under review. Two lots have been approved, though it’s not clear where those are headed or how many that covers.
The concerns by the FDA as set out in a notice included:
- Concerns over the training of operators and a decision to “abandon the recipe” and initiate a new one;
- The building where ingredients were manufactured did not comply with sanitation and cleanliness requirements;
- The paint in the manufacturing facility was peeling from the walls and inspectors found paint flecks on the floor;
- Inspectors also found a “black substance” and “brown substance” on the walls;
- Medical waste was not decontaminated properly;
- Employees handling medical waste at the facility did not comply with rules and were for instance observed throwing open bags of medical waste into a service elevator;
- Workers were seen compacting medical waste in the same area where the ingredients for the vaccine were manufactured;
- Workers failed to observe protocols to prevent cross-contamination of ingredients.
South Africa 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, Africa’s largest drug maker, has a contract to fill and package the doses at a factory in the coastal town of Gqebherha – until recently known as Port Elizabeth.
In the statement, SAHPRA CEO Dr Boitumelo Semete-Makokotlela said that after reviewing the data provided by the FDA, it has “made a decision not to release vaccines produced using the drug substance batches that were not suitable”.
“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.”
SAHPRA had registered the Covid-19 vaccine on 31 March 2021, with conditions that included that the vaccine should be manufactured under conditions of Good Manufacturing Practices (GMP) as determined by SAHPRA and aligned with global best practice.