HEALTHCARE workers who received the Johnson & Johnson (J&J) vaccines under the phase 1 Sisonke implementation study are urged not to panic and worry, following the news that 2 million J&J vaccines manufactured in Gqeberha in the Eastern Cape will be destroyed because one batch was regarded as contaminated by authorities in the US.
About 479 768 J&J vaccines were administered under phase 1, which gave priority to healthcare workers. Acting Health Minister Mamoloko Kubayi-Ngubane has assured healthcare workers that the vaccines used in phase 1 were not part of the contaminated batch.
“I need to reiterate that these contaminated batches have not been used. SA citizens should not panic. Vaccines they will receive will be approved,” she said.
Kubayi-Ngubane also conceded that these latest developments on the J&J vaccine would take SA’s vaccine rollout backwards.
Here are why millions of J&J vaccines were ordered to be destroyed:
What has happened
The problem arose at the Emergent Biosolutions manufacturing plant in Maryland in the US, which makes the active substance for the J&J vaccine as well as that of AstraZeneca.
The active substance became contaminated with materials intended for another vaccine, rendering them unusable.
The manufacturing plant was shut down by the FDA in April for making J&J Covid-19 vaccines with poorly trained workers in unsanitary conditions that allowed cross contamination of bulk drug substances. The facility has already destroyed ingredients for 15 million doses.
Among some problems FDA flagged was mould, poor disinfection of plant equipment and inadequate training of employees.
The US government awarded the company a $628 million contract last year to help make coronavirus vaccines.
Why is South Africa destroying 2 million J&J vaccines?
The vaccines have been waiting at an Aspen distribution plant in Gqeberha (Port Elizabeth) after it was discovered that a batch of the J&J vaccines manufactured at the Emergent BioSolutions plant in Baltimore had been contaminated.
Aspen Pharmaceuticals has a contract to fill and package the J&J doses and was due to supply over two million vaccines to the national vaccination programme.
Professor Mosa Moshabela, acting deputy vice-chancellor research & innovation – University of KwaZulu-Natal said: “The ingredients that are manufactured in the US may have come into contact with the ingredients for the AstraZeneca vaccine at that manufacturing facility and the J&J ingredients were then imported to South Africa to be mixed here which really is what the problem is.”
An estimated six to nine million doses are on hold worldwide because they were manufactured during the time of the original contamination in February.
What’s next?
In a statement by the South African Health Products Regulatory Authority (Sahpra), the regulatory body confirmed that 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.
Media Release:
— SAHPRA (@SAHPRA1) June 13, 2021
SAHPRA update Covid-19 vaccine Janssen – FDA Developments
Read more: https://t.co/y9pzpIrD1Q#SAHPRA #COVID19 #Janssen #vaccines #GMP #FDA
The batches will have to carry a warning and will now be stored for four and half months instead of three months, at a temperature of 2ºC to 8ºC.
Sahpra chief executive Dr Boitumelo Semete said the batches in question will not be released.
“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,”
The J&J vaccine is due to be used in the vaccination of teachers as soon as it is available.