SAHPRA pulls SA's J&J vaccines over safety concerns

SAHPRA pulls SA’s J&J vaccines over safety concerns

By Kaya 959 News

The South African Health Products Regulatory Authority (SAHPRA) has decided to pull the country’s stock of Johnson & Johnson vaccines.

The regulatory body said on Sunday that it decided “not to release vaccine produced using the drug substance batches that were not suitable”.

SAHPRA CEO Dr Boitumelo Semete Makokotlela said there are approximately 300 000 doses from batches that have been cleared by the US Food and Drug Administration that meet the requirements and will subsequently be released and shipped to South Africa.

“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,” said Semete-Makokotlela.

READ: Vaccine Inequity: WHO urges wealthy countries to donate doses through Covax

Millions of J&J vaccines destroyed

Last week, the Food and Drug Administration announced that millions of J&J vaccines could be destroyed due to contamination concerns.

The FDA said the vacines were not suitable for use.

Director of the FDA’s Center for Biologics Evaluation and Research, Dr Peter Marks, said these actions followed an extensive review of records including the production history of the facility and the testing performed to evaluate the quality of the product.

On Friday the Department of Health said SA’s batch of J&J vvaccines were awaiting distribution from the Gqebherha plant need further assessment by the South African Health Products Regulatory Authority and SAHPRA will soon advise if they are suitable for use in South Africa.

“There is now a real possibility that they may not be, however this is for the regulator to rule on,” the department said.

“In total, 300 000 doses are cleared to be shipped to South Africa as a matter of extreme urgency. Furthermore, the FDA announced that, after careful evaluation of these doses, they approved an extension of the expiry date after determining that the vaccine can be stored in 2-8 degrees celsius (normal bar fridge) for 4,5 months instead of 3 months,” the department added.

Women complain of blood clots

It said work is being undertaken to identify more safe doses for the rest of the mass vaccination programme.

“We further note that the FDA is still evaluating some batches and we will await those outcomes, in the hopes that this will make more doses of Johnson and Johnson available to the international community, including South Africa,” the department said.

Earlier this year, the rollout of the J&J vaccine was halted after at least eight women in America complained of blood clots after being vaccinated.

The doses to be discarded were produced at the Emergent BioSolutions laboratory in Baltimore in the United States. The facility has previously discarded ingredients for around 15m doses in April as a result of contamination with materials from the AstraZeneca jab which was also manufactured at the same plant.

In April, NBC News reported that federal inspectors visited the lab where they found the lab was not maintained in a clean and sanitary condition.

As per the report, inspectors found peeling paint and unidentified black and brown residue on the floors and walls, as well as a failure to properly decontaminate waste generated during the manufacture of the vaccine drug substance.

A FDA report alleged that the company failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances.

Written by: Tamlyn

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