After reviewing data provided by the US Food and Drug Administration (FDA)‚ the SA Health Products Regulatory Authority (Sahpra) has decided to discard some of the Johnson & Johnson (J&J) Covid-19 vaccines meant for SA.

The authority said it will release 300‚000 J&J vaccines cleared by the FDA and the doses will be shipped to SA.

Here is what you need to know:

Vaccines not suitable

On Sunday‚ Sahpra CEO Boitumelo Semete-Makokotlela said the authority made a decision not to release the vaccines that were not suitable.

“Sahpra focuses on the quality‚ safety and efficacy of all health products‚ including Covid-19 vaccines‚ and will ensure the safety and wellbeing of South Africans will not be compromised in any way‚” said Semete-Makokotlela.

Sahpra had registered the Covid-19 vaccine on March 31‚ 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.

About 60 million doses being discarded

Sahpra said a concern was identified by the FDA relating to non-compliance with GMP at the emergent plant in Baltimore in the US during the manufacturing of a drug substance used in the manufacture of the Covid-19 vaccine.

“Subsequently‚ on June 11‚ the FDA authorised two batches of drug substance produced by the emergent site and further determined several other batches are not suitable for use‚” it said.

The New York Times reported that the batches being discarded amount to around 60 million doses.

“The FDA has determined several other batches are not suitable for use‚ but additional batches are under review and the agency will keep the public informed as those reviews are completed‚” said the FDA.

J&J is ‘committed to producing safe‚ high-quality vaccines’

J&J confirmed the authorisation of the two batches and said the decision would allow the company to continue its efforts to curb the Covid-19 pandemic.

“Since establishing our Covid-19 vaccine program‚ J&J has committed to producing safe‚ high-quality vaccines to bring health and hope to people everywhere‚” said Kathy Wengel‚ the company’s executive vice-president and chief global supply chain officer.

“Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale‚ and we appreciate the close collaboration with the FDA and global health authorities.”

Health department notes J&J’s move

The health department noted the statement issued by J&J.

According to the department‚ vaccines awaiting distribution from the Gqebherha plant in the Eastern Cape need further assessment by Sahpra.

“There is a real possibility they may not be. However‚ this is for the regulator to rule.

“In total‚ 300‚000 doses are cleared to be shipped to SA 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 the vaccine can be stored at 2°C to 8°C (normal bar fridge) for 4‚5 months instead of three months. Work is being undertaken to identify more safe doses for the rest of the mass vaccination programme‚” said the department.

It also noted the FDA was evaluating some batches and will wait for the outcomes in the hopes this will make more doses of the J&J vaccine available in SA.

“Further announcements will follow in due course. We remain committed to the success of the SA mass vaccination campaign and are doing everything in our power to source safe and effective vaccines for all people residing in the country.”


Source: ARENA Holdings.