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New jab on the vaccine block: Sinopharm registered by Sahpra

Sahpra CEO Dr Boitumelo Semete-Makokotlela says the process of assessing vaccines is rigorous and intricate. File photo.
Sahpra CEO Dr Boitumelo Semete-Makokotlela says the process of assessing vaccines is rigorous and intricate. File photo.
Image: Supplied

South Africans have become familiar with the Pfizer-BioNTech (known as the Comirnaty vaccine) and Johnson & Johnson vaccines which, to date, are the only vaccines rolled out against Covid-19 in the country.

Sinovac is also registered but has not been part of the mass rollout yet as trials continue.

The SA Health Products Regulatory Authority (Sahpra) has announced the authorisation of another vaccine called MC Pharma, or as it is more commonly known, Sinopharm.

It has also registered Pfizer’s Comirnaty vaccine under section 15.

Nearly 23-million doses of the Comirnaty vaccine have been administered in the country, but this has been done under section 21, which means access is granted to an unregistered product. 

The move to section 15 means it is fully registered.

“The registration of these vaccines is a vast stride in vaccine registration as Sahpra plays its role in the fight against Covid-19,” said Sahpra CEO Dr Boitumelo Semete-Makokotlela.

“Sahpra will continue to play its part in ensuring the quality, safety and efficacy of all health products, including all vaccines, to ensure the South African public is protected at all times.”

While Comirnaty is an mRNA vaccine authorised for use in individuals aged 12 and older, Sinopharm is an inactivated Vero Cell vaccine and will only be given to those 18 and older.

Being an inactivated Vero Cell vaccine means Sinopharm uses a weakened or deactivated form of the pathogen that causes Covid-19 to trigger protective immunity. 

Sahpra said the authorisation of Comirnaty “is based on acceptable safety, quality and efficacy data submitted by Pfizer Laboratories (Pty) Ltd to Sahpra as a rolling submission over the period February 3 2021 to January 17 2022”.

The adverse effects of the vaccine, as outlined in the clinical trial evidence, were usually mild or moderate and cleared within a few days of vaccination.

According to the World Health Organisation, Sinopharm’s “easy storage requirements make it highly suitable for low-resource settings”.

Details of the rollout will be defined and announced by the health department.



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