Tuesday, 08 February 2022

Pretoria: The South African Health Products Regulatory Authority (SAHPRA) announced on Monday that it has registered the MC Pharma also known as Sinopharm COVID-19 vaccine.

Initially developed by the Beijing Institute of Biological Products, the local drug watchdog said the Chinese two-dose COVID-19 jab is administered at an interval of two to four weeks apart.

“This authorisation is based on acceptable safety, quality and efficacy data submitted by MC Pharma Pty (Ltd) to SAHPRA as a rolling submission over the period 23 July 2021 to 22 December 2021,” the organisation explained.

In March last year, the World Health Organisation (WHO) listed Sinopharm for emergency use, giving the green light for this vaccine to be rolled out globally.

According to the WHO, vaccine efficacy for symptomatic and hospitalised was estimated to be 79%, all age groups combined.

The watchdog has also registered the Pfizer vaccine under section 15 from section 21, meaning it is now fully registered to be given to people 12 and older.

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

In South Africa, 22 791 139 doses of the Pfizer vaccine have already been administered.

The authorisation is, however, subject to some conditions for both vaccines.  These include that the vaccine is supplied and administered by the National COVID-19 vaccination programme, SAHPRA explained.

“Further conditions relate to the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates.”

In addition, adverse effects of the Sinopharm and Pfizer vaccines, as outlined in the clinical trial evidence submitted by the applicants, were usually mild or moderate and cleared within a few days.

They include injection on-site, headache, tiredness, muscle pain, nauseous, while Pfizer reported two additional side effects – muscle pain and chills.

So far, SAHPRA has registered the Pfizer, Johnson & Johnson (J&J), Sinopharm and also authorised Sinovac vaccines.

However, only two vaccines, Pfizer and the J&J are currently being rolled out in the country.

“The registration of these vaccines is a vast stride in vaccine registration as SAHPRA plays its role in the fight against COVID-19. SAHPRA will continue to play its part in ensuring the quality, safety and efficacy of all health products, including all vaccines to ensure that the South African public is protected at all times.” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.