On Monday, the South African Health Products Regulatory Authority (SAHPRA) announced that it has registered the MC Pharma also known as the Sinopharm Covid-19 vaccine.
The Sinopharm vaccine was initially developed by the Beijing Institute of Biological Products. And according to SAHPRA, it is a two-dose jab 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,” SAHPRA explained.
Sinopharm was approved by the World Health Organisation (WHO) in March 2021 and listed the vaccine for “emergency use”. It was then given the go-ahead to be administered globally.
SAHPRA administeres Sinopharm under certain conditions
The administration of the vaccine comes with some conditions.
This includes that “vaccine is supplied and administered by the National COVID-19 vaccination programme”.
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.”
Furthermore, the effects of the Sinopharm vaccine were usually mild and should clear within a couple of days.
The clinical trial applicants reported the following side effects once the jab has been received:
- Muscle pain
Pfizer vaccine officialy “fully registered”
WHO has also officially registered the Pfizer vaccine, which was previously only approved for emergency use only. Thus, Pfizer is now fully registered to be given to people age 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.
Since the pandemic, SAHPRA has registered Pfizer, Johnson & Johnson (J&J), Sinovac and now also the Sinopharm vaccines. However, only two vaccines – Pfizer and J&J – are currently available in South Africa.
“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.
Media Statement: SAHPRA registers Chinese Sinopharm COVID-19 vaccine