SAHPRA registers two COVID-19 vaccines

SAHPRA has registered two COVID-19 vaccines: the COMIRNATY vaccine by Pfizer Laboratories (Pty) Ltd on 25 January 2022, and the COVID-19 VACCINE MC PHARMA by MC Pharma (Pty) Ltd. on 31 January 2022.

Both vaccines have been registered in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965 as Amended), with conditions.

SAHPRA registers COVID-19 vaccines
The registration of these vaccines is a vast stride in vaccine registration as SAHPRA plays its role in the fight against COVID-19. Photo by Mufid Majnun on Unsplash

COMINARTY vaccine

COMIRNATY is an mRNA vaccine, indicated for active immunisation to prevent COVID-19 in individuals 12 years of age and older. COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0,3 mL each). It is recommended that the second dose is administered three weeks after the initial dose.

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 authorisation is, however, subject to a number of conditions which includes that the vaccine is supplied and administered in accordance with the National COVID- 19 vaccination programme and applicable guidelines. 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.

The adverse effects of the COMIRNATY vaccine, as outlined in the clinical trial evidence submitted by the applicant, were usually mild or moderate and cleared within a few days of vaccination. The most common adverse effects reported were pain at the injection site, headache, tiredness, muscle pain and chills. Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY. These cases have primarily

occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Available data suggest that the course of these conditions following vaccination is not different from that seen with myocarditis or pericarditis from other causes.

COVID-19 VACCINE MC PHARMA

The COVID-19 VACCINE MC PHARMA is an inactivated Vero Cell vaccine, indicated for immunisation against SARS-CoV-2 in those aged 18 years and older. Initially developed by the Beijing Institute of Biological Products Co., Ltd, this product has also been referred to as the Sinopharm/BIBP vaccine indicated for immunisation against SARS-CoV-2. The COVID-19 VACCINE MC PHARMA is administered as two doses by intramuscular injection at an interval of 2-4 weeks and each dose is 0.5ml.

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 authorisation is, however, subject to a number of conditions which includes that the vaccine is supplied and administered in accordance with 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.

The adverse effects of the COVID-19 VACCINE MC PHARMA, as outlined in the clinical trial evidence submitted by the applicant, were usually mild or moderate and cleared within a few days of vaccination. The most common adverse effects reported were pain at the injection site, headache, tiredness, muscle pain and nausea.

“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,” indicates SAHPRA CEO, Dr Boitumelo Semete- Makokotlela.

Visit the official COVID-19 government website to stay informed: sacoronavirus.co.za