28 Sep Update on COVID-19 health products
UPDATE ON COVID-19 HEALTH PRODUCTS: SAHPRA registers the Covovax COVID-19 vaccine from Cipla (Pty) Ltd and additional indication of use of COVID-19 vaccine MC Pharma from MC Pharma (Pty) Ltd in the age group 3 -17 years.
Pretoria, 28 September 2022 – SAHPRA registered a COVID-19 vaccine: the Covovax vaccine submitted by Cipla (Pty) Ltd on 16 August 2022.
Furthermore, SAHPRA approved the additional indication of the use of the COVID-19 vaccine MC Pharma in the age group 3 to 17 years on 16 September 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. This means that these products are not under Emergency Use Authorisation but have a full registration.
Covovax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. Covovax is administered intramuscularly as a course of two doses of 0,5 ml each. It is recommended to administer the second dose three weeks after the first dose. It is also recommended that individuals who receive a first dose of Covovax, complete the vaccination course with Covovax.
This authorisation is based on acceptable safety, quality and efficacy data submitted by Cipla (Pty) Ltd to SAHPRA as a rolling submission. 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 Covovax 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. Very common adverse events reported were injection site pain, injection site tenderness, fatigue, malaise headache, myalgia, arthralgia, and nausea. Very rare cases of decreased appetite, diarrhoea, chills, dizziness and somnolence have been observed following vaccination with Covovax.
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 3-17 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 of the 3-17 years use is based on acceptable safety, quality and efficacy data submitted by MC Pharma Pty (Ltd) to SAHPRA as a variation to the already registered MC Pharma (Pty) Ltd.
“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.