By Lehlohonolo Lehana.
The South African Health Products Regulatory Authority (SAHPRA) has authorised the use of CoronaVac COVID-19 vaccine, manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd.
The authorisation was done in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965, a mechanism in the Medicines Act that enables emergency use access and also enables SAHPRA to authorise a medicine subject to certain conditions, said SAHPRA in a statement.
“CoronaVac is an inactivated whole virion vaccine derived from the SARS-CoV-2 virus (CZ02 strain). Each dose contains 600 SU of inactivated SARS-CoV-2 virus as the antigen. CoronaVac is indicated for active immunisation in individuals aged between 18 and 59 years against COVID-19, the disease caused by SARS-CoV-2 virus.”
The vaccine is administered as two doses of 0,5ml, given intramuscularly, with the second dose administered between 14 and 28 days after the first dose,said the regulator.
“This authorisation is based on the safety, quality and efficacy data submitted by Curanto Pharma (Pty) Ltd to SAHPRA between 22 March 2021 and 22 June 2021. Although the data submitted are considered acceptable at this point, the authorisation is subject to a number of conditions. Specifically, the applicant is required to submit the final results of ongoing clinical studies. SAHPRA also took account of the World Health Organization (WHO) Emergency Use Listing (EUL) report on this vaccine.”
In addition, the conditions require the submission of periodic safety updates in accordance with SAHPRA guidance, and conformance with pharmacovigilance activities as outlined in the approved risk management plan. As outlined in the clinical trial evidence submitted by the applicant, most of the side effects following administration of the CoronaVac vaccine were mild or moderate in nature, and cleared within a couple of days. The frequently-reported adverse reactions were: pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea.
SAHPRA said Curanto Pharma (Pty) Ltd must provide any data or information generated or which otherwise comes into their possession, which is relevant to the risk / benefit profile of the product and/or is relevant to the conditions of use. The company is also obliged to share any such information received from the manufacturers. In particular, any data on the efficacy/effectiveness of the vaccine against disease caused by emerging SARS-CoV-2 variants of concern shall be provided to the regulator.
“A provisional shelf life of 24 months is approved for both the vial and prefilled syringe presentations of the product, for storage at 2 – 8°C and protected from light.”
SAHPRA also announced that:
- It has so far authorised three COVID-19 vaccines: those manufactured by AstraZeneca, Pfizer and Janssen (Johnson & Johnson);
- It has not received applications for the registration of the vaccines manufactured by Moderna or Novavax;
- It has also not received any applications from Cuban manufacturers;
- It is currently reviewing applications for one of the Sinopharm vaccines and for the Sputnik V vaccine, manufactured by the Gamaleya Research Institute.
SAHPRA emphasised that it applies the same criteria to the evaluation of all COVID-19 -vaccine applications, in order to ensure the safety of all South Africans. Every application for registration of a COVID-19 vaccine is evaluated against the same standards of safety, quality and efficacy.
Dr Boitumelo Semete-Makokotlela, SAHPRA Chief Executive Officer, stated: “The medicines’ approval process entails a rigorous process of assessment, where all information provided by the applicant is carefully evaluated by experts in their respective fields. While we have drastically reduced our usual time frames for the registration of COVID-19 vaccines, we have not cut back on the checks required to ensure that they are safe and effective. We will not compromise on the safety of South Africans and we will not endanger South African lives.”
“The Sputnik V application is being processed under a rolling review process, meaning that we are processing their application as we receive the data. This vaccine is also being evaluated under Section 21, which enables us to authorise it for emergency use. SAHPRA has held numerous engagements with the representatives of the two applicants for registration of this vaccine. To date, we have exchanged correspondence on several occasions regarding the data required for their application,” says Semete-Makokotlela.
She points out that according to the regulations, SAHPRA can only evaluate an application that has been submitted by a locally licensed applicant.