A health worker prepares a dose of Chinese-made Sinopharm Covid-19 vaccine. Photo by Andrej ISAKOVIC / AFP)
The South African Health Products Regulatory Authority (Sahpra) has registered two additional Covid-19 vaccines, the Comirnaty vaccine by Pfizer Laboratories and Sinopharm by MC Pharma.
In a press release on Monday, the health regulator said that both vaccines had been registered in terms of section 15 of the Medicines and Related Substance Act with conditions.
Sahpra CEO, Dr Boitumelo Semete-Makokotlela, said the authorisations are based on acceptable safety, quality and efficacy data submitted.
“The registration of these vaccines is a vast stride in vaccine registration as Sahpra plays its role in the fight against Covid-19,” she said.
Here’s a breakdown of the two vaccines:
Covid-19 vaccine MC Pharma
MC Pharma is a Beijing-based company that manufactures Sinopharm vaccines. While the vaccine is known globally as Sinopharm, in South Africa, it will be referred to as MC Pharma.
The company first submitted their application to Sahpra over the period of 23 July 2021 to 22 December 2021. It was approved on 31 January 2022.
The MC Pharma vaccine is an inactivated Vero Cell vaccine available to those aged 18 years and older. It requires two doses administered 2-4 weeks apart.
According to the World Health Organization (WHO), results from a study found vaccine efficacy against hospitalisation was 79%.
“A large multi-country Phase 3 trial has shown that two doses, administered at an interval of 21 days, have an efficacy of 79% against symptomatic Sars-CoV-2 infection 14 or more days after the second dose.”
Sahpra said adverse effects of the vaccine, as outlined in the clinical trial by MC Pharma, were usually mild or moderate. The most common adverse effects reported were pain at the injection site, headache, tiredness, muscle pain and nausea.
Comirnaty vaccine
This mRNA vaccine, produced by Pfizer Laboratories, is a two-dose vaccine administered three weeks after the initial dose.
Sahpra said the authorisation is based on acceptable data submitted by Pfizer Laboratories as a rolling submission over the period 3 February 2021 to 17 January 2022. The vaccine was registered on 25 January.
The Comirnaty vaccine can be administered to individuals 12 years of age and older.
The WHO said results from a clinical trial found vaccine efficacy to be 95%.
“Efficacy shown in clinical trials in participants with or without evidence of prior infection with Sars-CoV-2 and who received the full series of vaccine (two doses) was approximately 95% based on a median follow-up of two months.”
Sahpra said 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,” said the health regulator.
The authorisation of both vaccines is 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.
Media Release: SAHPRA registers two COVID-19 vaccines [Follow thread]
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