Pretoria – The Chinese Embassy in Pretoria has welcomed the South African Health Products Regulatory Authority’s (Sahpra) registration of the Sinopharm Covid-19 vaccine for use in adults within South Africa.
The vaccine is manufactured by the Beijing Institute of Biological Products Co. Ltd, which is also referred to as the Sinopharm Vaccine of China.
“The Chinese Embassy in South Africa welcomes this latest, positive development which paves the way for the Chinese-made vaccine's use in South Africa. We appreciate and honour concerted efforts made by the international community, since major progress has been made in the global fight against the Covid-19 pandemic,” the diplomatic mission said on Wednesday.
“The pandemic is proving to be a protracted one, resurging with more variants and spreading faster than before. It poses a serious threat to the safety of people around the world.”
The embassy pledged that Beijing would continue working closely with South Africa, particularly in the fight against the Covid-19 pandemic.
“The Chinese Embassy in South Africa will actively follow through on the solemn commitment of President Xi Jinping in making Chinese Covid-19 vaccines a global public good. We will continue to fully assist people in South Africa and other African countries in the fight and eventual defeat of the virus,” the embassy said.
Sahpra has also registered the Comirnaty vaccine by Pfizer Laboratories for use in South Africa in addition to the Sinopharm vaccine.
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 were 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 by MC Pharma
MC Pharma is a Beijing 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 its application to Sahpra over the period of July 23, 2021, to December 22, 2021. It was approved on January 31 this year.
The MC Pharma vaccine is an inactivated Vero Cell vaccine available to those aged 18 years and older. It requires two doses administered two to four 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 was based on acceptable data submitted by Pfizer Laboratories as a rolling submission over the period of February 3, 2021, to January 17, 2022. The vaccine was registered on January 25.
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 include that the vaccine is supplied and administered in accordance with the National Covid-19 vaccination programme and applicable guidelines.
IOL