The SA Health Products Regulatory Authority (Sahpra) has announced the authorisation of Pfizer’s Comirnaty vaccine and the Covid-19 vaccine MC Pharma, also known as Sinopharm/BIBP vaccine, for use in SA. 

According to the regulatory authority, the approval of the two vaccines is based on acceptable safety, quality and efficacy data submitted by the companies.

Both vaccines have been registered in terms of section 15 of the Medicines and Related Substance Act, with conditions.

“The registration of these vaccines is a vast stride in vaccine registration as Sahpra plays its role in the fight against Covid-19,” said Sahpra CEO Dr Boitumelo Semete-Makokotlela.

“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.”

Comirnaty vaccine

Comirnaty is an mRNA vaccine indicated for active immunisation to prevent Covid-19 in individuals 12 years of age and older. 

The vaccine is administered intramuscularly after dilution as a course of two doses and 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 to Sahpra as a rolling submission over the period February 3 2021 to January 17 2022.

“The authorisation is, however, 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,” Sahpra said.

What are the adverse effects to look out for? 

Sahpra said the adverse effects of the vaccine are 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,” said Sahpra. 

MC Pharma

MC Pharma is an inactivated vero cell vaccine, indicated for immunisation against Sars-CoV-2 in individuals aged 18 years and older. 

The vaccine is administered as two doses by intramuscular injection at an interval of two to four weeks and each dose is 0.5ml.

“This authorisation is based on acceptable safety, quality and efficacy data submitted by MC Pharma to Sahpra as a rolling submission over the period July 23 to December 22 2021,” said the regulatory body. 

“The authorisation is, however, subject to a number of conditions which include 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.”

What are the adverse effects to look out for? 

The adverse effects of MC Pharma are 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,” said Sahpra.