CAPE TOWN - The South African Health Products Regulatory Authority (Sahpra) has announced the registration of two new Covid-19 vaccines: the Comirnaty vaccine by Pfizer Laboratories and MC Pharma by MC Pharma.
Comirnaty was approved on January 25 for active immunisation to prevent Covid-19 in individuals 12 years of age and older while MC Pharma was approved on January 31 for those aged 18 years and older.
Both have been registered under section 15 of the Medicines and Related Substance Act (Act 101 of 1965 as Amended), with conditions.
Comirnaty is administered intramuscularly after dilution as a course of two doses. 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 (Pty) Ltd to Sahpra as a rolling submission over the period February 3 2021 to January17, 2022. 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,” Sahpra said.
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 Comirnaty vaccine were 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, an inflammatory disease of the heart muscle, and pericarditis, an inflammatory disease of the lining of the heart muscle, have been observed following vaccination.
The MC Pharma vaccine is an inactivated Vero Cell vaccine, 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.
MC Pharma is administered as two doses by intramuscular injection at an interval of 2 to 4 weeks.
“This authorisation is based on acceptable safety, quality and efficacy data submitted by MC Pharma Pty (Ltd) to Sahpra as a rolling submission over the period 23 July 2021 to 22 December 2021. The authorisation is subject to a number of conditions which includes that the vaccine is supplied and administered in accordance with the National Cvoid-19 vaccination programme,” Sahpra said.
The most common adverse effects reported for this vaccine was pain at the injection site, headache, tiredness, muscle pain and nausea.
“The registration of these vaccines is a vast stride in vaccine registration as Sahpra plays its role in the fight against Covid-19,” chief executive Dr Boitumelo Semete- Makokotlela said.
“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.”
Cape Times