he South African Health Products Regulatory Authority (Sahpra) has registered the Chinese-made Sinopharm Covid vaccine for use in adults over the age of 18 in South Africa.
The vaccine is administered in two doses by intramuscular injection at an interval of two to four weeks, the regulator said on a statement on Monday morning (7 February).
Sahpra said final authorisation 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.
Further conditions relating 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, it said.
Trial results of the vaccine show that adverse effects 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 nausea.
“The registration of these vaccines is a vast stride in vaccine registration as Sahpra plays its role in the fight against Covid-19. 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,” said chief executive Dr Boitumelo Semete- Makokotlela.
Original story on BusinessTech