South Africa's health regulator (South Africa) has registered China's Covid-19 vaccine Sinopharm on Monday( 7/2/2022). This agreement effectively paves the way for use for the country's over-18 adult population.
"This authorization is based on acceptable safety, quality and efficacy data submitted by MC Pharma," the South African Health Products Regulatory Authority (SAHPRA) said in a statement. MC Pharma is a Beijing-based company that manufactures the Sinopharm vaccine.
Two of the most widely used Covid-19 vaccines in China were developed by Sinovac and Sinopharm that proved effective against the SARS-CoV-2 Delta variant. SAHPRA said their authorization for the vaccine was based on data submitted by the company in the second half of last year.
The vaccine will be used in people aged 18 years and over. However, the permit is subject to several conditions, including that the vaccine is supplied and administered two doses by intramuscular injection and must be subject to periodic safety reviews of approximately four weeks.
The South African government has not officially announced a Sinopharm delivery supply or procurement deal. Further conditions relate to the reporting of ongoing study results and conformity with the activities of the pharmakovigilans as outlined in the approved risk management plan, including the submission of periodic security updates.
Vaccine trial results show that side effects are usually mild or moderate and go away within a few days of vaccination. The most common side effects reported were pain at the injection site, headache, fatigue, muscle aches and nausea.
"This vaccine registration is a big step in vaccine registration because Sahpra is playing its part in the fight against Covid-19. Sahpra will continue to play its role in ensuring the quality, safety and efficacy of all health products, including all vaccines, to ensure that South Africans are protected at all times," chief executive Dr Boitumelo Semete-Makokotlela said.
It has fully vaccinated only about 28 percent of its total population of about 60 million. South Africa has relied solely on pfizer and Johnson & Johnson vaccine doses for its inoculations as the country prepares for a potential fifth wave.