Vaccine produces mild or moderate side effects during clinical trials
South Africa
JOHANNESBURG
South Africa’s health regulator announced Monday that it had registered China’s Sinopharm COVID-19 vaccine for use in the country.
The South African Health Products Regulatory Authority (Sahpra) said it authorized use of the vaccine based on acceptable safety, quality and efficacy data submitted to Sahpra over the July 23 to Dec. 22, 2021 period.
“The authorization 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 program,” Sahpra said in a statement.
The vaccine’s manufactures are also required to report 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 vaccine, initially developed by the Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group (CNBG), showed mild or moderate side effects during clinical trials.
According to Sahpra’s statement, the drug will be given in two doses to people aged 18 years and above through intramuscular injection at an interval of two to four weeks, and each dose is 0.5 milliliters.
South Africa, which has the highest number of COVID-19 infections on the African continent at over 3.6 million cases as well as 96,021 fatalities, has fully vaccinated about 42% of its adult population. This translates to roughly 40 million of the country’s 60 million people.
