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.
The study had certain limitations. Samples were collected from the study subjects only at a single time point of six weeks post-vaccination, which prevented the possibility of exploring antibody or immunity decay.
Though the VIDAS diagnostic test was reported to have a sensitivity of 88.3% and specificity of 98.4%, there is a possibility that it may not have accurately estimated the antibody titers. The test reliability may also be compromised due to cross-reactivity between the SARS-CoV-2-specific antibodies and endemic coronaviruses.The present study compared the efficiency of the Pfizer-BioNTech mRNA vaccine to a classic vaccine Sinopharm. In diagnostic assays, the Pfizer BioNTech elicited high IgG titers levels when compared to Sinopharm.
Furthermore, the multivariate analysis showed that the Pfizer vaccine had a positive effect on IgG positivity. High antibody IgG titer levels are associated with higher and long-lasting immunity. Taken together, the findings from this study show that the Pfizer BioNTech vaccine may provide better protection against COVID-19 when compared to Sinopharm. the presence of cardiovascular diseases was found to have a significant negative correlation with IgG titers levels after vaccination, thereby suggesting that this patient population may need special attention.
Further studies are required to confirm if booster doses are needed for individuals who have already received Sinopharm and those with specific conditions who did not exhibit IgG titer positivity after vaccination.