The SA Health Products Regulatory Authority (SAHPRA) has registered Chinese COVID-19 vaccine Sinopharm, effectively clearing the way for its use in the country.
In a statement, SAHPRA said the authorisation was “based on acceptable safety, quality and efficacy data submitted by MC Pharma”, the latter being the Beijing-based company that manufactures Sinopharm vaccine.
SAHPRA also said it was still also evaluating a number of applications for emergency use of COVID-19 vaccines.
South Africa, which is the worst-hit country in Africa both in terms of COVID fatalities and caseload, has relied mainly on Pfizer and J&J vaccine doses as its inoculation mainstay as the country prepares for a potential fifth wave, reports Moneyweb.
China’s two most widely used COVID-19 vaccines, Sinovac and Sinopharm, were shown to be effective against the Delta variant of the coronavirus, a study based on real-world data in the country showed in February.
SAHPRA said their authorisation for the vaccine, to be used on people 18 years and above, was based on data submitted by the company in the latter half of last year.
However, the authorisation was subject to several conditions, including that the vaccine supplied and administered as two injection shots, must be subject to periodic safety reviews.
The government has not officially announced a supply deal or procurement of shipments of Sinopharm as yet. Thus far, only about 28% of the total population of roughly 60m people in the country have been fully vaccinated.
Study details
Effectiveness of Inactivated COVID-19 Vaccines Against Illness Caused by the B.1.617.2 (Delta) Variant During an Outbreak in Guangdong, China
Min Kang, Yao Yi, Yan Li, Limei Sun, Aiping Deng, Ting Hu, Jiayi Zhang, Jun Liu, Mingji Cheng, Shen Xie, Min Luo, Jing Jiang, Yawen Jiang, Shixing Tang, Jianfeng He.
Published in the Annals of Modern Medicine on 1 February 2022
Abstract
Background
Real-world evidence on inactivated COVID-19 vaccines against the highly transmissible B.1.617.2 (Delta) variant of SARS-CoV-2 is limited, leaving an important gap in the evidence base about inactivated COVID-19 vaccines for use by immunisation programmes.
Objective
To estimate inactivated vaccine effectiveness (VE) against the B.1.617.2 variant.
Design
Retrospective cohort study.
Setting
The study was based on the first outbreak of the B.1.617.2 variant in mainland China that was discovered and traced in Guangdong in May and June 2021.
Participants
10,805 adult case patients with laboratory-confirmed infection and close contacts.
Measurements
Participants were categorised as unvaccinated, partially vaccinated (1 dose), and fully vaccinated (2 doses). We estimated VE against the primary outcome of pneumonia and the secondary outcomes of infections, symptomatic infections, and severe or critical illness associated with the B.1.617.2 variant.
Results
Results are reported in the order of outcome severity. Of 10,805 participants, 1.3% contracted infections, 1.2% developed symptomatic infections, 1.1% had pneumonia, and 0.2% had severe or critical illness. The adjusted VEs of full vaccination were 51.8% (95% CI, 20.3% to 83.2%) against infection, 60.4% (CI, 31.8% to 88.9%) against symptomatic infection, and 78.4% (CI, 56.9% to 99.9%) against pneumonia. Also, full vaccination was 100% (CI, 98.4% to 100.0%) effective against severe or critical illness. By contrast, the adjusted VEs of partial vaccination against infection, symptomatic infection, and pneumonia were 10.7% (CI, −41.2% to 62.6%), 6.8% (CI, −47.4% to 61.0%), and 11.6% (CI, −42.6% to 65.8%), respectively.
Limitation
Observational study with possible unmeasured confounders; insufficient data to do reliable subgroup analyses by age and vaccine brand.
Conclusion
Full vaccination with inactivated vaccines is effective against the B.1.617.2 variant. Effort should be made to ensure full vaccination of target populations.
Moneyweb article – SAHPRA registers Sinopharm Covid vaccine (Open access)
SAHPRA REGISTERS TWO COVID-19 VACCINES (Open access)
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