South Africa has secured 20 million doses of the vaccine that are expected in the country at the end of next month.
SAHPRA says in a statement that the approval is subject to further efficacy and safety surveillance of the vaccine in South Africa, including against the dominant 501.V2 variant that was discovered in the country last year.
Pfizer-BioNTech COVID-19 vaccine’s efficacy is reduced against the 501Y.V2 variant: Study
A Section 21 application is normally valid for six months and is an instrument for emergency use access to a health product that is unregistered.
AstraZeneca’s COVID-19 vaccine that was bought by South Africa from the Serum Institute in India and later suspended due to efficacy concerns was granted Section 21 approval by SAHPRA in January.
Pfizer-BioNTech efficacy against new COVID-19 variants: Prof. Pei-Yong Shi