South Africa’s drugs regulator, South African Health Products Regulatory Authority (SAHPRA) has given a go-ahead to the implementation study of Johnson & Johnson’s COVID-19 vaccine, thus making way for the first inoculation of the vaccines amongst the health workers.
According to Reuter news report, “SAHPRA has approved the implementation study.
“’The implementation study, similar to the final phase of a vaccine trial, will test the effects of the vaccine in the field after it is administered to around 350,000 to 500,000 health care workers”.
What you should know
- South Africa is currently the hardest-hit African country and accounts for over a third of the continent’s infections and almost half of the deaths, led primarily by the new, more contagious variant called 501Y.V2.
- As South Africa is yet to commence its COVID-19 vaccination programme based on the less potency of AstraZeneca’s two-shot vaccine, its government has resolved to go ahead with the J&J dose.
- According to President Cyril Ramaphosa, the first batch of J&J’s 80,000 doses is expected to arrive South Africa shortly.
- J&J was the first pharmaceutical major to apply to the local regulator in December to register its COVID-19 vaccine, although Pfizer and AstraZeneca have also applied.
- According to the South African Health Products Regulatory Authority (SAHPRA), J&J has not yet submitted a special domestic application for emergency use authorisation of its vaccine – known as a Section 21 application.