J&J's Vaccine Implementation Study In S.Africa Gets Regulator Nod
South Africa's drugs regulator SAHPRA said on Monday it has approved an implementation study of Johnson & Johnson's COVID-19 vaccine, clearing the way to start the country's first inoculations amo...
South Africa's drugs regulator SAHPRA said on Monday it has approved an implementation study of Johnson & Johnson's COVID-19 vaccine, clearing the way to start the country's first inoculations among health workers.
South Africa is yet to start its COVID-19 vaccination programme and the government has decided to go with the J&J dose after trial results this month showed AstraZeneca's two-shot vaccine was less effective against the new variant of the coronavirus dominating South African infections.
"SAHPRA has approved the implementation study," the regulator said in response to Reuters questions, but added it was still reviewing its separate full market application.
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.
The first batch of J&J's 80,000 doses are expected to arrive this week, President Cyril Ramaphosa told lawmakers on Thursday.
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.
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.
The South African Health Products Regulatory Authority (SAHPRA) said J&J has not yet submitted a special domestic application for emergency use authorisation of its vaccine - known as a Section 21 application.
Normally valid for six months, Section 21 authorisation allows emergency use of a product that is unregistered, SAHPRA officials said.
However, J&J's application for full market registration was being processed as part of a rolling review approach, which allows data to be evaluated by SAHPRA as it becomes available, the regulator said. "The rolling review has received its second batch of data and is under review. The full process is estimated to be complete after four batches of rolling data (are received)," said SAHPRA.
This is one of several methods the domestic regulator is pursuing to help fast-track vaccine approvals.