J&J's vaccine implementation study in S.Africa gets regulator nod

CAPE TOWN: South Africa's drugs regulator said on Monday it had approved an implementation study of Johnson & Johnson's COVID-19 vaccine, clearing the way to start the country's first inoculations among frontline health workers.

South Africa has yet to launch 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, adding it was still reviewing its separate application for full market use.

The 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 350,000-500,000 health care workers.

The first batch of J&J's 80,000 doses is expected to arrive this week, President Cyril Ramaphosa told lawmakers on Thursday.

J&J was the first pharmaceutical major to apply to SAHPRA in December to register its COVID-19 vaccine; Pfizer and AstraZeneca have also since applied.

South Africa is the African country hardest hit by the coronavirus, accounting 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.

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.

Last week, the co-lead for the local leg of J&J's vaccine trial, Glenda Gray, said that J&J had made a rolling submission to the regulator and its application was "being processed for emergency use."

Gray clarified on Monday that J&J had applied for "early access" - essentially seeking approval to use its vaccine for the implementation study. This differs from an emergency use authorisation (EUA) approval, which the company has not yet applied for, she said.

J&J did not immediately respond to an email requesting further details. SAHPRA said it was also processing J&J's application for full market registration as part of a rolling review approach, which allows data to be evaluated by SAHPRA as it becomes available.

The rolling review is one of several methods the domestic regulator is pursuing to help fast-track vaccine approvals.