SA aims to immunise up to 500,000 health workers in J&J study, scientist says
SA aims to immunise between 350,000 and 500,000 health workers with Johnson & Johnson's Covid-19 vaccine in an “implementation study” to further evaluate the shot, the president of the Medical Research Council said.
Glenda Gray, co-lead investigator on the local leg of a J&J global trial, told Reuters that SA expected to get batches of around 80,000 doses every seven to 14 days for the study, once it is approved.
The implementation study would be aimed at further evaluating J&J's vaccine in the field and would be akin to a phase IIIb study, Gray said. J&J's vaccine has already been tested in the global phase III trial involving more than 40,000 participants including over 6,000 in SA.
Gray's comments come days after the government paused the rollout of 1 million doses of AstraZeneca's vaccine and switched to the J&J shot to start protecting its health workers.
That decision was based on a small clinical trial that showed the AstraZeneca jab provided minimal protection against mild to moderate illness from the more contagious 501Y.V2 virus variant that is now dominant in the country. The government said on Wednesday it was considering selling or swapping AstraZeneca shots it had ordered.
Health Minister Zweli Mkhize said earlier on Wednesday that the J&J implementation study would “provide valuable information about the pandemic in the post-vaccination community and thus, ensure early identification of breakthrough infections should they occur among vaccinated health workers”.
Gray said: “We will get 80,000 (doses) every seven to 14 days and then based on our ability to roll them out we will redeploy them.”
She added that a critical next step was for J&J to get emergency use authorisation (EUA) in the US for its vaccine. The US Food and Drug Administration (FDA) is expected to meet on February 26 to discuss J&J's EUA request.
“Once the FDA has approved it, there's a cascading process that goes to other countries,” Gray said.
“SA has a bilateral agreement with the US FDA and they could accept the EUA from another agency. Alternatively, SA could wait until there is a formal process directly with J&J and (medicines regulator) SAHPRA.”
Minister of health Zweli Mkhize hosted a public briefing on February 10 2021 to address the Oxford-AstraZeneca vaccine's lack of effectiveness against the 501Y.V2 strand of Covid-19. The minister also gave a revised plan of the country's vaccine rollout.
ALL YOU NEED TO KNOW | SA's Covid-19 phase 1 vaccine rollout to start next week with J&J shots