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By Wendell Roelf
CAPE TOWN, Feb 10 (Reuters) - South Africa 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 country's
Medical Research Council said.
Glenda Gray, co-lead investigator on the local leg of a J&J
global trial, told Reuters South Africa 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 South Africa.
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 amongst vaccinated health workers".
Gray said: "We will get 80,000 (doses) every 7 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 United States for its
vaccine. The U.S. Food and Drug Administration (FDA) is expected
to meet on Feb. 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.
"South Africa has a bilateral agreement with the U.S. FDA
and they could accept the EUA from another agency.
Alternatively, South Africa could wait until there is a formal
process directly with J&J and (medicines regulator) SAHPRA."
(Reporting by Wendell Roelf; Editing by Alexander Winning and
Alison Williams)
