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CAPE TOWN, March 4 (Reuters) - South Africa's medicines
regulator said on Thursday that it was at an advanced stage of
reviewing an emergency use application for Pfizer's
COVID-19 vaccine.
"Pfizer has engaged with SAHPRA via two regulatory pathways,
that is registration for full commercial market access and
Section 21 authorisation. The Section 21 application is in
advanced stages of review," Yuven Gounden, spokesman for the
South African Health Products Regulatory Authority (SAHPRA),
told Reuters.
A Section 21 application, normally valid for six months, is
an instrument for emergency use access of a health product that
is unregistered. AstraZeneca's COVID-19 vaccine was
granted Section 21 approval by SAHPRA in January.
South Africa, the hardest-hit by the pandemic on the African
continent in terms of recorded infections and deaths, hopes to
receive 117,000 Pfizer doses before the end of the month from
global vaccine distribution scheme COVAX.
Those doses would be part of an "exceptional distribution"
allocated to the country by COVAX as efforts to ramp up
vaccination across Africa gather pace.
In the second quarter South Africa expects to start
receiving more Pfizer doses under a bilateral deal.
It started rolling out Johnson & Johnson's (J&J)
vaccine last month in a research study targeting healthcare
workers.
(Reporting by Wendell Roelf;
Editing by Alexander Winning and Emelia Sithole-Matarise)
Astrazeneca (AZN)
