(Adds detail on Sputnik V, J&J vaccines)
By Wendell Roelf
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.
Gounden added that SAHPRA had received an application for
both full market access and Section 21 approval for Russia's
Sputnik V vaccine, developed by the Gamaleya Institute.
On Thursday, Europe's medicines regulator said it had
started a rolling review of the Sputnik V vaccine, an important
display of confidence in the shot that paves the way for its
potential approval across the 27-nation bloc.
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.
J&J's application for full market access is currently under
a "rolling review" by the regulator, another mechanism to
fast-track approval of COVID-19 vaccines where SAHPRA studies
data as they become available.
"SAHPRA received the third data pack last week and once we
have evaluated the fourth data pack, the process will be
completed," Gounden added.
(Reporting by Wendell Roelf;
Editing by Alexander Winning and Emelia Sithole-Matarise)
Astrazeneca (AZN)
