By Wendell Roelf
CAPE TOWN (Reuters) – South Africa’s drug regulator said on Thursday that it was in an advanced stage of reviewing an emergency use request for Pfizer’s COVID-19 vaccine.
“Pfizer has committed to SAHPRA through two regulatory channels, that is, registration for full access to the commercial market and the authorization of Section 21. The application of Section 21 is in advanced stages of review,” Yuven Gounden, port of the South African Health Products Regulatory Authority (SAHPRA), he told Reuters.
An application of Section 21, normally valid for six months, is an instrument for accessing emergency use of a health product that is not registered. AstraZeneca’s COVID-19 vaccine obtained SAHPRA Section 21 approval in January.
Gounden added that SAHPRA has received a request for full market access and Section 21 approval for Russia’s Sputnik V vaccine, developed by the Gamaleya Institute.
On Thursday, Europe’s drug regulator said it began a continuous review of the Sputnik V vaccine, an important demonstration of confidence in the injection that paves the way for its potential approval across the 27-nation bloc.
South Africa, the region most affected by the pandemic on the African continent in terms of infections and reported deaths, expects to receive 117,000 doses of Pfizer before the end of the month of the global distribution scheme for the COVAX vaccine.
These doses would be part of a “exceptional distribution” allocated to the country by COVAX as efforts to increase vaccination across Africa gain momentum.
In the second quarter, South Africa expects to start receiving more doses of Pfizer in a bilateral agreement.
She started launching the Johnson & Johnson (J&J) vaccine last month in a research study aimed at healthcare professionals.
J&J’s request for full market access is currently under “continuous review” by the regulator, another mechanism to accelerate the approval of COVID-19 vaccines where SAHPRA studies the data as it becomes available.
“SAHPRA received the third data package last week and as soon as we evaluate the fourth data package, the process will be completed,” added Gounden.
(Reporting by Wendell Roelf; Editing by Alexander Winning and Emelia Sithole-Matarise)