By Wendell Roelf
CAPE TOWN (Reuters) – South Africa’s medicine regulator said on Thursday it was in an advanced stage of reviewing an emergency application for Pfizer’s COVID-19 vaccine.
“Pfizer has contacted SAHPRA through two regulatory avenues, namely registration for full commercial market access and Article 21 authorization. The Article 21 application is in advanced stages of review,” said Yuven Gounden, spokesperson for the South African Health Products Regulatory Authority. (SAHPRA) said. ), told Reuters.
A Section 21 application, which is normally valid for six months, is a tool for accessing emergency use of an unregistered health product. AstraZeneca’s COVID-19 vaccine was approved by SAHPRA in January.
Gounden added that SAHPRA had received an application for both full market access and Article 21 approval for the Russian Sputnik V vaccine, developed by the Gamaleya Institute.
On Thursday, the European medicine regulator said it had launched an ongoing review of the Sputnik V vaccine, a key confidence in the shot that paves the way for its potential approval in the 27-nation bloc.
South Africa, hit hardest by the African continent’s pandemic in terms of recorded infections and deaths, hopes to receive 117,000 Pfizer doses before the end of the month of the global vaccine distribution scheme COVAX.
These doses would be part of an ‘extraordinary distribution’ granted to the country by COVAX as efforts to accelerate vaccination in Africa.
In the second quarter, South Africa expects to receive more Pfizer doses under a bilateral agreement.
It started rolling out Johnson & Johnson (J&J)’s vaccine last month in a research study on health workers.
J & J’s application for full market access is currently being examined by the regulator, another mechanism to accelerate the approval of COVID-19 vaccines where SAHPRA studies data as it becomes available.
“SAHPRA received the third data package last week and once we have evaluated the fourth data package, the process will be completed,” Gounden added.
(Reporting by Wendell Roelf; editing by Alexander Winning and Emelia Sithole-Matarise)