South Africa’s regulator says it is in an advanced stage of Pfizer’s vaccine review

By Wendell Roelf

CAPE TOWN (Reuters) – South Africa’s drug regulator said Thursday that it was in an advanced stage of reviewing an emergency use request for Pfizer’s COVID-19 vaccine.

“Pfizer has engaged with SAHPRA through two regulatory avenues, namely, registration for full commercial market access and Section 21 authorization. The Section 21 application is in advanced stages of review,” Yuven Gounden, a spokesman for the South African Healthcare Products Regulatory Authority (SAHPRA), told Reuters.

A Section 21 application, normally valid for six months, is a tool for emergency use access of a health product that is not registered. AstraZeneca’s COVID-19 vaccine received SAHPRA Section 21 approval 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, the European drug regulator said it had begun an ongoing review of the Sputnik V vaccine, a major show of confidence in the injection that paves the way for possible approval in the 27-nation bloc.

South Africa, the country most affected by the pandemic on the African continent in terms of registered infections and deaths, expects to receive 117,000 doses of Pfizer before the end of the month of the global COVAX vaccine distribution plan.

Those doses would be part of an “exceptional distribution” assigned to the country by COVAX as efforts to increase vaccination in Africa increase.

In the second quarter, South Africa expects to start receiving more doses from Pfizer under a bilateral agreement.

It began implementing the Johnson & Johnson (J&J) vaccine last month in a research study targeting healthcare workers.

J & J’s request for full market access is currently under “ongoing 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 packet last week and once we have evaluated the fourth data packet, the process will be complete,” Gounden added.

(Reporting by Wendell Roelf; Editing by Alexander Winning and Emelia Sithole-Matarise)

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