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The regulator from South Africa says at an advanced stage of the review of the Pfizer vaccine



From Wendel Roelf

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

“Pfizer is committed to SAHPRA through two regulatory channels, ie registration for full market access and authorization for Section 21. The application for Section 21 is at an advanced stage of review,” said Juven Gundon, spokesman for the South African Health Regulatory Authority. products (SAHPRA), Reuters said.

The application in section 21, usually valid for six months, is an emergency access tool for a health product that is unregistered. AstraZeneca̵

7;s COVID-19 vaccine was approved by Section 21 of SAHPRA in January.

Gundon added that SAHPRA had received an application for both full market access and approval in section 21 for the Russian Sputnik V vaccine, developed by the Gamaleya Institute.

On Thursday, the European medicines regulator said it had begun an ongoing review of the Sputnik V vaccine, an important sign of confidence in the shot, paving the way for its potential approval in the 27-nation bloc.

South Africa, hardest hit by the African continent pandemic in terms of reported infections and deaths, hopes to receive 117,000 doses of Pfizer before the end of the month from the global COVAX vaccine distribution scheme.

These doses would be part of the “exclusive distribution” allocated to the country by COVAX as efforts to increase vaccination in Africa gain momentum.

In the second quarter, South Africa expects to start receiving more doses of Pfizer on a bilateral deal.

She began releasing the Johnson & Johnson (J&J) vaccine last month in a research study aimed at health professionals.

J&J’s application for full market access is currently undergoing a “continuous review” by the regulator, another mechanism for the accelerated approval of COVID-19 vaccines, where SAHPRA examines the data when it becomes available.

“SAHPRA received the third data package last week, and once we evaluate the fourth data package, the process will be completed,” Gundon added.

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


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