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S.Africa regulator says at advanced stage of Pfizer vaccine review

CAPE TOWN (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.

A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Pfizer logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic/File Photo

“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.

South Africa has also secured 20 million shots from Pfizer and “our anticipation was that the first amount of 600,000 would arrive here before the end of March and between 5 and 7 million should arrive in April to June,” the country’s Health Minister Zweli Mkhize said in a separate briefing.

It still needs to sign the first agreement and then confirm the second one, he added.

South Africa 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.

Additiional reporting by Nqobile Dludla; Editing by Alexander Winning, Aurora Ellis and Emelia Sithole-Matarise

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