SA regulator says Pfizer vaccine review is at an advanced stage

SA'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.

“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, spokesperson 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.

SA, 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.

In the second quarter SA expects to start receiving more Pfizer doses under a bilateral deal.

It started rolling out Johnson & Johnson's (J & ) vaccine last month in a research study targeting health-care workers.

J & 's application for full market access is now 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.