The chairperson of the South African Health Products Regulatory Authority (SAHPRA), Professor Helen Rees says they’re still waiting on more information about the Sputnik V vaccine to properly review it.
There have been questions why the vaccine has not been brought into the country, as the EFF pickets at SAHPRA’s offices to demand the Sputnik V and Sinovac vaccines be part of the vaccine rollout in South Africa.
The EFF will picket at the SAHPRA offices to demand the Sputnik V and Sinovac Vaccine to be part of the vaccines that are rollout in South Africa.
— Economic Freedom Fighters (@EFFSouthAfrica) June 17, 2021
So far the only vaccines that have been approved by SAHPRA for emergency use are the AstraZeneca, Pfizer and J&J vaccines.
The vaccines SAHPRA has in the pipeline are Sputnik from Russia and Sinovac from China.
“It’s not taking a long time to review Sputnik. There were two applicants and what they’re doing is called a rolling review. As they get data, they submit it to SAHPRA and we’re reviewing that data on a continuous basis,” Rees said.
“This speeds things up because we’re not getting a huge file of information that the regulator has to suddenly try and evaluate. They’re still submitting some of that data, so we don’t have all the data that’s required for a complete review yet.”
“What we have to do in case of the vaccines is to ensure they’re safe, of good quality and manufactured properly so that by the time they arrive in the country they still have a very good standard and they’re effective. We look at the clinical trial data that’s presented to us.
“The drug regulator doesn’t do trials itself, we depend on academics and researchers and the pharmaceutical industry that’s developing some of them. We depend on them to generate data which they then put into a dossier and present to us.
“They present a lot of information about every single thing that happened in the laboratory, clinical assessments and manufacturing process and how they intend to monitor the safety of the vaccine.”
Rees said other vaccines, including the Cuban vaccines, are not being reviewed by the health regulator because no one has applied for them to be reviewed.
“SAHPRA doesn’t go out and look for vaccines. Local applicants approach the regulator with an application. From the onset, SAHPRA has to prioritise the evaluation of Covid-19 vaccines,” she said.
“Other vaccines that people have been asking about are not under review because we don’t have an application for them, including the Cuban vaccine we’ve been hearing a lot about.”
Rees said none of the vaccines used in the country are 100% effective against the Beta variant circulating in South Africa.
“They were all developed for the initial variant that came from Wuhan,” she said.