Johannesburg - A decision on the Sinovac Covid-19 vaccine will be made in the next few days, said the South African Health Products Regulatory Authority (Sahpra).
The regulatory body hosted a media briefing on Thursday where the status of the registration of Covid-19 vaccines in South Africa was outlined.
Sahpra chief executive Dr Boitumelo Semete-Makokotlela said the regulatory authority was in an advanced stage of evaluation of China’s Sinovac vaccine.
“There should be a decision that is communicated to the applicant in the next few days,” Semete-Makokotlela said.
She said Sahpra could get multiple applications for each vaccine and every application had to be reviewed.
Semete-Makokotlela added that the process to authorise a vaccine takes about 20 months, but this time has been reduced to about three months because of the pandemic.
“This means we are working tirelessly, over weekends and public holidays, all hands on deck to ensure we don’t have any delay.”
She added that the quality of the submission also determined the timeline.
Sahpra was also working with the applicants of Russia’s Sputnik V vaccine and they applied for an emergency use application as well as a rolling review submission, where they make data available as they receive it, said SemeteMakokotlela.
“We have to make sure that when or if we authorise this vaccine, we are comfortable that the clinical data is adequate.”
Sahpra senior manager for pharmaceutical evaluation, Silverani Padayachee, added that they had requested additional information from the Sputnik V vaccine applicants and that some of this information was scheduled to be available later based on the applicants’ rolling submission plan.
“There have been in the last week three submissions with the latest being on June 28, which is now being reviewed and will bring us closer to regulatory decision,” Padayachee said.
Regarding transparency, Andy Gray, who sits on Sahpra’s legal committee, said South Africa’s legislation was somewhat old fashioned in that there is a clause that uses the word “secrecy”.
“It has been interpreted in the past as meaning that everything that happens within the regulator is confidential, including the fact that an application has been submitted for registrations of medicine,” he said.
Gray said Sahpra was shifting to greater transparency and planned in time to issue a public assessment report.
The Star