Coronavac application at advanced stage, no decision on Sinopharm, Moderna – SAHPRA
This article has been supplied.
The South African Health Products Regulatory Authority (SAHPRA) stressed on Monday that it could not approve any vaccines if an application is not submitted to the authority, as South Africa trails in its roll-out of Covid-19 vaccines.
However, the SAHPRA revealed that applications had been received for the Sputnik V and Sinovac’s Coronavac vaccines and that the evaluation of the Coronavac application is at an advanced stage.
The Sputnik V application is a rolling review, which the SAHPRA says is a mechanism that facilitates the submission of data as it becomes available.
“Whilst reviews can commence earlier with a rolling submission, it is important to note that some very important efficacy, quality and safety information is sometimes outstanding and would require review for consideration of such products for public use. Therefore, pharmaceutical companies can submit applications indicating a plan of when they will be submitting their data, i.e. outline when the next rolling submission sequence is available for review,” the authority explains.
SAHPRA has not made a decision on the Sinopharm and Moderna vaccines, which have a World Health Organization (WHO) Emergency Use Listing, as there have not been any applications for these vaccines in South Africa, the authority said.
SAHPRA has so far approved the Pfizer and the Johnson & Johnson vaccines for use in the country.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the regulatory body would not be pressured to allow the public access to any product that had not met the necessary regulatory requirements.
The SAHPRA is concerned about the prevalence of other Covid-19 variants in South Africa, and is urging pharmaceutical companies to provide information on studies supporting efficacy with their vaccine applications.
Article Enquiry
Email Article
Save Article
Feedback
To advertise email advertising@creamermedia.co.za or click here
Announcements
What's On
Subscribe to improve your user experience...
Option 1 (equivalent of R125 a month):
Receive a weekly copy of Creamer Media's Engineering News & Mining Weekly magazine
(print copy for those in South Africa and e-magazine for those outside of South Africa)
Receive daily email newsletters
Access to full search results
Access archive of magazine back copies
Access to Projects in Progress
Access to ONE Research Report of your choice in PDF format
Option 2 (equivalent of R375 a month):
All benefits from Option 1
PLUS
Access to Creamer Media's Research Channel Africa for ALL Research Reports, in PDF format, on various industrial and mining sectors
including Electricity; Water; Energy Transition; Hydrogen; Roads, Rail and Ports; Coal; Gold; Platinum; Battery Metals; etc.
Already a subscriber?
Forgotten your password?
Receive weekly copy of Creamer Media's Engineering News & Mining Weekly magazine (print copy for those in South Africa and e-magazine for those outside of South Africa)
➕
Recieve daily email newsletters
➕
Access to full search results
➕
Access archive of magazine back copies
➕
Access to Projects in Progress
➕
Access to ONE Research Report of your choice in PDF format
RESEARCH CHANNEL AFRICA
R4500 (equivalent of R375 a month)
SUBSCRIBEAll benefits from Option 1
➕
Access to Creamer Media's Research Channel Africa for ALL Research Reports on various industrial and mining sectors, in PDF format, including on:
Electricity
➕
Water
➕
Energy Transition
➕
Hydrogen
➕
Roads, Rail and Ports
➕
Coal
➕
Gold
➕
Platinum
➕
Battery Metals
➕
etc.
Receive all benefits from Option 1 or Option 2 delivered to numerous people at your company
➕
Multiple User names and Passwords for simultaneous log-ins
➕
Intranet integration access to all in your organisation

















