THE SA Health Products Regulatory Authority (Sahpra) has stuck to its guns ahead of an anticipated march led by the EFF to demand the inclusion of the Russian Sputnik V and Chinese Sinovac vaccines for use.
The party claimed that Sahpra was disallowing the usage of Sputnik V and Sinovac vaccines because it was micromanaged and controlled by Western countries’ pharmaceutical companies which work with local collaborators to prevent the authorisation of vaccines from China and Russia.
But Saphra chief executive Dr Boitumelo Semete-Makokotlela said they were committed to prioritising all Covid-19-related health products, including vaccines.
In an effort to respond to the pandemic, the organisation said it introduced a mechanism to facilitate a review of Covid applications, which is the rolling review process.
This mechanism facilitates the submission of data as it becomes available. While reviews can start 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, said Saphra.
“Sahpra will not be pressured to allow the public access to any product that has not met the necessary regulatory requirements,” Semete-Makokotlela said.
The applications for Coronavac (manufactured by Sinovac) were at a very “advanced stage”.
“Furthermore, reports recently made available by the World Health Organization (WHO) that articulate the basis for the Emergency Use Listing are being considered. The Sputnik V application is a rolling review, thus as data becomes available to the applicant it is submitted to Sahpra.
“Sahpra cannot approve any product if an application has not been submitted to the authority. Thus, there is no Sahpra decision on Sinopharm and Moderna vaccines which have a WHO Emergency Use Listing, as there have not been any applications for these vaccines in South Africa,” Semete-Makokotlela said.
The organisation has raised the issue of the prevalence of variants of concern such as the beta variant in South Africa, saying this required that Saphra ensure efficacy against such variants and hence information on studies supporting efficacy would be expected to be provided by the applicant.
Cape Times