Sahpra: No applications for Sinopharm, Moderna vaccines in SA
The South African Health Products Regulatory Authority (Sahpra) says it still has not received applications for use of the Sinopharm and Moderna vaccines in the country.
Both vaccines are listed for emergency use by the World Health Organisation (WHO).
The global health agency estimates overall vaccine efficacy to be about 78 percent, but not enough trial data is available for adults over the age of 60 years.
Meanwhile, Moderna’s efficacy is categorised at about 86% in people who are 65 and older.
So far, only Pfizer and the Johnson & Johnson vaccines are in use - with more than 2 million doses administered since the roll out in February.
Sahpra CEO Boitumelo Semete-Makokotlela says no other vaccine has met the requirements to get the green light in SA.
“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.”
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Sahpra insists there is not enough data to approve the Russian Sputnik V and Chinese Sinovac vaccines.
“The evaluation of the Coronovac application is at a very advanced stage. Furthermore, reports recently made available by the WHO that articulate the basis for the Emergency Use Listing are being considered,” says Semete-Makokotlela.
“The Sputnik V application is a rolling review, thus as data becomes available to the applicant it is submitted to SAHPRA.”
Semete-Makokotlela adds the regulatory body will not be pressured into rash decisions.
“Sahpra is committed to prioritising all Covid-19- related health products, including vaccines, as the world and South Africa grapples with ending the scourge of a pandemic of mammoth proportions.”
