Cape Town – The South African Health Products Regulatory Authority (Sahpra) has approved two more Pfizer vaccines for use in South Africa.
The recently approved Pfizer vaccines include the Comirnaty Ready To Use (RTU) Adult Vaccine, and the Dilute To Use (DTU) Paediatric Vaccine.
This approval comes at a time when the country is experiencing low Covid-19 infection rates.
Sahpra CEO, Boitumelo Semete-Makokotlela, said authorisation of these vaccines was based on acceptable safety, quality and efficacy data submitted by Pfizer Laboratories to SAHPRA as a full submission.
“The authorisation is, however, subject to a number of conditions, which include that the vaccine is supplied and administered in accordance with the National Covid-19 vaccination programme and applicable guidelines.
“Further conditions relate to the reporting of the results of ongoing monitoring and conformance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates,” Semete-Makokotlela added.
Semete-Makokotlela stressed that Comirnaty Ready To Use (RTU) Adult Vaccine was for severely immuno-compromised individuals aged 12 years and older. A third primary course dose may be administered intramuscularly at least 28 days after the second dose.
She further added that the Dilute To Use (DTU) Paediatric Vaccine was for severely immunocompromised individuals aged five years and older. A third primary course dose may be administered intramuscularly at least 28 days after the second.
Meanwhile, speaking to Newzroom Afrika, Vaccines for Africa Initiative’s (VACFA) co-director, Professor Benjamin Kagina, said that when the Covid-19 pandemic started, there was a general consensus that the disease wasn’t affecting children as much.
However, subsequent data had shown that even the paediatric population was experiencing a quite significant challenge when it came to Covid-19 vaccines.