Cape Town - Children aged 12 and older in SA have been approved to be vaccinated against Covid-19, but for now they will only be receiving the Pfizer vaccine, and SA Health Products Regulatory Authority (Sahpra) chief executive has explained why.
The news came during the Western Cape’s regular digital news conference to update citizens on the health platform and vaccination programme across the province at which Sahpra’s chairperson Professor Helen Rees and Sahpra chief executive Dr Boitumelo Semete-Makokotlela were special guests.
Health MEC Nomafrench Mbombo hosted the digicon as Premier Alan Winde is attending the three-day Cabinet lekgotla that began on Tuesday.
Semete-Makokotlela explained that part of their role at Sahpra is evaluating pre-clinical data to ensure that the vaccine trial meets all regulatory requirements for vaccines, and assessing clinical trials in terms of safety data and providing evidence of the vaccine’s ability to prevent Covid-19.
When it comes to determining which vaccines that the newly-approved age cohort can use, they have to consider the data that they are given.
“For us again, if we don’t receive data that speaks to the vaccine being effective and safe in that cohort, we can’t go out and solicit.
“So far the vaccine that has been authorised across the world - and there are other (places) where studies are ongoing - is largely the Pfizer vaccine,” Semete-Makokotlela said.
“And that's the thing with the vaccines that I'd like to stress, the thing with Emergency Use Listing and as well as Section 21 (of the Medicines Act), is if we get data that is a much higher concern in this cohort, we can as a regulator review that, and then make a different decision.
“So with all of these (factors), there is reporting that is required so that we continuously monitor these cohorts, but as we speak, we only received an application for this cohort from Pfizer.”
The Section 21 Unit (Orthodox Medicines for Human Use) of Sahpra processes and evaluates applications from applicants (treating practitioners) for access to unregistered medication within South Africa.
The South African Paediatric Association (SAPA) welcomed the approval, with the group’s Professor Mignon McCulloch saying parents have nothing to be concerned about.
No date has been announced yet for the vaccine rollout for this age cohort.
While Pfizer is the only one approved for now, recently Phase III of the Sinovac’s CoronaVac pediatric vaccine study kicked off at Sefako Makgatho Health Science University's MeCru Research Unit.
The vaccine study will see more than 2 000 children and teenagers take part in the study in South Africa, with seven clinical research sites across the country being utilised.