The South African Health Products Authority (SAHPRA) has given the go-ahead for children aged 12 and older to receive the Pfizer COVID-19 vaccine.
According to SAHPRA, the approved terms is in line with Section 21 of the Medicines and Related Substance Act 101 of 1965. This is also known as the Medicine Act.
“This was as a consequence of the review of updated safety and efficacy information submitted as conditions of Section 21 initially authorised on 16 March 2021,” SAHPRA said.
According to SAHPRA, Section 21 of the Medicines Act is a mechanism that enables emergency use access. The act also allows authorisation for the use of medicine, subject to certain conditions.
“The regulatory decisions of SAHPRA do not translate into a procurement decision, as SAHPRA’s mandate is limited to safety, quality and efficacy of health products.”
Why they believe that children should get vaccinated
In March 2021, the Pfizer vaccine for adults was approved by SAHPRA. Professor Mosa Moshabela, University of KwaZulu-Natal Acting Deputy Vice-Chancellor for Research and Innovation, said that the case for vaccination children are getting stronger.
“Initially, we thought COVID-19 doesn’t affect children very much from the first wave but that has changed over time. We now know that the Delta variant, the burden on children was quite high, where they can suffer from long COVID,” he said.
Furthermore, they believe that the burden has shifted to children now that more adults are getting vaccinated.
“We’ve seen outbreaks in South Africa in schools and this has limited the possibility of children catching up in terms of learning. I think, therefore, there’s a strong case to be made for children to be vaccinated, especially because schools are daily gatherings and social gatherings, and can contribute to reinfections in the households, as well as most from schools to households through these children.”
Moshable welcomes the global vaccine trial in children and adolescents
Moshable welcomes the launch of the global Covid-19 vaccine study on children and adolescents that is led by Chinese Coronavirus-vaccine maker, Sinovac Biotech.
It is said that 14 000 children from 5 countries will participate in the trial, where 2 000 will be from South Africa.
“I think SAHPRA should engage the public on the data that they have used to make this decision because it’s not something that originated in South Africa, and there’s a lot more effort on the side of SAHRPA to actually convince the South African public why they made that decision and how safe it is for the kids.”