SAHPRA approves Pfizer vaccine for children aged 12 and older

The South African Health Products Authority (SAHPRA) has given the green light for children aged 12 and older to receive the Pfizer COVID-19 vaccine.

According to the local drug watchdog, the approval is in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965, 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.

In addition, the watchdog said, Section 21 of the Medicines Act is a mechanism that enables emergency use access and allows it to authorise 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.”

In March, SAHPRA has approved the Section 21 application for the Pfizer vaccine for adults.

University of KwaZulu-Natal Acting Deputy Vice-Chancellor for Research and Innovation, Professor Mosa Moshabela, told the SABC that there is now a strong case for vaccinating children.

“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.

Meanwhile, he said the burden has shifted to children now that more adults are getting vaccinated and are protected.

“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 has also welcomed the launch of the main phase of a global COVID-19 vaccine study on children and teenagers, led by Chinese Coronavirus-vaccine maker, Sinovac Biotech.

The trials will be conducted on 2 000 children aged six months to 17 years, based on international data.

According to reports, the trials will enrol 14 000 children from South Africa, Chile, the Philippines, Malaysia and Kenya.

“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.”

Moshabela believes that the country needs to show that the data is there and it is compelling.