/ 13 September 2021

Pfizer vaccine approved for children older than 12, but roll-out not yet on the way

Safrica Health Virus Vaccine
A healthcare worker administers a SINOVAC Covid-19 vaccine on a minor during the Numolux/SINOVAC Paediatric Covid-19 Vaccine Clinical Trial at the Sefako Makgatho Health Sciences University in Pretoria, on September 10, 2021. - The primary objective of the study is to evaluate the efficacy of two doses of CoronaVac against confirmed symptomatic COVID-19 cases in children and adolescents aged 6 months to 17 years. Efficacy will also be evaluated against hospitalization and severe COVID-19 cases. The study worldwide will enroll 14 000 children and adolescents in various pediatric age group cohorts across 5 countries (South Africa, Chile, Philippines, Malaysia and Kenya). (Photo by Phill Magakoe / AFP)

Children aged 12 years and older may now be given a shot of the two-dose Pfizer vaccine. This follows an announcement on Sunday by the South African Health Products Authority (Sahpra, approving the use of the Pfizer Comirnaty vaccine in terms of section 21 of the Medicines Act to include individuals aged 12 years and older.

According to the regulator, a review of updated safety and efficacy information, as conditions of section 21 initially authorised in March this year, led to the decision to allow the emergency use of the vaccine in this age group. The vaccine is also authorised for use in children 12 and older by the US Food and Drug Administration.

“The Pfizer vaccine has been approved for those aged 12 years and older on 11 August. The dosage would be the same and the number of doses are the same for both 12 years and older [and] 18 years and older,” said Silverani Padayachee, Sahpra’s pharmaceutical-evaluation senior manager.

Padayachee was speaking during an interview on Newzroom Africa, in which she was also joined by Dr Nicholas Crisp, a deputy director general in the department of health.

The Pfizer vaccine is currently being administered to children aged 12 years and older in the US and UK. EU member states, among them France, Italy, Germany, Ireland and Poland, and others are also administering this vaccine to the same age group.

Sahrpra has not yet not received any applications from other manufacturers of vaccines currently available in South Africa to authorise their use for children from the age of 12 years.

But elsewhere, clinical trials are being conducted to test the safety and efficacy of the CoronaVac vaccine on children from six months to adolescents up to the age of 17 years.

“We haven’t received any applications yet for the widening of these indications to include younger age groups, but we do know that there are trials which have been approved. Some of them are currently busy with clinical trials for safety on these groups [of children] six months and older,” she said.

Padayachee said that vaccine side effects were similar for adults and younger people. These include pain at the injection site, swelling, fatigue and headaches.

There was, however, a rare side effect that boys and men could experience, and Padayachee encouraged anyone who experienced symptoms such as pain in the chest, shortness of breath or an irregular heartbeat to report these immediately. 

“There are signals that indicate myocarditis in younger individuals, especially males. We are aware of this and regulators worldwide have agreed that this is a rare side effect, but it’s something that we look out to receiving possible reports on,” Padayachee said. “We would urge individuals who are young — and it could be people who are 18 years and older, especially males — if they could report if they do feel side effects.”

Vulnerable groups a priority 

According to Crisp, the most vulnerable groups, which are mainly those aged 60 years and older, remained a priority for the vaccination roll-out. A consultation process before a decision to vaccinate children could be taken will be starting this week.

“We still need to get to another 30% in some provinces and up to 40% in others of people over the age of 60. That’s the primary target:  to get older people, who are most vulnerable, vaccinated — there’s no question about that,” Crisp said.

With the fourth wave looming and the effect that the Delta variant during the third wave had on children, Crisp said that  there was a need to protect children, but that various factors would have to be taken into consideration. These included vaccine supply, establishing protocols, and the involvement of parents or guardians. 

“There are administrative issues about whether there is sufficient vaccine, what we have done and so forth. More importantly, there is decision-making that involves the clinical practitioners and scientists in the ministerial advisory committees and then there are presentations to the various government bodies,” Crisp said. 

The department of health was also considering booster doses for healthcare workers who had been vaccinated as early as February, people who are vulnerable, and people who are immunocompromised. 

Crisp added that achieving herd or community immunity was not a primary focus, because it was a “very elusive” goal owing to how the virus is transmitted.

“So part of the balancing act is when to boost the vaccinations of those who’ve already been vaccinated, particularly the healthcare workers, who have been vaccinated since about 17 February. Then there are other vulnerable people in the community who may well benefit from the booster doses, so [there are] a number of competing demands,” he said. 

The department was also going to consider rolling out a special programme through which children who were immunocompromised could have access to vaccines without being put at risk, with the guidance of clinicians and scientists, Crisp said.