• The Pfizer-BioNTech vaccine against Covid-19 will be the first one authorised for children age 12 to 15
• The authorities considered the safety and efficacy of the vaccine in making its assessment
• New data shows that the vaccine is safe and effective for those in the age group
• The side effects experienced were similar to those experienced by adults so far

SINGAPORE — The Health Sciences Authority (HSA) has approved the Pfizer-BioNTech Covid-19 vaccine to be administered to children between the ages of 12 and 15.

The Pfizer-BioNTech vaccine is one of two Covid-19 vaccines that have been approved for use in Singapore, along with Moderna. This will be the first Covid-19 vaccine authorised for use among this age group in Singapore.

The expert committee on Covid-19 vaccination, which was convened to recommend a vaccination strategy for Singapore, has also endorsed the recommendation made to the Ministry of Health (MOH), Health Minister Ong Ye Kung said on Tuesday (May 18) during a briefing convened by the Government’s Covid-19 task force.

MOH and the Ministry of Education will work out the details for the vaccination programme for this group, which will be announced at a later date.

Previously, the committee had said that anyone under the age of 16 should not take the Pfizer-BioNTech vaccine. At the time, it said that there was insufficient data on the safety and efficacy of the vaccine for this group. 

But MOH said in a statement on Tuesday that new data from clinical trials for those in this age group has shown that the Pfizer-BioNTech vaccine “demonstrated high efficacy consistent with that observed in the adult population”.

It added that the expert committee considered the safety, efficacy and tolerability of the vaccine, and the study design of the clinical trials for this younger cohort during its assessment.

“Its safety profile is also consistent with the known safety profile in the adult population and the standards set for other registered vaccines used in the immunisation against other diseases.”

In one study of the Pfizer-BioNTech vaccine, which involved 2,260 children with a median age of 14 years, no severe coronavirus cases were reported during the course of the study, and no adverse events were reported after the participants received the jab.

The side effects experienced by the participants were those common among adults who have received the jab — fatigue, fever and pain at the injection spot.

The study also found that the vaccine produced a very strong antibody response particularly among 15-year-olds, even higher than for those aged 16 to 25.

While the Government has approved the use of the vaccine for those aged between 12 and 15, they are not currently on the priority list to receive the vaccination.

For now, the vaccination programme has been extended only to those between the ages of 40 and 45.

During the briefing, the task force was asked whether the Government would consider moving children in this age group to the front of the vaccination queue given that Mr Ong had earlier said the B1617 Covid-19 variant affected children more.

Associate Professor Kenneth Mak, MOH’s director of medical services, said that the authorities have observed more infections reported in children compared to last year, and that “it could very well be associated with viral variants of concern being more transmissible with higher viral loads”.

He added that worldwide, there have been reports of more children getting infected with the disease as of late as well.

That being said, Assoc Prof Mak noted that the children who have been infected here are still relatively well and they experience either mild or no symptoms.

He added that the authorities will continue to look at the data to decide whether it would be useful to give children early access to the vaccine to reduce their risk of being infected.

“We continue to keep a close watch on them to monitor them and hope they will continue to do well as they recover from these infections.”

Assoc Prof Mak said that in the meantime, the authorities will continue to teach children — who tend to mingle frequently with their friends and are less vigilant about safety precautions — and encourage them to be more disciplined when adhering to safety precautions.

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EVALUATION OF SINOVAC

The task force also had to explain why China’s Sinovac vaccine has not been approved for use in Singapore yet, and what the shelf life of the vaccine is, given that Singapore received the first shipment of the vaccines in February.

Assoc Prof Mak said that the vaccine manufacturer has given Sinovac a shelf life of up to two years, and the authorities are evaluating whether the vials can be used “as early as possible”, if the vaccine is approved for use here.

HSA is still evaluating the vaccine and waiting for more information from the manufacturer to complete its assessment.

In making their evaluation, the authorities are also considering using information gleaned from other countries who have rolled out Sinovac to its population. 

“HSA remains committed to making sure that if it approves the vaccine, it will be on the basis of assuring Singaporeans that the vaccine is both safe and effective for us,” he said.