SINGAPORE: The Pfizer-BioNTech COVID-19 vaccine has been authorised by the Health Sciences Authority (HSA) to be used for children between 12 and 15 years old, said Health Minister Ong Ye Kung on Tuesday (May 18).
From Wednesday, those aged 40 to 44 years will also be invited to register for their vaccinations, Mr Ong added.
VACCINATION FOR THOSE AGED 12 TO 15 YEARS
The Pfizer-BioNTech COVID-19 vaccine was previously given only to those aged 16 years and above. It was granted interim authorisation by the HSA under the Pandemic Special Access Route in December last year. At that time, the data for children aged below 16 years was not yet available.
Speaking at a multi-ministry task force press conference, Mr Ong said on Tuesday that the expert committee on COVID-19 vaccination has also "weighed in with their endorsement" to use the vaccine for children aged 12 to 15 years.
"Both teams have assessed that the Pfizer-BioNTech COVID-19 vaccine demonstrated high efficacy and safety for this age group of 12 to 15 years old, which is consistent with what we have observed for the adult population," he added.
The Ministry of Health (MOH) will work with the Ministry of Education (MOE) on the vaccination programme for this school-going age group and provide further updates in due course, said the Health Ministry in a separate press release.
This is the first COVID-19 vaccine authorised for use in Singapore for this age group.
In its assessment, the expert committee on COVID-19 vaccination considered the safety, efficacy and tolerability of the vaccine, and the study design of clinical trials for this age group, MOH added.
“The data showed that the Pfizer-BioNTech COVID-19 vaccine demonstrated high efficacy consistent with that observed in the adult population,” MOH added.
“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."
This follows MOE’s announcement on Sunday that all schools will move to home-based learning from Wednesday to the end of the term on May 28, after several primary school students tested positive for COVID-19. Many of the cases are linked to tuition centres.
In a separate press release on Tuesday, HSA said that Pfizer and BioNTech submitted an application to extend the use of the vaccine to those aged 12 to 15 years old.
HSA's review of the clinical data for this "subgroup" found that the Pfizer-BioNTech vaccine “induced a robust immune response” and demonstrated "high vaccine efficacy of 100 per cent".
"This vaccine efficacy was based on the ongoing Phase 3 clinical trial, which enrolled (more than) 2,000 participants aged 12 to 15 years,” HSA said.
"Based on the safety data available from a median follow-up duration of two months after vaccination, the overall safety profile of the vaccine in adolescents was comparable to that observed in adults."
The side effects noted in the trial included pain at the injection site, fatigue, headache, chills and fever, said HSA, adding that the side effects resolved on their own within a few days.
Pfizer and BioNTech will follow up on the safety and efficacy of the vaccine in the clinical study for up to two years to determine its full safety profile for this age group, said HSA. The authority will also continue to closely monitor the safety of the vaccine.
Responding to a question about how the B1617 variant appears to affect children more, MOH’s director of medical services Kenneth Mak noted that Singapore is seeing more infections in children this year compared to last year.
“It could very well be associated with viral variants of concern being more transmissible with higher viral loads. As a result of just that physical property - of these viral variants having a higher viral load - kids are also getting more infected,” he said.
“At this point in time, it isn’t clear whether infections in children lead to a more severe cause of disease associated with these viral variants of concern,” added Associate Professor Mak.
He said the children who have been infected so far are "relatively well" and are either "mildly symptomatic or asymptomatic".
"At this time we have not made any decisions yet concerning including children within our list of prioritised groups of people for vaccinations, but we will continue to watch this space, look at the evolving evidence, look at the community situation and then make decisions later on as to whether or not we need to change our plans concerning prioritisation," said Assoc Prof Mak.
VACCINATIONS FOR THOSE AGED 40 TO 44 YEARS
From Wednesday, individuals aged 40 to 44 years will also be invited to register for their vaccinations, Mr Ong announced.
“Our supply of vaccines has been steadily coming in, but remains limited given high global demand. We will continue to roll out our vaccination programme, but now in five-year age bands, starting with those aged 40 to 44 years, and progressively moving to younger age bands,” said MOH.
Individuals can register online via vaccine.gov.sg, and they will receive an acknowledgement message via SMS after registration.
A separate SMS with a personalised booking link to book a vaccination appointment will then be progressively sent to invite eligible individuals on a first-come-first-served basis, depending on when they registered.
They can expect to receive this booking message within one to two weeks from registration, with slots available until mid-June, the Health Ministry said.
Those who have previously registered their interest will not need to register again, and more vaccination slots will be made available as more supplies arrive, said MOH.
“We remain on track with our COVID-19 vaccination programme. If our supplies arrive as scheduled, we expect to be able to complete the vaccination programme by the end of the year," added the ministry.
"We strongly encourage everyone who is medically eligible to register their interest and get vaccinated when they are offered."
Watch the full news conference and subsequent Q&A session with journalists: