SINGAPORE — Singapore's Health Sciences Authority (HSA) on Friday (10 December) approved the use of the paediatric doses of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11, with vaccinations for the age group planned to begin before end-2021.
The Ministry of Health (MOH) said in a press release that it will work with the Ministry of Education (MOE) and the Early Childhood Development Agency (ECDA) to roll out vaccinations for the school-going age group.
More details will be announced by the MOE and ECDA "shortly", the ministry added.
The Pfizer vaccine will be the first COVID-19 vaccine the HSA has granted approval for use in Singapore for those aged 5 to 11, said the MOH, adding that the expert committee on COVID-19 vaccines has recommended its use for the age group.
The committee "has assessed that the benefits of the Pfizer-BioNTech/Comirnaty vaccine outweigh the risks when used in a paediatric dosage for children aged 5 to 11 years, especially given ongoing community transmission and the emergence of the Omicron variant", the ministry added.
In line with the committee's recommendations, children with moderate to severe chronic medical conditions should be prioritised for access to the vaccine.
Similar to the practice in the US, the recommended dosage of the Pfizer vaccine for the age group in Singapore is one-third of that used in those aged 12 and above.
Younger children would be given two paediatric doses, 10 micrograms each, that is spaced at least 21 days apart.
90.7% efficient based on trials; Pfizer jab registered in S'pore
The HSA in a separate release on Friday said it had reviewed the clinical data for this subgroup which showed that the paediatric dose" induced a robust immune response that was comparable" to that with 30 micrograms observed in those aged 16 to 25.
"The vaccine efficacy was estimated to be 90.7 per cent based on an ongoing Phase 2/3 study in children aged 5 to 11 years," it added. A total of 2,186 participants were randomised to receive either the vaccine or the placebo: 1,450 received the vaccine and 736 received the placebo.
The overall safety profile of the vaccine in the age group, based on safety follow-up data with a median duration of two months after vaccination, was observed to be comparable to that seen in adults and adolescents, said the HSA.
Side effects such as injection site pain, fatigue, headache, chills, and fever were generally reported less frequently and were milder in severity in the children compared to adolescents. These side effects generally resolved on their own within a few days.
While there were no reports of myocarditis, pericarditis or anaphylaxis observed in the clinical study, the HSA said it has required Pfizer-BioNTech to continue to provide information on the safety and efficacy of the vaccine in this younger age group, given the relatively small number of subjects in the clinical trial, and the potential risks of these rare adverse events.
The HSA also said that Pfizer-BioNTech had submitted an application to transition the current interim authorisation for the Comirnaty vaccines under the pandemic special access route to product registration.
The authority added that it has assessed the data accrued to-date on the manufacturing process and has concluded that the clinical studies are sufficient to register the vaccine, with effect from Friday.
Authorities had last month announced that Singapore has signed a new supply agreement with Pfizer for its COVID-19 vaccine, including doses for children.
Singapore's booster vaccination drive extended
Meanwhile, from next Tuesday, those aged 18 to 29 here can get their mRNA booster shots, provided at least five months have passed since their primary doses.
The mRNA vaccines – developed by Pfizer and Moderna – under Singapore's booster vaccination programme can be used interchangeably as boosters.
"While the primary series vaccinations provide excellent protection against severe disease, there is evidence of waning protection against infection over time, albeit at a slower pace in younger persons," said the MOH.
Eligible individuals will be invited to make an appointment for their booster dose via a short message service (SMS) with a personalised booking link that will be sent to their registered mobile number.
As of Thursday, the total number of individuals who have completed their full regimen or received two doses of COVID-19 vaccines is 96 per cent of the eligible population.
Among the total population, 87 per cent have done so, while 87 per cent has received at least one dose, and 30 per cent has received their booster shots.
While encouraging, the MOH said more people need to be vaccinated and boosted, especially given the emergence of Omicron.
"Vaccinations and boosters are the best protection against an unknown and highly transmissible COVID-19 variant," the ministry noted.
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