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Singapore approves Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11; first shots by end-2021

The Health Ministry also announced the extension of booster shots to people aged between 18 and 29.

Singapore approves Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11; first shots by end-2021

Empty vials of the COVID-19 vaccine of Pfizer-BioNTech. (File photo: AFP/Christof Stache)

SINGAPORE: The Health Sciences Authority (HSA) has extended the authorisation of the Pfizer-BioNTech/Comirnaty COVID-19 vaccine for use in children aged between five and 11, with inoculations set to begin before the end of the year.

“The vaccination regimen is to be administered as a two-dose primary series, 21 days apart, but given at a lower dose (10 microgrammes) than that used for individuals aged 12 years and above (30 microgrammes),” HSA said in a news release late on Friday (Dec 10).

This is the first time that a COVID-19 vaccine has been authorised in Singapore for use in the five to 11 age group.

“HSA has conducted a thorough evaluation of the data in consultation with two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts,” the agency said.

“Based on the current available data, the benefits outweighed the risks for use in the young population, and the vaccine met the quality, safety and efficacy standards.”

The Ministry of Health (MOH) said that the multi-ministry task force had accepted the recommendation by the Expert Committee on COVID-19 Vaccination to use the paediatric doses of the Pfizer-BioNTech/Comirnaty COVID-19 vaccine for children aged between five and 11.

The committee also assessed that the benefits of the jab outweigh the risks when used in a paediatric dosage for children aged five to 11, "especially given ongoing community transmission and the emergence of the Omicron variant", MOH said.

“Vaccination for this group will commence before the end of this year, and once we receive deliveries of the vaccine doses,” the ministry added.

MOH said that a new supply agreement with Pfizer-BioNTech for the vaccine had been signed, and the ministry expects the shipment to arrive before the end of December.

"MOH will work with the Ministry of Education (MOE) and the Early Childhood Development Agency (ECDA) to roll out vaccinations for this school-going age group," it said, adding that more details would be announced by MOE and ECDA shortly.

INCIDENCE OF COVID-19 IN CHILDREN INCREASING

Separately, the Expert Committee said that it is important to vaccinate children to reduce their risk of infection and prevent them from getting severe bouts of the disease. 

"The incidence of COVID-19 in children has been increasing in tandem with the incidence of community cases," the committee said in a statement, also released late on Friday.

"Although children have a low risk of severe disease, some of those infected with COVID-19 have developed life-threatening disease and severe late complications, such as MIS-C (multi-system inflammatory syndrome in children), and required treatment in the intensive care unit (ICU).

"Children also spend a significant amount of time in communal settings (such as schools and preschools), where despite our best efforts, transmission can spread quickly among children as they interact. This in turn also puts family members at risk, especially elderly household members."

The committee said that Phase 3 clinical trial results for paediatric doses of the Pfizer-BioNTech/Comirnaty vaccine in children between five and 11 showed about a 90 per cent reduction in the risk of symptomatic infection. The data was submitted to United States authorities and HSA.

"As cases of COVID-19 infection in the clinical trial occurred from July to August 2021, when the Delta variant was already predominant in the US, these results reflect the vaccine’s efficacy against the Delta variant," the committee added.

SIDE EFFECTS

Common side effects in children who received the vaccine were generally mild to moderate, the Expert Committee said. Children in this age group also had fewer systemic side effects compared to people aged between 16 and 25.

"While there were no cases of anaphylaxis seen in the study, the risk of anaphylaxis or allergy can be expected to be comparable to that observed in adolescents and young adults," the committee said.

"While we cannot dismiss the rare risk of myocarditis and/or pericarditis, similar to what has been reported in adolescents and young adults, no cases of myocarditis/pericarditis were observed in the trial among the children aged five to 11 years."

HSA said that Pfizer-BioNTech must continue to provide information on the safety and efficacy of the vaccine among these younger children.

"While there were no reports of myocarditis/pericarditis or anaphylaxis observed in the clinical study, given the relatively small number of subjects in the clinical trial, and the potential risks of these rare adverse events, HSA has required Pfizer-BioNTech to continue to provide information on the safety and efficacy of the vaccine in this younger age group," the agency said in a press release, issued at the same time as the ones by MOH and the Expert Committee.

"HSA will review emerging data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential safety signals."

Associate Professor Chan Cheng Leng, group director of the Health Products Regulation Group at HSA said: “HSA has carefully evaluated the scientific data on the use of Comirnaty vaccine in children and assessed that vaccination remains a critical tool during the pandemic.

"To safeguard our young children, HSA will continue to actively monitor the safety profile of the Comirnaty vaccine and will take swift regulatory actions should any safety concern emerge.”

FULL REGISTRATION

On Friday, HSA also announced that the Pfizer-BioNTech/Comnirnaty vaccine had transitioned from interim authorisation to full registration.

"Pfizer-BioNTech had submitted an application to transition the current interim authorisation for the Comirnaty vaccines under the Pandemic Special Access Route (PSAR) to product registration," the agency said.

"HSA has assessed that the data accrued to-date on the manufacturing process and the clinical studies is sufficient to register the vaccine, with effect from Dec 10, 2021."

EXTENSION OF BOOSTER SHOTS TO PEOPLE AGED 18 to 29

MOH also announced on Friday that it would extend the COVID-19 vaccination booster programme to people aged 18 to 29 with effect from Dec 14. All eligible people will be able to receive their booster doses of the mRNA vaccine five months after completing their primary vaccination series.

"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 MOH.

The Expert Committee said that booster doses should provide protection from the Omicron variant.

"Based on emerging international data regarding the Omicron variant, existing vaccines will still confer protection against the Omicron variant, even though effectiveness will be reduced compared to that against the wildtype SARS-CoV-2," it said.

"Boosters will strengthen the protection against COVID-19 and (are) expected to reduce the risk of infection and severe illnesses caused by the Omicron variant.

"Indeed, preliminary results from studies show that a booster vaccination improves the efficacy of neutralising antibodies against the Omicron variant of concern."

Those eligible for the booster shot will be invited to make an appointment. An SMS with a personalised booking link will be sent to their registered mobile number to book an appointment on www.vaccine.gov.sg.

As of Thursday, 96 per cent of Singapore's eligible population - those aged 12 and above - have completed their full vaccination regimen. About 30 per cent of the total population have received their booster shots.

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Source: CNA/kg(ac)

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