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10 Dec 2021

10th Dec 2021

        The Expert Committee on COVID-19 Vaccination (EC19V) notes HSA's approval of the Pfizer-BioNTech/Comirnaty paediatric dose vaccine for use in children aged 5-11 years. The EC19V has reviewed the clinical data submitted to HSA and studied the information available globally pertaining to COVID-19 vaccines for use in children and recommends that we proceed to vaccinate 5–11 year-old children in Singapore using the Pfizer-BioNTech/Comirnaty paediatric dose vaccine when this becomes available. The vaccine should be made available under the National Vaccination Programme. 

Vaccination Shown to Protect Children from Infection and Severe Disease

2.     It is important to reduce the risk of infection and severe disease in children through vaccination. The incidence of COVID-19 in children has been increasing in tandem with the incidence of community cases. 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 (Multisystem Inflammatory Syndrome in Children), and required treatment in the intensive care unit (ICU). Children also spend a significant amount of time in communal settings e.g. schools/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.

3.    The results of the Phase 3 clinical trial of the Pfizer-BioNTech/Comirnaty paediatric dose vaccine (at 10 micrograms, one-third the adult dosage) in children aged 5-11 years, submitted recently to US authorities and HSA, has shown around a 90% reduction in the risk of symptomatic infection. 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. 

4.     Common side effects in children who received the vaccine were generally mild to moderate, and children in this age group had fewer systemic side effects compared to persons 16-25 years of age. 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. 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 5-11 years. 

5.     The EC19V thus assesses that the benefits of the Pfizer-BioNTech/Comirnaty vaccine outweigh the risks when used in a paediatric dosage (10 micrograms) for children aged 5-11 years, especially in the current situation of ongoing community and global transmission. Vaccinating this age group of children will further reduce the risk of transmission in school settings and reduce disruptions to education as well as co-curricular activities.

Two Paediatric Doses Recommended for Children Aged 5 – 11 Years

6.     The recommended dosage for children aged 5-11 years is two paediatric doses (10 micrograms each) of the Pfizer-BioNTech/Comirnaty vaccine, timed at least 21 days apart. This dosage is one third of that used in persons aged 12 years and above.

7.     Children with moderate to severe chronic medical conditions should be prioritised for access to the vaccine, as they are at higher risk of developing severe disease. These include persons with chronic conditions described in the MOH advisory on vulnerable persons, such as, but not limited to, compromise of the immune system and chronic diseases of the heart, lung, kidney and nervous system.  

Extension of Booster Vaccination to All Persons Aged 18 Years and Older

8.     While the primary series vaccinations provide excellent protection against severe disease, we have evidence that there is waning protection against infection over time. Previously, the Committee had recommended booster vaccination for all persons aged 30 years and above, and certain higher-risk groups aged 18-29 years. Findings from local and international data show that waning protection is also observed in younger persons albeit at a slower pace.

9.     In addition, 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. Boosters will strengthen the protection against COVID-19 and is 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 concern1

10.     Hence the EC19V assesses that booster vaccination is beneficial for protection against COVID-19 even in persons aged 18-29 years. The EC19V recommends that all persons aged 18 years and above, and who are fully vaccinated with their primary series vaccination, receive a booster dose of the mRNA vaccines offered under the National Vaccination Programme (50 micrograms for the Moderna vaccine and 30 micrograms for the Pfizer-BioNTech/Comirnaty vaccine).

11.     These booster vaccination doses should be taken at about five months after the completion of their primary series. Priority should be given to individuals in this age group who are at higher risk for severe disease, such as those with medical conditions, or are pregnant, as well as those at higher risk of acquiring infection, including persons travelling to other countries. 

Conclusion

12.     Extension of vaccination to include children aged 5-11 years and more persons receiving their booster vaccination, would enable our society to attain greater protection against COVID-19 infection.  While vaccination does not completely eliminate all risks of infection, it reduces the likelihood of infection; and even if infection were still to occur, it reduces the likelihood of severe disease. We therefore recommend all children aged 5-11 years to be vaccinated when the Pfizer-BioNTech/Comirnaty vaccine is offered to them, especially children with underlying chronic medical conditions who are at greater risk of suffering from severe COVID-19. Fully vaccinated persons aged 18 years and above are also recommended to receive a dose of one of the mRNA vaccines offered under the National Vaccination Programme for their booster vaccination.


EXPERT COMMITTEE ON COVID-19 VACCINATION
10 DECEMBER 2021


1 Pfizer-BioNTech reported that based on their preliminary laboratory data, a booster dose of the vaccine provides similar levels of neutralising antibodies effectiveness against Omicron as was observed after two doses against the non-VOC SARS-CoV-2 and other earlier-prevailing variants