The Health Sciences Authority (HSA), a statutory board under the Ministry of Health, and the Expert Committee on COVID-19 Vaccination (EC19V) have reviewed the safety and efficacy of the Pfizer-BioNTech/Comirnaty COVID-19 vaccine based on the clinical trials for children aged 5 to 11.
On 10 December 2021, both the HSA and the EC19V authorised the vaccine for children in this age group, as the vaccine is safe and effective for children and that benefits of the Pfizer-BioNTech/Comirnaty vaccine outweigh the risks. This was further supported by the Ministry of Health at the Multi-Ministry Taskforce Press Conference on the same day.
The safety profile of the Pfizer vaccine in the younger population is consistent with the known safety profile in the population aged 12 and above. Common side effects in children who received the vaccine were generally mild to moderate. These resolve on their own within a few days, and include injection site pain, fatigue, headache, injection site redness and swelling, muscle aches and chills. 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 of the vaccine, the risk of anaphylaxis or allergy can be expected to be comparable to that observed in adolescents and young adults. While the rare risk of myocarditis and/or pericarditis cannot be dismissed, similar to what has been reported in adolescents and young adults, no cases of myocarditis/pericarditis were observed in the vaccine trial among the children aged 5 to 11 years.
You can find out more from the HSA Website: https://www.hsa.gov.sg/announcements/press-release/pfizercomirnaty_children