SINGAPORE – Registration for a trial to determine how children aged five to 11 respond to Covid-19 vaccination has now concluded, and the study will begin “as soon as everything is in place”, said the KK Women’s and Children’s Hospital (KKH) on Saturday (Nov 20).
Dr Yung Chee Fu, a senior consultant from the infectious disease service at the KKH’s Department of Paediatrics said in response to queries from The Straits Times that it is targeting 150 participants aged between five and 11 for this research study, and the children will be followed for about 15 months.
The study, which is backed by the Ministry of Health, is aimed at assessing the safety and immune responses among children who receive the Covid-19 vaccines, and to “evaluate operational logistics” from rolling out the vaccine at scale.
“The data will help inform and guide public health vaccination policy for young children in Singapore…We have seen a very encouraging response from parents and caregivers,” said Dr Yung.
He added that the study aimed to recruit children who were healthy, and did not have any previous Covid-19 infection or are considered to be “highly immunosuppressed” from cancer or chemotherapy.
Participants with certain underlying but well-controlled medical conditions such as asthma or eczema were welcome to participate, said Dr Yang.
Children who are assessed to be eligible for the trial will receive two paediatric vaccine doses of the Pfizer vaccine, three weeks apart.
The paediatric doses are about one third of the adult vaccine, though they are made of a different formulation from the regular one.
For instance, while the paediatric doses use the same mRNA ingredient as the adult vaccine, a different buffer solution is used so that it can be stored under more conventional cold chain requirements.
“The child will need to have his or her blood taken at various time-points over 15 months. This is needed to help us ascertain the antibody levels and immune responses in the participant,” he added.
Participants will also complete a seven-day vaccine diary to assess any side effects.
Side effects for children are similar to that of adults, which include injection site pain, fatigue, rash, headache, and fever, which will generally resolve on their own within a few days, said Dr Yung.
“These side effects are normal signs that your body is building protection or immunity,” he added.
In line with MOH’s guidance for adolescents and young people, children are also advised to avoid strenuous activities for two weeks post-vaccination.
The vaccinations will be administered at the vaccination centre at KKH, which is set up and equipped to manage medical emergencies, he added.