Currently, COVID-19 vaccines are not registered for use in Australia in children aged less than 16 years. For children aged 16 years or older with an underlying medical condition, information regarding vaccination is available here. Carers of children or young adults with a underlying medical condition are also eligible for a vaccination in Phase 1b. 

The Australian Government has planned to include children aged less than 16 years in phase 3 of the COVID-19 vaccination rollout in Australia (if vaccines are proven to be safe and effective in this age group). 

Why has the COVID-19 vaccine rollout not prioritised children?

To date, COVID-19 infections have produced more severe disease outcomes in adults and the older population. Children have generally experienced milder symptoms. For this reason, initial COVID-19 vaccine clinical trials and vaccine rollouts have focused on the adult population.  

Children’s immune systems respond differently to vaccines when administered at different ages. As a result, the COVID-19 vaccine formulations, doses and schedules used for adults may not be the most appropriate for children. Children may also experience different side effects following vaccination compared with those experienced by adults. For these reasons it is important to conduct clinical trials that are specific for children.  

Do we need to vaccinate children against COVID-19?

It is important that as many people in the community, including both adults and children, are vaccinated in order to protect the whole community from COVID-19 (achieving herd immunity).  Although children seem to develop less severe disease in response to COVID-19 infection, it has been shown that healthy children can still be infected with the virus and play a role in its transmission. On rare occasions children who have experienced even mild infections can later develop the sometimes fatal condition multi-system inflammatory syndrome in children (MIS-C). Children with underlying medical conditions are at higher risk of severe outcomes, highlighting the importance of COVID-19 vaccination in this priority group. 

Will infants be vaccinated against COVID-19?

It has not yet been determined the youngest age that children in Australia will be eligible to receive COVID-19 vaccines. This will depend on safety and efficacy data from the paediatric clinical trials and if vaccines will be registered for use in these age groups.  

Are COVID-19 vaccines safe to administer in children?

Clinical trials are currently underway to determine the safety and efficacy of various COVID-19 vaccines in children. Trials will begin with teenage particpants before younger children will be included in a phased approach. No clinical trials have been completed in children below 12 years of age.

On May 10th 2021, the Food and Drug Administration (FDA) in the United States expanded their emergency use authorisation for Comirnaty™ to allow the vaccination of adolescents as young as 12 years old.  

Summaries of the most recent updates on COVID-19 vaccine trials in children (Pfizer, AstraZeneca, Novavax and Moderna) can be found below.  

Comirnaty™

Comirnaty™ currently has provisional registration in Australia for use in children aged > 16 years old.  

2,260 adolescents (aged 12 to 15 years) have been enrolled in a phase 3 trial in the United States (US). Initial data revealed 18 cases of COVID-19 infection observed in the placebo group (n=1,129) versus zero cases in the vaccinated group (n=1,131). A strong immune response was observed with 100% efficacy. The vaccine was well tolerated with similar side effects to those observed in adults following vaccination. The data is undergoing peer review.  

In March 2021 Pfizer began a global phase 1/2/3 seamless study delivering the vaccine to healthy children aged 6 months to 11 years. In the first phase, three different dosages of the vaccine – 10mcg, 20mcg and 30mcg will be tested in each age group: 6 months to 2 years; 2 years to 5 years; and 5 years to 11 years (the usual adult dose is 30mcg). This trial is currently in phase 1 as of April 2021.  

COVID-19 AstraZeneca

Recruitment of 300 children (ages 6-17 years) commenced in March 2021 for a phase 3 trial in the UK evaluating the safety and efficacy of COVID-19 AstraZeneca. This trial has been paused as a precautionary measure following reports of blood clots in adults who have received COVID-19 AstraZeneca. Children already enrolled in this study continue to be followed up, however the trial has stopped recruiting new participants.

Novavax COVID-19 vaccine candidate

There are plans for a phased paediatric Novavax COVID-19 vaccine candidate trial in the US to include children from birth to 18 years of age. Recruitment of 3000 adolescents aged 12-17 years old commenced in May 2021. 

Moderna COVID-19 vaccine  

phase 3 trial in the US is investigating the safety and efficacy of the Moderna COVID-19 vaccine in children aged 12-17 years. Initial data released in May 2021 showed an acceptable safety profile and a vaccine efficacy of 96%. 

A phase 2/3 trial in the US investigating vaccine dosing, efficacy and safety in children ages 6 months to 12 years commenced in March 2021 and plans to enrol 6,750 participants. 

Resources 

Authors: Davina Buntsma (MVEC Immunisation Fellow), Daryl Cheng (MVEC Medical Lead), Francesca Machingaifa (MVEC Education Nurse Coordinator) and Rachael McGuire (MVEC Education Nurse Coordinator)

Date: May 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.