Current paediatric recommendations

COVID-19 vaccination is recommended for all individuals aged 12 years or older.

Comirnaty™ (Pfizer) and Spikevax (Moderna) both have provisional registration for use in individuals aged 12 years and over. Vaxzevria (AstraZeneca) has provisional registration for use in those 18 years and over but is not the preferred vaccine for those aged under 60 years.

Why have COVID-19 vaccine rollouts not prioritised children?

To date, COVID-19 infections, including the delta variant, have produced more severe disease outcomes in adults and the older population. Children have generally experienced milder symptoms and lower disease severity. For this reason, initial COVID-19 vaccine clinical trials and vaccine rollouts have focused on the adult population, especially in the context of limited vaccine supplies.

Research and modelling data shows that not only do child and adolescent groups play a lesser role in SARS-CoV-2 transmission at a population level, but that prioritising vaccination in older age groups would bring greater population-level benefit against COVID-19 disease.

Do we need to vaccinate children against COVID-19?

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 to other more vulnerable members of the community.

Thus, consideration of the benefits and risks of COVID-19 vaccination in the child and adolescent group is a delicate balance. Factors to consider include:

  • efficacy and safety profile of vaccines specifically in these age groups
  • data on complications of COVID-19 disease in the child and adolescent group, including conditions such as Paediatric Multisystem Inflammatory Syndrome Temporally associated with SARS-CoV-2 (PIMS-TS), as well as long COVID-19 symptoms. The impetus for priority vaccination for protection against disease increases as the incidence and risk profile for complications increases
  • children in specific subgroups, such as those with underlying medical conditions and Aboriginal or Torres Strait Islander Peoples may be at higher risk of severe outcomes
  • other strategies to reduce risk of transmission of paediatric COVID-19 disease, as well as to mitigate intangible impacts on children and adolescents such as mental health harms and disruptions to socialisation and education are also important.

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 in the future. This will depend on safety and efficacy data from the paediatric clinical trials.

What other strategies are there to reduce transmission of COVID-19 in the paediatric age group?

Non-vaccination strategies to reduce risk of transmission of paediatric COVID-19 disease are also important.

The “cocooning” impact of having adults (parents and teachers) in the household and classroom vaccinated is currently the best way to protect children, especially those under 12 years of age who are currently ineligible for COVID-19 vaccination.

Consideration of multi-layered mitigation strategies within a school setting comprising of a combination of standard precautions, such as hand hygiene, along with other strategies such as masking, adequate ventilation and appropriate distancing are also important.

COVID-19 clinical trials involving children

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

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

Comirnaty™ (Pfizer)

2,260 adolescents (aged 12 to 15 years) were enrolled in a phase 3 trial in the United States (US).  A strong immune response was also observed with 100% efficacy 7 days after dose 2 of the vaccine, with 18 cases of COVID-19 infection observed in the placebo group (n=1,129) versus zero cases in the vaccinated group (n=1,131).

After dose one and before dose two, there were 3 COVID-19 cases (within 11 days after dose one) among Comirnaty™ (Pfizer) recipients compared with 12 cases in the placebo group resulting in vaccine efficacy of 75%. The vaccine was well tolerated with similar side effects to those observed in adults following vaccination.

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, aiming to recruit 4,500 children. 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). Evaluation of efficacy and safety in these age groups continues, with results expected in late 2021.

Spikevax (Moderna)  

phase 3 trial in the US investigating the safety and efficacy of Spikevax (Moderna) in children aged 12-17 years has shown efficacy against confirmed symptomatic COVID-19 disease was 93.3% (commencing 14 days after dose 2 of vaccine. 1 case in vaccine group, 7 cases in placebo group). There were no cases of severe COVID-19 or deaths in the study cohort.

Canada has recently approved Spikevax (Moderna) to be administered for all 12-17 year olds.

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.

Vaxzevria (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 Vaxzevria (AstraZeneca). This trial has been paused as a precautionary measure following reports of blood clots in adults who have received Vaxzevria (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.

Are there specific vaccine safety considerations for children/adolescents?

In the Comirnaty™ (Pfizer) phase 2/3 clinical trial in adolescents, local and systemic adverse events within seven days following vaccination were frequently reported at rates similar to adults. Importantly, they were generally mild to moderate and usually resolved within 1-2 days. In the phase 2/3 Spikevax clinical trial, local injection site reactions occurred in over 90% of participants aged 12-17 years of age after both doses but were again mostly mild and resolved quickly.

There have been reports of myocarditis and pericarditis following COVID-19 mRNA vaccines in the UK, US, Canada and Israel, including in the adolescent age group. There is a greater risk in young males (<30 years) and following dose 2 of a mRNA vaccine.

Ongoing evaluation and assessment of the rate and/or severity of myocarditis or pericarditis in adolescents aged 12-15 years old compared to older age groups is ongoing. Vaccine trials in this age group have also been extended to better evaluate and assess the safety risks surrounding this adverse event of special interest.

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)

Reviewed by: Daryl Cheng (MVEC Medical Lead), Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: September 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.