The arrival of Omicron and the possibility of other emerging variants of concern highlights the great importance to protect all age groups in the population. Soon children aged 5-11 years may have access to the Pfizer vaccine subject to ATAGI advice. So, mandates for proof of vaccination of children will likely be an entry requirement for family events and venues.

However, we should also make plans to vaccinate younger children 2+ as done overseas in Asia-Pacific and Americas. It is also vital to protect pregnant women and encourage vaccinated mothers to breastfeed to provide maternal antibodies to their babies. We need to be inclusive of all age groups to reach herd immunity to slow down the spread of highly transmissible variants and impede emergence of new variants.

The best strategy to combat disease brought on by mutant viruses is to develop and sustain immunity via virus vaccination. Living with COVID-19 is better with immunity. Any level of protection is better than none.

Omicron has made us shout out louder for a variant-proof vaccine that can induce broad neutralising antibodies with long-lasting B cell memory before we face future challenges like the next variant to come.

Since the rollout of COVID-19 vaccines for children under 12, there have been approximately 5 million doses delivered across the United States, including more than 1 million second doses. Thus far, there have been no reported cases of myocarditis, the adverse event of special interest (AESI) that has been a particular focus point in the child and adolescent age group.

These real-world safety findings, along with the emergence of Omicron and other variants that may have increased infectivity and impacts on children, contribute to the ongoing benefit-risk evaluation for COVID-19 vaccination in children. If safety risks or concerns diminish, and the clinical impacts such as infection rate, hospitalisations, long COVID and PIMS-TS [Paediatric inflammatory multisystem syndrome] on the paediatric population increase due to variants of concern, the pendulum swings toward vaccinating the paediatric population.

As the immunisation rate across the population increases, this will improve protection against infection. However, this should not be an indication for mandates to be extended to children – rather they should be potentially reconsidered for all age groups in light of greater overall population coverage. Vaccine mandates should be used as a last-resort effort for population protection, rather than a first-line measure.

VACSIG supports the decision of TGA to provisionally approve Pfizer for children 5-11 years, subject to ATAGI advice. This vaccine has been found to be well tolerated, produce good immune responses and be highly efficacious against SARS-CoV-2 infection in a clinical trial.

Millions of children have had two doses of this vaccine in the US already and safety surveillance has found the vaccine to be safe. This vaccine will help protect children from infection and rare complications of COVID-19, will help prevent school outbreaks, and more broadly contribute to a reduction in community transmission.

The provisional approval of the Pfizer vaccine for 5-11-year-olds by the TGA is not surprising. Before beginning the program, ATAGI also needs to give its go-ahead to the program. Beginning the vaccination program for this age group in early January in Australia would be reasonable.

Already, it is estimated that around 2 million children aged 5-11 in the US have been fully vaccinated with two doses of the Pfizer vaccine three weeks apart. The dose is one third of the adult vaccine dose. Other countries such as Canada and Israel are also vaccinating in this age group, so the numbers are even higher.

While there are no published data as yet about the rollout in 5-11-year-olds, there are no anecdotal reports about the children experiencing any serious side effects. This is very reassuring because myocarditis and pericarditis, which are uncommon side effects of the vaccine, usually occur 1-5 days after the second dose. Waiting until January will allow us to review published data about the rollout by which time literally millions more children in this age group would have been fully vaccinated.

It is welcome news that the Pfizer vaccine has now been provisionally approved by the TGA for use in Australian children aged 5-11 years. The data from the USA is very reassuring, suggesting that the vaccine has been safe in millions of children who have received it.

There are some initial reports from South Africa that Omicron is infecting pediatric populations at a greater rate, even if it’s mild in children, more infections in children will mean more burden on the health system, and more parents having to take time off to care for children. As we have reached very high coverage in the adult population, it’s now timely that we move to vaccinate our pediatric population and ensure high vaccine coverage across the population.

The recent announcement of approval of vaccinations in children is very positive and important. Children can also get very unwell from COVID-19 and importantly can spread the virus to more vulnerable groups. Being vaccinated significantly reduces the chances of severe disease and also transmission.

Concern is mounting worldwide as the number of children below 12 years old getting infected succumbing to COVID-19 surges, with parents especially worried because schools are due to reopen/ have opened in some parts of the world. 

What is happening? We must first understand that children below 12 years old are part of the vulnerable group who are currently not vaccinated or have lower vaccinated numbers. With the highly transmissible Delta strain becoming the predominant strain behind the recent surges of infection and mortality worldwide, we seem to see a pattern of increased hospitalisation/severe symptoms with the current Delta strain circulating comparatively with fewer cases last year when there was fewer reports of variants of concern (VoCs). 

This further strengthens the need for this age group to be vaccinated immediately. As we know, the COVID-19 pandemic is already the 'pandemic of the unvaccinated!' This virus is really tracking the unvaccinated. The growing number of children hospitalised with COVID-19 could further strain an already overburdened pediatric health care system in countries worldwide.

Data show that children and particularly adolescents can play a significant part in coronavirus transmission. And concerns about transmission by children and adolescents are growing as new coronavirus variants emerge. It’s possible that more-transmissible variants will develop a way to push through whatever it is in a young person’s immune response that makes them more resistant to infection, making it all the more important that they are vaccinated.

Research has shown that the COVID-19 vaccine is safe and 91 per cent effective at preventing symptomatic infections in 5- to 11-year-olds. In the results of the study, Pfizer says the trial was conducted among 2,268 children between the ages of 5-11 who were given two shots of a 10-microgram dose of the vaccine, a third of the dose size given to people 12 and older. Even before getting FDA emergency use authorisation, clinical trials showed COVID-19 vaccines to be remarkably safe and effective for adults and teens age 12 and up. Trials involved tens of thousands of volunteers. The vaccines continue to be monitored very closely. In fact, the Centers for Disease Control and Prevention (CDC) say that COVID-19 vaccines will have 'the most intensive safety monitoring in U.S. history.'

What is the risk of myocarditis?

Scientists at the Food and Drug Administration presented an analysis showing that the protection offered to children between the ages of 5 and 11 by the COVID-19 vaccine developed by Pfizer and BioNTech 'would clearly outweigh' the risk of myocarditis, a heart-related side effect, that the vaccine appears to cause.

There have been a small number of adolescents and young adults who experienced mild cases of heart inflammation (called myocarditis) after getting the COVID-19 vaccine. Most recovered on their own or with minimal treatment and rest. However, ongoing research shows that people who became infected with COVID-19 have a greater risk of developing this potential side effect than those who receive the vaccine.

Unvaccinated children have 37 times higher chance of developing myocarditis when infected with COVID-19 than uninfected peers. Apart from that, we are also exposing children to higher risks such as long term COVID-19 infection and the multisystem inflammatory syndrome in children (MIS-C) if they are not vaccinated. So, the benefit of vaccination clearly outweighs any other concern.

How important is vaccinating children with the emergence of Omicron?

Even with variants as concerning as Delta or Omicron -- which scientists will need to study for at least two more weeks to track how contagious or dangerous it is -- vaccination still provides a level of protection against severe disease which is vital, especially in children.

How is Pfizer's vaccine for young kids different?

Pfizer's vaccine is one-third the dose of the vaccine given to everyone age 12 and older (but it's still given in two shots, three weeks apart). The needle used to administer the vaccine will also be smaller. Additionally, the cap on the vial the vaccine comes in will be orange instead of purple and grey to avoid mix-ups. The formula of the vaccine also varies slightly from the formula for adults. Pfizer's vaccine for kids can be stored up to 10 weeks in a fridge, making it easier to administer.