This morning, the Therapeutic Goods Administration (TGA), Australia’s medical regulator, announced it has provisionally approved the Pfizer/BioNTech mRNA COVID-19 vaccine for children aged 12–15. Previously, there was approval for both the Pfizer and AstraZeneca vaccines only for people aged 16 and over.
The news was welcomed by Dr Philip Britton from the University of Sydney, who says the decision “reflects published evidence, and is in line with approvals and use in similar settings overseas”.
That published evidence is based on trials in the USA, says Professor Fiona Russell from the Murdoch Children’s Research Institute.
“This vaccine is now routinely being given to all teenagers over 12 years old in the US and Canada, so millions of teenagers have already received the vaccine,” she says.
Griffith University’s Professor Adam Taylor says that although the US safety and efficacy trial was small, including around 2,000 12–15-year-olds, “the efficacy of the Pfizer vaccine in this age group was 100 per cent, meaning no cases of COVID-19 were detected in those participants that received two injections of the Pfizer vaccine 21 days apart”.
“No vaccine-related serious adverse events were reported,” he adds.
Russell points out that there are, however, known rare adverse side effects of the Pfizer jab: “The close monitoring that follows the rollout of a vaccine in a population has detected a rare side effect in which the heart muscle (myocarditis) or lining (pericarditis) can become inflamed.”
She says that while these rare events are more common than the blood-clotting problems linked to the AstraZeneca vaccine, they are “far less severe – no serious ongoing problems have been detected”.
However, with the Pfizer vaccine in short supply in Australia, will younger teens even be able to get hold of it?
“Availability remains constrained,” says Britton, “and given that COVID-19 is mild in the great majority of children, it need not be prioritised in this age range at a population level at the moment.”
Other experts agreed that vaccinating adults, particularly the most vulnerable, should remain Australia’s priority.
“Adults are more likely to suffer severe complications, hospitalisations and death, so our priority here in Australia and around the world is to have high coverage in adults, especially the vulnerable age groups and those who are immunocompromised or have chronic medical conditions,” said the University of Adelaide’s Professor Helen Marshall.
It’s a view reflected by University of Sydney Associate Professor Nicholas Wood: “Vaccinating large numbers of adults will allow us to prevent deaths and serious illness, and therefore reduce the burden on health systems. That’s the primary goal.”
But Russell adds that “it is important that teens with underlying conditions that make them at higher risk of severe COVID-19 outcomes are prioritised in phase 1b immediately”.
However, not all experts believe that vaccinating teens in wealthy countries such as Australia represents the most worthwhile use of limited global vaccine supplies.
“Vaccine supply is too scarce at the moment,” says Dr Vinod Balasubramaniam from Monash University Malaysia. “In my opinion, it is not ‘morally right’ to prioritise children for the current COVID-19 vaccine when thousands are dying in many countries without even getting a single shot.”
You can read more of the Australian Science Media Centre’s Expert Reaction to the announcement here.
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