Australia’s top immunisation advisers will wait on safety data from at least several hundred thousand young children in the US who will be vaccinated in coming weeks before giving the go-ahead for the jab in 5- to 11-year-olds, with experts stressing risks to unvaccinated children in schools are low.
A trial of Pfizer’s paediatric COVID-19 vaccine in 1500 children was published in the New England Journal of Medicine on Wednesday. The trial found the vaccine was safe and effective.
But with low cases and high rates of adult vaccination coverage, Australia will wait to see how the vaccine plays out in reality before approving the shot, with a larger sample size needed to determine the risk of very rare complications, such as the heart condition myocarditis.
The US Centres for Disease Control and Prevention independent panel unanimously recommended Pfizer’s vaccine for children aged between 5 and 11 last week, after it was granted emergency use authorisation by the FDA. The first children received the vaccine on November 3.
Professor Allen Cheng, who co-chairs the country’s vaccine advisory group the Australian Technical Advisory Group on Immunisation (ATAGI), said he expects paediatric data on children in the US who have been double-dosed to be available within the next four weeks.
“Children are only getting their first vaccines now. So by the beginning of December we will start to see more safety data come through,” he said.
Last week, NSW Health Minister Brad Hazzard and Victorian Premier Daniel Andrews expressed optimism about having children in that age group vaccinated this year.
“There are a number of options being looked at, but no decisions have been made,” Professor Cheng said, noting consideration is being given to if the most at-risk children will be vaccinated sooner and the recommended time between first and second doses.
“All options are on the table.”
Professor Cheng said another factor in availability of shots for younger children will be acquiring the supply of the lower-dose vaccine, with children in the US approved for a third of the 30-microgram dose given to people aged 12 and over.
“The timing isn’t clear at this stage, but it would probably be at least December and possibly January before we might start administering vaccines to younger kids,” he said.
The global approach to vaccinating teenagers against COVID-19 has not been uniform. While children aged 12-15 in Australia receive the full course of Pfizer, in Britain, for instance, they only receive one dose. The US is the first country to start administering a children’s version of the vaccine.
In a statement, the Australian and New Zealand Paediatric Infectious Diseases Group said it supported cautious consideration of whether to extend vaccination programs to children aged 5-11, noting their extremely low rates of severe illness from infection with COVID-19.
There were more than 7000 cases and 244 coronavirus hospital admissions in Australian children aged 5-11 from January to the end of October, the group said. But no child under 12 has died from the virus and only a handful have required intensive care.
The group’s co-chair, University of Western Australia Associate Professor Asha Bowen, said while she was “delighted” a vaccine had been trialled, real-world data was needed to assess if vaccinating the age group was worth it.
“The side effects we have seen in the adult population, if they are apparent, are not going to be seen in such a small study,” she said.
“Making a decision for 5- to 11-year-olds about a COVID vaccine when they have really, really low direct benefits from the vaccine really needs to be done quite cautiously,” she said.
Dr Bowen said while vaccination would provide an “indirect benefit” of giving confidence to keep schools open the argument that children needed to be vaccinated to keep primary schools safe – and open – did not necessarily stack up.
“Children have had a lot of restrictions on them to protect broader society,” she said, noting that given high adult vaccination rates, other strategies including rapid antigen testing, ventilation in classrooms and hand hygiene may be better options.
Professor Robert Booy, an infectious diseases and vaccine expert who has acted as a consultant to vaccine manufacturers including Pfizer, said he supported the decision to wait for more data, noting the US plan to vaccinate its 28 million children in the age group could mean a sample of two million could be available within weeks.
Professor Booy said it was important to note other countries had taken more conservative approaches to vaccination in younger people and the approval process was designed so that health experts could make the best call without bowing to external pressures.
“The tail shouldn’t wag the dog,” he said.
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