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Young children could be eligible for a coronavirus vaccine as soon as the end of November after Australia’s medical regulator received preliminary data from the pharmaceutical company this week.
The Therapeutic Goods Administration boss Professor John Skerritt said once all the data is received from Pfizer the approval process will take a matter of weeks – but that work won’t be rushed.
Professor John Skerritt said the medical regulator will “dig even deeper” on the data before approving the vaccine for young kids.Credit:Alex Ellinghausen
“As soon as any medicine or vaccine is proposed for use or applied for use in children, you need to dig even deeper,” Professor Skerrit said.
“We look at safety very thoroughly for every age group but we did get even deeper for children. The trial data for children will be on more kids [than there was for] the booster, safety monitoring will be for a longer period.”
The TGA received a partial application from Pfizer on the use of its vaccine for five to 11-year-olds on Tuesday, and Professor Skerritt said the regulator expects to receive the rest of the data within the next fortnight.
“We still have more to get from the Pfizer application for five to 11-year-olds,” he said on Wednesday morning.
“I would hope that we would get there by the end of November, but it really does depend on when we get the full application from Pfizer, the complete version, and if there’s any issues,” he said.
The US has also moved a step closer to approving the vaccine for young children after a Food and Drug Administration advisory panel agreed that the vaccine’s benefits outweighed any potential risks.
The FDA has not yet approved the vaccine for young children, and if it passes that step the Centres for Disease Control and Prevention has to decide whether to recommend its use in that young cohort.
Pfizer has completed trials of its vaccine in younger children, and says a dose a third of the size of the adult dose is safe and effective in five to 11-year-olds.
The Pfizer and Moderna vaccines are approved for everyone aged 12 and over.
Health Minister Greg Hunt said across the country, 74.8 per cent of everyone aged 16 and up are now fully vaccinated.
Mr Hunt said should the vaccine be approved for younger children, there were no plans or expectations at this point for a “no jab, no play” policy.
“I think that’s likely to remain the case,” he said.
Professor Skerritt said Moderna has also indicated it is gathering data on the use of its vaccine in younger children.
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