Australia Expects Regulatory Decision on Pfizer for Children Under 12 in January

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Australia, quickly becoming one of most-vaccinated nations against COVID-19, has been told by its regulators that its independent decision on whether to approve Pfizer’s COVID-19 vaccine for children could come as early as January, officials said on Sunday.

Health Minister Greg Hunt said medical regulators are still waiting for more “real-world” health and safety data for the vaccinations after the United States went ahead with an emergency approval for the Pfizer mRNA vaccine for children above the age of five.

“The expectation that they have set is the first part of January, hopefully early January,” Hunt told the Australian Broadcast Corp’s Insiders programme. “But they’re going as quickly as possible … We’re ready to go when our regulators are convinced that it’s safe and effective for children.”

The U.S. Centers for Disease Control and Prevention this month recommended the Pfizer Inc/BioNTech SE shot for broad use in the 5-11 age group, after it was authorized by the Food and Drug Administration.

However, Hunt said that the U.S. decision was based on a “very small clinical trial by vaccine clinical trial standards, only a few thousand children,” and that Australia’s regulators had said they “do not want to cut corners on the study and data for children.”

Army Lieutenant-General John Frewen, Australia’s COVID-19 Taskforce commander told The Age newspaper that Australia has secured the necessary supplies. “We have actually purchased sufficient supply for doses and boosters down to infants,” Frewen said.

On Friday, Australia crossed the 90 percent single-dose mark for those aged 16 and over, with 83 percent having two shots. The country has also vaccinated 57.7 percent of children between the ages of 12 and 15, according to health ministry data.

The Australian government said that the nation’s high vaccination rates were key to its decision to partially reopen international borders this month for the first time since the start of the pandemic, despite ongoing Delta variant outbreaks in its most populous states, New South Wales and Victoria.

On Sunday, there were 1,100 infections reported in the two states, home to nearly 60 percent of the country’s population. Five more people died.

However, despite the Delta outbreaks that led to months of lockdown in the two largest cities, Sydney and Melbourne, the national tally of just 191,000 infections and 1,596 deaths is far lower than those of many other developed nations.

Reuters contributed to this report.

Epoch Times Australia Staff

Epoch Times Australia Staff


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