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TGA nod to Pfizer vaccine for children in 5-11 age group in Australia: Minister

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Melbourne, Dec 5 (MNN) The Australian government said on Sunday that the Therapeutic Goods Administration had approved access for children aged five to 11 to Pfizer vaccine.

Australia’s medical regulator made a careful and thorough assessment to determine it is safe and effective and that it is in the interests of children and Australians for children in 5-11 age group to be vaccinated, Health and Aged Care Minister Greg Hunt told the media here on Sunday.

TGA approval is the first of the four steps in the whole process and the government hopes to bring forward the start of paediatric doses or children’s doses to January 10 next year, the Minister added.

“That’s a provisional date, but the message is very clear. From January 10, Australian children will have access to Pfizer vaccines,” Hunt said.

The Health Minister said that over 39.6 million doses had been administered in Australia, including 92.8 per cent first doses and 88 per cent second doses.

He said that Moderna vaccine for children is also under consideration of the TGA and it will form a view based on data in the coming weeks.

Therapeutic Goods Administration Adjunct Professor John Skerritt said that the children’s Pfizer vaccine is one third of the normal dose and extensively tested clinically.

The trial was done on almost 2,500 children aged five to 11, of which over 1,500 received a dose. And its immune response was identical to that in young adults, he said.

Skerritt said that results published in the New England Journal of Medicine showed 91 per cent efficacy of the children’s vaccine.

He said that there were no safety problems identified in those trials. Children only complained of tiredness, sore arms, headache, and so forth, as adults complain in some cases. “But these tended to be brief and fairly shortlived. So, we’re confident in the safety of this.”

He said that 2.3 million kids come in the 5-11 age group, and a bit over fifth of all COVID cases are in under-12 category. Some of the earlier data with Omicron suggests that that may actually be higher for Omicron variant.

The TGA approval is for vaccination at least three weeks apart. The Australian Technical Advisory Group on Immunisation (ATAGI) will look at the doses’ gap amid decisions in places like Canada that suggest two-month gap for stronger immune response.

Answering a media query on relaxing some international travel restrictions from December 15, Hunt said that 15 cases of Omicron variant of novel coronavirus have so far been identified in Australia while others are under investigation.

He said that he was briefed on Sunday morning by both Australia’s Chief Medical Officer Professor Paul Kelly and his deputy Michael Kidd on Omicron.

“I believe there are 41 countries, on our latest advice, that have identified the variant. So, we continue to focus on that information. We’re reviewing, daily and weekly, the travel restrictions. There are no plans to change the current proposals, but our message is very clear: safety and medical advice first. That’s been our approach throughout the pandemic, and that will continue to be the approach.

“So if the medical advice changes, then we change the rules in accordance with that. But as of this morning there was no change in that advice and no change in that time frame.”

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