Australia’s Drug Regulator Grants Pfizer Vaccine Provisional Approval for 5-11 Year Olds

By AAP
AAP
AAP
Australian Associated Press is an Australian news agency.
December 4, 2021 Updated: December 4, 2021

A coronavirus vaccine for children as young as five has taken a step closer in Australia to being recommended and could be available early in the new year.

The Therapeutic Goods Administration has given its provisional approval for Pfizer’s COVID-19 vaccine for five to 11 year olds.

“In making this regulatory decision, the TGA carefully considered data from clinical trials conducted in the United States, Finland, Poland and Spain which included participants 5 to 11 years of age,” the regulatory body said in a statement. “The study demonstrated effectiveness by showing that the immune response to the vaccine in children was similar to that seen in older age groups.

“Clinical trials also showed that the safety profile in children is similar to that seen in adults with the observed side effects being mild. The most frequent adverse events seen in clinical trials in children aged 5-11 years were injection site pain, fatigue, headache, injection site redness and swelling, muscle pain and chills.”

Federal Health Minister Greg Hunt says, subject to final checks from the vaccination experts on the Australian Technical Advisory Group on Immunisation, the federal government could start rolling out the Pfizer vaccine to 5 to 11-year-olds as early as Jan. 10.

“Once the final ATAGI advice is received, further information on how to book a COVID-19 vaccination will be provided,” Hunt’s office said in a press release.

The government said that the TGA is also currently considering an application by Moderna to approve its pediatric COVID-19 vaccine.

“[T]he government already has supply deals in place to make it available should it be approved by the TGA and recommended by ATAGI,” Hunt’s office said.

TGA deputy secretary Prof. John Skerritt says the Pfizer pediatric vaccine will be one-third the dose of the adult version but have the same vaccine molecule and will come in a different colour.

“We are confident in the safety of this, Skerritt told reporters.

“We have joined a number of other countries, although we are among the first. The United States has been rolling out this vaccine for about three weeks. Canada has started its rollout, Europeans and the Israelis have also approved it.”

The decision comes against the back drop worries over the new coronavirus Omicron variant and ongoing protests against government COVID-19 response policies and vaccine mandates currently targetting essential workers.

Daniel Kim, a 28-year-old who was told he could no longer continue his physiotherapy course at university due to this decision not to take a COVID-19 vaccine, said that he finds the state government mandates “an affront” on his rights.

“If you read the Bible, you know that each of us is imbued with a spirit, and each of us has the ability to make free choices for ourselves. That’s how God made us, and so for the government to intervene and say that we are now superseding your ability to make a choice for yourself, I find that unconscionable,” he told The Epoch Times at a protest in Sydney last month.

Australia protest
Daniel Kim, 28, attended an anti-vaccine mandate protest in Sydney, Australia, on Nov. 20, 2021. (The Epoch TImes)
Australians Protest
Protesters take part in the ‘World Wide Rally For Freedom’ in Sydney, Australia, on Nov. 20, 2021. (Lisa Maree Williams/Getty Images)

“I’m not saying COVID hasn’t killed people, I’m not saying people haven’t gotten very sick, but that never ever should be an excuse for governments to say that, all of those lessons we learned decades ago are irrelevant … We have no idea what sort of ramifications this is going to have in terms of the reputation of the health industry, the medical industry, all of those institutions that we trusted.”

Christmas travel plans of thousands of Australians from the nation’s two biggest states are now in doubt, with South Australia tightening its border over concerns about the new virus strain.

Premier Steven Marshall hasn’t ruled out locking out travellers from NSW, Victoria, and the ACT only days after they were welcomed back for the first time in months.

“It may become necessary. I hope it doesn’t,” he said in a press conference on Saturday, before SA reported five new cases amid its unfolding outbreak.

“We would only do that if we wanted to make sure that we still enjoy a Christmas here in SA. This is a balancing act.”

Chief Public Health Officer Professor Nicola Spurrier on Saturday recommended to the state’s COVID-19 directions committee that borders be shut.

But instead, the committee agreed to require all arrivals from NSW, Victoria, and the ACT be tested upon arrival.

There have been 15 cases of Omicron so far detected in Australia: 13 in NSW, one in the Northern Territory, and one in the ACT.

NSW reported 286 new cases and one death on Sunday.

In Victoria, a further 980 new infections and seven more deaths were added. The state is yet to find an Omicron infection as it manages more than 14,000 cases.

There were three local cases announced in Queensland on Saturday and four in hotel quarantine, one of them a possible Omicron infection linked to a visitor from South Africa.

The ACT reported seven new local cases, one suspected to be Omicron.

The Epoch Times contributed to this report.

AAP
Australian Associated Press is an Australian news agency.