Australian drug regulator grants provisional approval for Pfizer vaccine for ages 5-11


Coronavirus vaccines for children up to the age of 5 are one step closer to being recommended in Australia and may be available at the beginning of the new year.

Therapeutic Goods Bureau Provisional approval For Pfizer’s COVID-19 vaccine for ages 5-11.

“In making this regulatory decision, TGA carefully reviewed data from clinical trials conducted in the United States, Finland, Poland and Spain, including participants aged 5 to 11 years,” the regulatory body said in a statement. I am saying. “This study demonstrated efficacy by showing that the immune response to a pediatric vaccine is similar to that seen in the elderly group.

“Clinical trials have shown that the safety profile of children is similar to that seen in adults, and the observed side effects are mild. In clinical trials in children aged 5 to 11 years. The most common adverse events were pain at the injection site, malaise, headache, redness and swelling at the injection site, muscle pain and cold. “

Federal Health Minister Greg Hunt said the federal government could begin deploying the Pfizer vaccine to ages 5-11 as early as January 10, subject to a final check by vaccination experts from the Australian Immunotechnology Advisory Group. It states.

“Once we receive ATAGI’s final advice, we’ll provide you with more information on how to book a COVID-19 vaccination,” Hunts’ office. Said In a press release.

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

“”[T]The government has already signed a supply contract to make it available when approved by TGA and recommended by ATAGI, “Hunts’ office said.

Professor John Skelrit, deputy secretary of the TGA, states that Pfizer’s pediatric vaccine is one-third the dose for adults, but the vaccine molecule is the same and the color is different.

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

“We are one of the first countries, but we are also participating in many other countries. The United States has been rolling out this vaccine for about three weeks. Canada has begun rolling it out, Europeans and Israel. People also approved it. “

This decision opposes background concerns about the new coronavirus omicron variant and continued protests against the government’s COVID-19 response policy and vaccine obligations targeting today’s essential workers.

28-year-old Daniel Kim, who was told he couldn’t continue his physiotherapy course at college because of this decision not to get the COVID-19 vaccine, has the state government mandating “insults” on his rights. He said he felt.

“Reading the Bible reveals that each of us is infused with spirit and that each of us has the ability to make free choices for ourselves. That is what God makes us. I don’t think it’s conscientious because it’s the way the government intervenes and replaces the ability to choose for yourself, “he said last month in Sydney. In a protest at the Epoch Times, he told the Epoch Times.

Australian protest
Daniel Kim, 28, participated in the anti-vaccine campaign in Sydney, Australia on November 20, 2021. (The Epoch Times)
Australian protest
Protesters will participate in the “World Wide Rally For Freedom” held in Sydney, Australia on November 20, 2021. (Lisa Maree Williams / Getty Images)

“I’m not saying that COVID isn’t killing people. I’m not saying people aren’t so sick, but all the lessons learned by the government decades ago are irrelevant. No excuses …. We don’t know how this will affect the reputation of the health industry, the medical industry, and all the institutions we trust. “

Thousands of Australians from two major Australian states are currently questioning their Christmas travel plans as South Australia tightens its borders over concerns about new virus strains.

Prime Minister Stephen Marshall does not exclude travelers from New South Wales, Victoria, and ACT from being banned just days after they were welcomed for the first time in months.

“May be necessary. He said at a press conference on Saturday before SA reported five new cases in its outbreak.

“We only do that if we want to make sure we’re still enjoying Christmas here in SA. This is a balancing act.”

On Saturday, Professor Nicola Sparia, Chief Public Health Officer, recommended to the state’s COVID-19 Directive Committee to close the border.

But instead, the Commission agreed to require that all arrivals from New South Wales, Victoria, and ACT be tested on arrival.

To date, 15 cases of mascot have been detected in Australia, 13 in New South Wales, 1 in the Northern Territory and 1 in ACT.

NSW reported 286 new cases and one death on Sunday.

In Victoria, an additional 980 new infections and 7 deaths have been added. Since the state manages more than 14,000 cases, Omicron infection has not yet been discovered.

Three local cases were announced in Queensland on Saturday, and four cases were announced in the hotel quarantine. One of them could be an Omicron infection associated with a visitor from South Africa.

ACT reported cases in seven new regions. One is suspected to be Omicron.

The Epoch Times contributed to this report.