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Wellington: New Zealand’s medical regulator has granted provisional approval for the Pfizer/BioNTech COVID-19 vaccine to be given to 12 to 15-year-olds.
Medsafe had already approved it for use in those 16 and older, and the move follows a decision to approve the vaccine for use in 12 to 15-year-olds by other regulators in Europe, the US, Canada, and Japan.
It will allow 265,000 people in the age bracket to be vaccinated by the end of the year, if the Ardern government’s vaccine rollout goes according to plan.
New Zealand Prime Minister Jacinda Ardern receives her first Pfizer vaccination on Friday. Ardern’s first dose comes four months after the first person was vaccinated in New Zealand.Credit:Getty Images
It has 10 million doses of Pfizer on order in 2021, enough for 5 million people – meaning the new rules shouldn’t lead to anyone else missing out.
But about 1 million doses have actually arrived in New Zealand so far.
Prime Minister Jacinda Ardern said the decision was based on the most up-to-date medical knowledge.
“After careful consideration of the most up-to-date scientific and medical data available, Medsafe has announced provisional approval for our young people to be given the Pfizer vaccine,” Ardern said.
New Zealand Prime Minister Jacinda Ardern stands with students from Te Wharekura o Manurewa school as they perform ahead of receiving her first COVID-19 Pfizer dose on Friday.Credit:Getty Images
“Medsafe’s approval has been a very carefully considered and robust process, with safety the key priority.”
“There are around 265,000 children in the 12-15 age bracket and our existing Pfizer purchase order contains more than enough doses to cover two shots for this entire group.”
“We don’t need to buy any more to cover them, and no one will miss out as a result of this decision.”
She noted that children didn’t typically get very sick from COVID-19, but they could infect others.
“While COVID has not generally affected children as severely as it has adults, there have been cases internationally of children getting sick from the virus. In addition, children have been shown to transmit the virus, so being able to vaccinate them helps protect the wider community.”
“Put simply – when our children are vaccinated, their teachers, friends, siblings, parents and grandparents are more protected from the virus too. So it’s in all of our interests for this group to get the vaccine.”
Young people are not expected to start receiving the vaccine until October.
“The next step is for the government to review advice from the Ministry of Health about the ‘decision to use’, and we expect to make a decision later this month. Until that decision is made, youth aged 12-15 won’t be given the vaccine,” Ardern said.
During the wide rollout Ardern expected high schools could be used. She said the Ministry of Education had already been talking to the Ministry of Health about this.
Provisional approval means Pfizer must meet certain conditions including supplying more data to NZ from ongoing medical trials.
The Pfizer/BioNTech vaccine has the same approval for use in adults, as does the annual flu vaccine.
Medsafe is currently considering applications from two other vaccine manufacturers: AstraZeneca and Janssen, with a decision on the Johnson&Johnson/Janssen vaccine expected soon.
New Zealand purchased millions of doses of these other vaccines before deciding to buy enough Pfizer for every New Zealander. Janssen is expected to be used for those who are allergic to the Pfizer vaccine.
In Australia, the Therapeutic Goods Administration and the Australian Technical Advisory Group on Immunisation are reviewing evidence on the safety, quality and effectiveness of COVID-19 vaccines for children and teenagers before recommending they be vaccinated.
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