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Paediatric COVID-19 vaccine receives provisional approval

16 December 2021

Medsafe has granted provisional approval for the Pfizer COVID-19 vaccine for children aged 5 to 11 years old.

Medsafe Group Manager, Chris James, says the Pfizer COVID-19 vaccine for this age group is an adapted version of the vaccine used for people aged 12 and older. The provisional approval is for two doses of the paediatric Pfizer COVID-19 vaccine, given at least 21 days apart.

“The Medsafe team has worked tirelessly this year to ensure that COVID-19 vaccine applications are prioritised and urgently reviewed, while still maintaining the same scrutiny that all medicine applications undergo before they can be approved.

“Medsafe will only approve a vaccine or medicine for use in New Zealand once it is satisfied that it has met high standards for quality, safety and efficacy,” says Mr. James.

The Ministry of Health’s National Immunisation Programme Director, Astrid Koornneef, says that work is well underway to prepare for the potential rollout of the paediatric Pfizer COVID-19 vaccine in New Zealand.

“Medsafe approval is the first step in the process, and the COVID-19 Vaccine Technical Advisory Group is now providing advice to the Ministry of Health to inform Cabinet’s decision whether to use the vaccine in New Zealand.

“If Cabinet agrees to use the vaccine in New Zealand, we want to have systems in place to roll out the vaccine safely and efficiently, at the earliest opportunity. This means completing the necessary training and working with the community to roll out the vaccine, including through whānau-based approaches,” says Ms. Koornneef.

If approved by Cabinet, the rollout of the paediatric Pfizer COVID-19 vaccine is expected to start in New Zealand no later than the end of January 2022.

ENDS

NOTES TO EDITOR:

  • Side effects of the paediatric Pfizer COVID-19 are reported to be similar to those experienced by older age groups. This includes common side effects such as headache, a sore arm and fatigue following vaccination. The FDA in the United States and the TGA in Australia have also granted provisional approval or emergency use authorisation for the Pfizer COVID-19 vaccine for 5 to 11 year olds. The vaccine is currently being rolled out in the United States to this age group.

Q&As

Will New Zealand provide paediatric vaccines to the Pacific?

New Zealand officials are in discussion with health officials from the Realm and Pacific countries to discuss the potential rollout of Pfizer paediatric vaccines, and whether the individual countries wish to do so.

How many paediatric vaccines has New Zealand ordered and when will they arrive?

Officials are currently in discussion with Pfizer to determine the earliest delivery date. This is expected as early as next month, with the rollout to start no later than the end of January.

We will have access to enough doses to vaccinate all 5-11 year old New Zealanders as well as those turning 5 in 2022.

Will children 5-11 years old be required to have a My Vaccine Pass to access non-essential services?

This has not yet been determined.

Will certain populations be prioritised for the paediatric vaccine rollout?

We are working with iwi, DHBs, local providers, communities and the Ministry of Education to roll out the Pfizer vaccine to children in a whānau-based model. Some clinics may also offer other childhood immunisations.

Will a booster vaccine be needed?

Medsafe has provisionally approved a booster dose of the Pfizer vaccine for adults aged 18 and older.

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