Medsafe announcement of provisional approval for two Pfizer COVID-19 paediatric vaccines

Kia ora koutou Practice Managers,  

Medsafe will be announcing at 12pm via a Gazette notice that they have granted provisional approval for two Pfizer COVID-19 paediatric vaccines:

• a booster dose of the paediatric Pfizer COVID-19 vaccine for children aged five to 11 years old; and
• the paediatric Pfizer COVID-19 vaccine for children aged six months to four years who are severely immunocompromised.

It is important to understand that Medsafe’s provisional approval does not mean that a decision has been made to use either vaccine as part of our COVID-19 vaccination programme. Instead, the Medsafe approval is only one step in the process. The COVID-19 Vaccine Technical Advisory Group (CV-TAG) is now providing advice to the Ministry of Health to inform a final decision by vaccine ministers on whether to use the vaccines in New Zealand.

If approval is indeed granted, both vaccines are expected to be available in the first half of 2023.

We will keep you updated with any decisions, and should one or both vaccines be approved, details of the operational rollout will be shared with you.

Action:  Please share the following key messages with your networks.

Key messages

• Medsafe has granted provisional approval for a booster dose of the paediatric Pfizer COVID-19 vaccine for children aged five to 11 years old.
  • The provisional approval is for a booster dose of the vaccine, given at least six months after completing the primary course (this is usually two doses).
  • Provisional approval does not mean that a decision has been made to use this as part of the COVID-19 vaccination programme.
  • Instead, this is an important step in the process and advice on whether the vaccine should be used will now be prepared by the COVID-19 Vaccine Technical Advisory Group (CV-TAG) to inform a final decision by vaccine ministers.
  • The Pfizer COVID-19 vaccine for this age group is an adapted version of the vaccine used for people aged 12 and older.
• Medsafe has also granted provisional approval for the use of the paediatric Pfizer COVID-19 vaccine in children aged six months to four years who are at higher risk of severe disease if they were to catch COVID-19.
  • The vaccine for this age group is an adapted version of the vaccine used for five to 11 olds.
  • The provisional approval is for three doses of the adapted paediatric Pfizer COVID-19 vaccine, with the second dose given three weeks after the first dose, followed by a third dose given at least 8 weeks after the second dose.
  • Advice from CV-TAG to the Director-General of Health has recommended that the eligibility is limited to children who are severely immunocompromised, or who have complex and/or multiple health conditions which increase the risk of severe disease from COVID-19 (following the Starship Child Health table of underlying comorbidities).
• Medsafe approval is only one step in the process. The COVID-19 Vaccine Technical Advisory Group (CV-TAG) is now providing advice to the Ministry of Health to inform Cabinet’s decision whether to use the vaccines in New Zealand.
• CV-TAG's recommendations will then be considered by the Director-General of Health before to a final decision to use is made by vaccine ministers.
• If approval is granted, both vaccines are expected to be available in the first half of 2023.
• Medsafe provides independent advice to the Ministry of Health. They follow a robust approval process to ensure vaccines meet acceptable standards for quality and that the benefits outweigh any risks. Medsafe only approves a vaccine or medicine for use in New Zealand once it is satisfied that it is of acceptable quality, efficacy and safety.

Ngā mihi nui,

Sandy 

Sandy Thambiah

Senior Adviser, Engagement

National Immunisation Programme

waea pūkoro: +64 21 248 1288| īmēra: sandy.thambiah@health.govt.nz

133 Molesworth Street, Te Whanganui-a-Tara

Follow us on LinkedIn | Facebook | Instagram