Medsafe approval for 5-11 years - key messages and Q&A’s from the Ministry of Health Key Messages ● ● ● ● ● ●
● ●
● ●
Medsafe has granted provisional approval of the Pfizer COVID-19 vaccine for children aged 5 to 11 years old. The paediatric version of Pfizer’s COVID-19 vaccine for 5 to 11 year age group requires two doses, at least 21 days apart. Medsafe has granted provisional approval following a robust review process of the data provided by Pfizer, which has been trialled in this age group overseas. Medsafe only grants approval for a vaccine or medicine once it is satisfied that it has met high standards for quality, safety and efficacy. Pfizer’s trial results show that the vaccine produces an immune response in 5 to 11 year olds similar to that seen in other age groups. Side effects are also 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. Medsafe’s provisional approval is the first step in the process for rolling out the vaccine in New Zealand. Cabinet will consider whether to use the Paediatric vaccine for this cohort following advice from the Ministry of Health with guidance from the COVID-19 Vaccine Science and Technical Advisory Group (CV-TAG). If Cabinet approves a decision to use, the roll out is expected to start in New Zealand at the end of January. 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 age group. The vaccine is currently being rolled out in the United States to this age group.
Q&A 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?