Pfizer and BioNTech’s JN.1-adapted COVID-19 vaccine granted consent by Medsafe

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Pfizer and BioNTech’s JN.1-adapted COVID-19 vaccine granted consent by Medsafe

Media release from Pfizer and BioNTech
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Pfizer New Zealand and BioNTech announce Medsafe’s consent for JN.1-adapted COVID-19 vaccine and its availability from January 2025. The updated COVID-19 vaccine can be given to adults and children 6 months and older.

The JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY JN.1) is one of their variant-adapted COVID-19 vaccines for active immunisation to help prevent COVID-19 caused by SARS-CoV-2.1,2

The World Health Organization identified JN.1 as a variant of interest (VOI) due to its rapid spread.3,4

“We welcome this consent in New Zealand and thank Medsafe for their careful assessment of the variant-adapted COVID-19 vaccine for the 2024/2025 season. This consent reaffirms our ongoing commitment to bring a vaccine to help prevent COVID-19 to New Zealanders,” said Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director.

“With this latest registration, an updated vaccine is now available to address JN.1-related sublineages which currently account for the vast majority of COVID-19 cases globally3,4,” Dr Thiru said.

Registration of the JN.1-adapted monovalent COVID-19 vaccine is based on the full body of available non-clinical and real-world evidence supporting the efficacy and tolerability of Pfizer and BioNTech’s COVID-19 vaccines. The use of the JN.1-adapted monovalent COVID-19 vaccine should be in accordance with official recommendations.

References

1. COMIRNATY® JN.1 New Zealand Data Sheets.
2. Te Whatu Ora, Health NZ. COVID-19 vaccines additional doses. Available at: https://info.health.nz/immunisations/vaccines-aotearoa/covid-19-vaccines/covid-19-vaccine-boosters . Accessed 20th Jan 2025
3. World Health Organization. Initial risk evaluation of JN.1. 19 December 2023. Available at: https://www.who.int/docs/default-source/coronaviruse/18122023_jn.1_ire_clean.pdf . Accessed 14th January 2025.
4. World Health Organization. COVID-19 epidemiological update – 17 September 2024. Available at: https://www.who.int/publications/m/item/covid-19-epidemiological-update-edition-171 . Accessed 14th January 2025.