The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details.

Please note that COMIRNATY is subject to additional monitoring and therefore an inverted black triangle has been added to the SPC, PIL and PI. 

The SPCs have been updated as follows:

4.1 Therapeutic indications

Modify the therapeutic indication alongside the 3mcg to 10mcg posology change.

4.2 Posology and method of administration

Dosing regimen simplification (i.e. 2-dose 10mcg primary series) in vaccine-naive individuals) aged 6mo-4yo based on C4591048 SSA phase 2/3 Groups 1-5: 

•

o

 ≥6 months to <2 years: 2-dose 10 mcg primary series

 ≥2 to <5 years: 2-dose 10 mcg primary series

4.8 Undesirable effects

Support the approved 10mcg single dose simplified posology in vaccine-naïve children from 5 to 11 years of age based on C4591048 SSE. C4591048 SSE was supportive data.

ADR Table updated with side effects for participants 6 and 23 months of age.

5.1 Pharmacodynamic properties

Editorial changes.

Support the approved 10mcg single dose simplified posology in vaccine-naïve children from 5 to 11 years of age based on C4591048 SSE. C4591048 SSE was supportive data to the earlier Agency approved (EMEA/H/C/005735/II/0177/G, CHMP Opinion: 22 June 2023, EC decision: 08 August 2025) 10 mcg single dose simplified posology in individuals 5 years of age and above, which at the time, was based on 06th- 07th June 2023 EMA/ECDC published guidance (https://www.ema.europa.eu/en/news/ema-and-ecdc-statement-updating-covid-19-vaccines-target-new-sars-cov-2-virus-variants). 

6.3 Shelf life

 Editorial changes.

Statement updated on unopened vials storage conditions.

6.5  Nature and contents of container

Editorial changes.

6.6 Special precautions for disposal and other handling

Editorial changes.

8.  MARKETING AUTHORISATION NUMBER(S) 

Editorial changes.

SPC for Comirnaty JN.1 10 micrograms/dose concentrate for dispersion for injection

All reference to Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection have been deleted from all sections 1-8 of the annex.

The PIL has been updated to reflect the SPC changes.

See PIL tick list for sections updated.

The PI has been updated to reflect the SPC changes.

The PI has been updated as follows: Side effects section updated in line with SPC updates.

The packaging (label/carton) is not affected.

Implementation Responsibilities – Brand Marketing

SPC Ireland brand marketing 

Please implement in line with the Ireland Addendum to the Global Commercial Content Policy for the Review and Approval Procedure for Promotional Materials.

PI Ireland brand marketing

Please implement in line with the Ireland Addendum to the Global Commercial Content Policy for the Review and Approval Procedure for Promotional Materials.

The PILs have been updated with the new batch release site.

The SPCs have been updated as follows:

4.8 Undesirable effects

Section updated on data from Study C4591054 Substudy A and Substudy B (1MPD immunogenicity data from SSA and SSB and the 6MPD safety data from SSA and SSB).

5.1 Pharmacodynamic properties

Section updated on data from Study C4591054 Substudy A and Substudy B (1MPD immunogenicity data from SSA and SSB and the 6MPD safety data from SSA and SSB).

The SPC have been updated as follows:

6.5 Nature and contents of container

Introduction of new pack size – 1 pre-filled syringe

8. Marketing Authorisation Number (s)

Section updated with new MA number for 1 glass pre-filled syringe presentation.