1 September 2023
Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) updated to reflect:
1. A variation to update the SmPC and PIL to reflect new posology for primary immunisation. The updates affect all the Comirnaty Original Products and Comirnaty Original/Omicron BA.4-5 products i.e., 5 products in total.
2. A variation to update the SmPC and PIL to extend the shelf-life. The updates affect the Comirnaty Original 10 microgram/dose and 3 microgram/dose products and both Original/Omicron BA.4-5 products i.e., 4 products in total.
Updates applicable from 24 August 2023
5 June 2023
Safety and immunogenicity information in the SmPC has been updated, based on six months post-booster dose follow-up data in recipients aged 16 year and older from studies C4591001 and C4591031.
25 May 2023
Updated Links and hyperlinks in ARCHIVE: Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (Regulation 174) attachment
17 March 2023
Updated SPCs and PILs for all Comirnaty products, to include: the uncommon side effect ‘dizziness’
& longer-term clinical trial follow-up data in 5-11 year olds.
6 January 2023
Updated the purple cap SmPC
9 December 2022
Updated the Comirnaty purple, orange and maroon cap SmPCs and PILs.
6 December 2022
Product information has been added for a new presentation of the vaccine for use in those aged 6 months to 4 years.
9 November 2022
Comirnaty 10 micrograms concentrate for dispersion for injection (one of the licensed Comirnaty vaccines produced by Pfizer/BioNTech) has been approved for use as a booster for 5- to 11-year-olds. There has also been an update to the product information for the Comirnaty vaccines on myocarditis and pericarditis after a third dose and in the age group 5-11 years. This update reflects the most up to date information about these known side effects. The GB Conditional Marketing Authorisation has been converted to a full Marketing Authorisation.
16 August 2022
Updates to the SmPC and PIL to include information about receiving a heterologous booster dose in individuals aged 18 years and over.
Updated SmPC and PIL for the purple cap product (Comirnaty 30 micrograms/dose concentrate for dispersion for injection) – shelf life and transportation storage time information updated
7 July 2022
Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech (Comirnaty) updated. 2 quality specific obligations have now been fulfilled.
24 May 2022
Updated SpC and PIL for orange cap product (Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection - Shelf-life information updated.
5 May 2022
The website decision page for the mRNA COVID-19 vaccines has been updated to reflect the fact that the 15-minute observation period following vaccination has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction.
27 April 2022
Updated information to Summary of Product Characteristics and Patient Information Leaflets (Purple Cap and Orange Cap)
13 April 2022
Updated shelf life from 9-months to 12-months for Comirnaty 30 microgram COVID-19 mRNA Vaccine (purple cap).
Updated SmPC and PIL.
25 March 2022
Updated 30 micrograms and 10 micrograms PIL and SMPC to include updated information on pregnancy and breastfeeding.
14 March 2022
PIL and SMPC Comirnaty 10 micrograms/dose concentrate: updated title to include reference to orange cap. Updated the shelf life life from 6 months to 9 months.
SMPC and PIL Comirnaty 30 micrograms/dose concentrate: Updated title to include reference to purple cap. Includes new reference to the fact there is now paediatric formulation available for children 5 to 11 years of age. Myo/pericarditis changed from a potential side effect of unknown frequency to "very rare". Erythema multiforme added as a potential side effect with unknown frequency. Wording around shelf life updated.
24 December 2021
Information for Healthcare Professionals and UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) was updated
22 December 2021
Added HTML document for Summary of product characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection
22 December 2021
Added Patient Information Leaflet and Summary of Product Characteristics for COVID-19 Vaccine Pfizer/BioNTech 10 micrograms
14 December 2021
Banner added to main page: The 15 minute observation period following a vaccination with Pfizer/BioNTech or Moderna will be temporarily suspended as part of measures to increase the booster rollout. Regulatory documents remain unchanged.
3 December 2021
The Pfizer/BioNTech vaccine (Comirnaty) Conditional Marketing Authorisation has been renewed: changes to the SmPC – section 9 and section 10.
15 November 2021
Updated sections of the Summary of Product Characteristics and Patient Information Leaflet for COVID-19 Vaccine Pfizer/BioNTech (Conditional Marketing Authorisation documents) to include information about receiving a 3rd/booster dose. Also to include two new reagents, Sodium Hydroxide and Hydrochloric Acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process. The official International non-proprietary name ‘tozinameran’ has also been added.
28 October 2021
Updated figures in HCP information Table 5: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2 – participants without evidence of infection and with or without evidence of infection prior to 7 days after Dose 2 – adolescents 12 to 15 years of age evaluable efficacy (7 days) population
27 October 2021
Update to the summary of product characteristics and patient information leaflet for the Pfizer/BioNTech vaccine condition marketing authorisation documents
27 October 2021
Updated for both HCPs and public
27 September 2021
Extended vaccine shelf life from 6 months to now 9 months.
9 September 2021
Updated sections of Information for Healthcare Professionals on COVID-19 Pfizer/BioNTech (Regulation 174) and Information for UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) to include information about receiving a third dose. Also updated the Regulation 174 Conditions document with an additional pharmacovigilance condition.
11 August 2021
Updates to the Conditional Marketing Authorisation SmPC and PIL and updates to the Regulation 174 Information for Healthcare Professionals and Information for recipients
2 August 2021
Updated conditions of authorisation for Pfizer BioNTech vaccine
9 July 2021
We have published the Summary of Product Information, Patient Information Leaflet and Conditions document for the GB Conditional Marketing Authorisation of the Pfizer/BioNTech vaccine.
28 June 2021
Updated the Public Assessment report, to reflect the extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds, as announced on 4 June 2021.
25 June 2021
Added a warning on myocarditis to the Information for UK recipients and the Information for Healthcare Professionals
4 June 2021
Updated Conditions of Authorisation, Information for Healthcare Professionals and Information for UK Recipients documents in line with an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds.
20 May 2021
Updated the Information for Healthcare Professionals, Information for UK recipients and Conditions of Authorisation documents. This is to reflect a change that once removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 1 month (31 days). This was previously 5 days.
31 March 2021
Published new versions of the Conditions of Authorisation documents, with an additional clause in the Deployment section relating to transfers of frozen vials stored at ultra-low temperature and handling of temperature excursions
9 March 2021
Added information on fevers to Section 4 of Information for UK Recipients and section 4.8 of Information for Healthcare Professionals.
28 January 2021
Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing
26 January 2021
We have updated the Product Information to state that the vaccine is manufactured with enough volume for six doses, if our latest guidance for Healthcare Professionals is followed.
31 December 2020
Updated HTML and PDF attachments for 'Conditions of authorisation for Pfizer BioNTech'
30 December 2020
Updated the Information for UK recipients and the Information for healthcare professionals documents, to reflect changes to the dosage interval, advice for women who are pregnant or breastfeeding and to those with allergies.
24 December 2020
Updated guidance for Healthcare Professionals on obtaining a sixth dose from a vial.
16 December 2020
Added an accessible HTML document: Summary of the Public Assessment Report
15 December 2020
Added the Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine
10 December 2020
Changes to section 4.2 and 6 of the Information for UK Healthcare Professionals to provide clarification following further feedback and update to section 4.4 to strengthen information on special warnings and precautions for use.
Changes to warnings and precautions and clarification in section 6 of the Information for UK Recipients.
8 December 2020
Accessible HTML versions of both the 'Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine' and the 'Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine' are now available.
3 December 2020
A note regarding the ingredients has been added as well as an accessible HTML version of 'Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine'. A reference to the Medicines Act 1968 has been corrected.
2 December 2020
Added new document: Conditions of Authorisation for Pfizer BioNTech COVID-19 vaccine.
2 December 2020
First published.