Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.
Applies to England, Scotland and Wales
Documents
Summary of Product Characteristics forComirnaty COVID-1930 Vaccinemg/dose Pfizer/BioNTechconcentrate (purple cap)
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Patient Information Leaflet for COVID-19Comirnaty Vaccine30 Pfizer/BioNTechmg/dose concentrate (purple cap)
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Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech
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Details
The 15-minute observation period following a vaccination with COVID-19 vaccine Pfizer/BioNTech or Moderna willhas bebeen temporarily suspended as part of measures to increase the booster rollout. Regulatory documents remain unchanged.
ToThere date,are three presentations of the COVID-19 Vaccine Pfizer/BioNTech hasauthorised beenfor use in Great Britain, two of which are currently available:
- The original 30 microgram/dose presentation which needs to be diluted (purple cap)
- The 10 microgram/dose paediatric presentation currently for 5-11 year-olds, which also needs to be diluted (orange cap)
The product information for the above two presentations can be found on this page.
There is currently no GB supply of the third presentation and the product information for this will only be published once this supply becomes available.
All three presentations use the same drug substance but have specific administration requirements and are differentiated by use of different coloured caps on the vials.
Initially, the COVID-19 Vaccine Pfizer/BioNTech was supplied in the UK on a temporary basis under Regulation 174 of the Human Medicine Regulations 2012, but as this was always intended to be a temporary arrangement,arrangement. supplySupply of thisthe vaccine willis changenow to be in accordance with the conditional Marketing Authorisation (CMA).(CMA) with all remaining Regulation 174 stocks expiring at the end of February 2022.
The product information for the CMACOVID-19 thatVaccine wasPfizer/BioNTech grantedauthorised forunder GreatRegulation Britain174 can also be found on this page.page Thiswhile the R174 product remains in use.
The original CMA was issued by the European Medicines Agency (EMA) on 21 December 2020 and was automatically converted to a GB CMA on 1 January 2021. The CMA issued by the EMA has continued to have effect in Northern Ireland since 21 December 2020.
Manufacture of the vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine.
The information for healthcare professionals and UK recipients on using the vaccine safely has been periodically updated as new data have become available and this will continue under the CMA. Please regularly check this information as it is often updated.
The productMHRA informationregularly forpublishes reports of the safety of the COVID-19 Vaccinevaccines.
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pageandwhileSMPCtheComirnatyR17410productmg/doseremainsconcentrate:inupdateduse.ThetitleMHRAtoregularlyincludepublishesreportsreferenceoftotheorangesafetycap.ofUpdated theCOVID-19shelfvaccines.Forlifefurtherlifeinformationfromon6prioritisingmonths to 9 months. SMPC and PIL Comirnaty 30mg/dose concentrate: Updated title to include reference to purple cap. Includes new reference to thefirstfactCOVID-19therevaccineisdosenowseepaediatricthestatementformulation available for children 5 to 11 years of age. Myo/pericarditis changed fromtheaJointpotentialCommitteesideoneffectVaccinationofandunknownImmunisationfrequency(JCVI).
- side effect with unknown frequency. Wording around shelf life updated.
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Information for Healthcare Professionals and UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) was updated
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Added Patient Information Leaflet and Summary of Product Characteristics for COVID-19 Vaccine Pfizer/BioNTech 10 micrograms
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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.
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The Pfizer/BioNTech vaccine (Comirnaty) Conditional Marketing Authorisation has been renewed: changes to the SmPC – section 9 and section 10.
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Extended vaccine shelf life from 6 months to now 9 months.
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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.
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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.
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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.
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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
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Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing
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Updated HTML and PDF attachments for 'Conditions of authorisation for Pfizer BioNTech'
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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.
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Updated guidance for Healthcare Professionals on obtaining a sixth dose from a vial.
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Added an accessible HTML document: Summary of the Public Assessment Report
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Added the Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine
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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.
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Added new document: Conditions of Authorisation for Pfizer BioNTech COVID-19 vaccine.
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First published.
Update history
2024-03-21 12:21
The product information of Comirnaty products has been updated following recent approval on PI updates (Sections 1, 2, and 4.8, and labelling) and shelf-life extension.
2023-12-22 09:51
Update to section 4.8 of the SmPC to update the safety information available in 12-15 year olds.
2023-09-05 14:35
Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) of the Comirnaty Omicron XBB.1.5 vaccines have been published.
2023-09-01 12:56
Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) updated to reflect: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.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
2023-06-05 15:35
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.
2023-05-25 12:26
Updated Links and hyperlinks in ARCHIVE: Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (Regulation 174) attachment
2023-03-17 13:08
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.
2023-01-06 16:09
Updated the purple cap SmPC
2022-12-09 16:48
Updated the Comirnaty purple, orange and maroon cap SmPCs and PILs.
2022-12-06 10:58
Product information has been added for a new presentation of the vaccine for use in those aged 6 months to 4 years.
2022-11-09 12:47
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.
2022-08-16 10:51
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
2022-07-07 14:26
Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech (Comirnaty) updated. 2 quality specific obligations have now been fulfilled.
2022-05-24 16:40
Updated SpC and PIL for orange cap product (Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection – Shelf-life information updated.
2022-05-05 17:52
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.
2022-04-27 01:09
Updated information to Summary of Product Characteristics and Patient Information Leaflets (Purple Cap and Orange Cap)
2022-04-13 14:12
Updated shelf life from 9-months to 12-months for Comirnaty 30 microgram COVID-19 mRNA Vaccine (purple cap).Updated SmPC and PIL.
2022-03-25 11:36
Updated 30mg and 10mg PIL and SPC.
2022-03-14 15:16
PIL and SMPC Comirnaty 10 mg/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 30mg/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.
2021-12-24 01:06
Information for Healthcare Professionals and UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) was updated
2021-12-22 23:24
Added HTML document for Summary of product characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection
2021-12-22 14:43
Added Patient Information Leaflet and Summary of Product Characteristics for COVID-19 Vaccine Pfizer/BioNTech 10 micrograms
2021-12-14 16:28
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.
2021-12-03 11:33
The Pfizer/BioNTech vaccine (Comirnaty) Conditional Marketing Authorisation has been renewed: changes to the SmPC – section 9 and section 10.
2021-11-15 22:45
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.
2021-10-28 14:41
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
2021-10-27 17:50
Update to the summary of product characteristics and patient information leaflet for the Pfizer/BioNTech vaccine condition marketing authorisation documents
2021-10-27 17:50
Update to the summary of product characteristics and patient information leaflet for the Pfizer/BioNTech vaccine condition marketing authorisation documents
2021-10-27 11:56
Updated for both HCPs and public
2021-09-27 17:02
Extended vaccine shelf life from 6 months to now 9 months.
2021-06-04 11:03
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.
2021-05-20 16:29
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.
2021-03-31 17:14
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
2021-03-09 16:11
Added information on fevers to Section 4 of Information for UK Recipients and section 4.8 of Information for Healthcare Professionals.
2021-01-28 11:45
Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing
2021-01-26 17:18
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.