Decision

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

Last updated 21/12/2023 - Summary of Product Characteristics for Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for ages 6 months to 4 years

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Patient Information Leaflet for Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for ages 6 months to 4 years

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Last updated 21/12/2023 - Summary of Product Characteristics for Comirnaty Omicron XBB.1.5 10 micrograms/dose for ages 5-11

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Patient Information Leaflet for Comirnaty Omicron XBB.1.5 10 micrograms/dose for ages 5-11

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Last updated 21/12/2023 - Summary of Product Characteristics for Comirnaty Omicron XBB.1.5 30 micrograms/dose for age 12+

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Patient Information Leaflet for Comirnaty Omicron XBB.1.5 30 micrograms/dose for age 12+

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Last updated 21/12/2023 - Summary of Product Characteristics Comirnaty 3 micrograms/dose concentrate for ages 6 months to 4 years (maroon cap)

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Last updated 08/2023 - Patient Information Leaflet for Comirnaty 3 micrograms/dose concentrate for ages 6 months to 4 years (maroon cap)

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Last updated 21/12/2023 - Summary of Product Characteristics Comirnaty 30 micrograms/dose concentrate for age 12+ (purple cap)

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Last updated 08/2023 - Patient Information Leaflet for Comirnaty 30 micrograms/dose concentrate for age 12+ (purple cap)

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Details

The 15-minute observation period following vaccination with COVID-19 Vaccine Pfizer/BioNTech or Moderna has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice.) This follows careful review of the safety data by the MHRA and advice from the government’s independent Commission on Human Medicines. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. A temporary suspension will also apply for infants and children aged 6 months to 4 years, should this age group be included in the vaccination programme.

There are four presentations of the original COVID-19 Vaccine Pfizer/BioNTech authorised for use in Great Britain, three of which are currently available and all require dilution:

  • The 30 microgram/dose presentation (purple cap)
  • The 10 microgram/dose paediatric presentation currently for 5-11 year-olds (orange cap)
  • The 3 microgram/dose paediatric presentation currently for infants and children aged 6 months to 4 years (maroon cap)

The product information for the above three presentations can be found on this page.

There is currently no GB supply of the fourth presentation and the product information for this will only be published once this supply becomes available.

All four 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 this was always intended to be a temporary arrangement. Supply of the vaccine is now in accordance with the Marketing Authorisation with all remaining Regulation 174 stocks expiring at the end of February 2022.

The archived product information for the COVID-19 Vaccine Pfizer/BioNTech authorised under Regulation 174 can also be found on this page.

The original conditional Marketing Authorisation (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 and was converted to a full Marketing Authorisation (MA) on 10 October 2022. The GB CMA was converted to a full MA on 9 November 2022.

The information for healthcare professionals and UK recipients on using the vaccine safely has been updated as new data have become available and this will continue under the MA. Please regularly check this information as it is often updated.

The MHRA regularly publishes reports of the safety of the COVID-19 vaccines.

Published 2 December 2020
Last updated 22 December 2023 + show all updates
  1. Update to section 4.8 of the SmPC to update the safety information available in 12-15 year olds.

  2. Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) of the Comirnaty Omicron XBB.1.5 vaccines have been published.

  3. Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) updated to reflect: 1. A variation to reflect new posology for primary immunisation. The updates affect all the Comirnaty Original Products. 2. A variation to extend the shelf-life. The updates affect the Comirnaty Original 10 microgram/dose and 3 microgram/dose products. Updates applicable from 24 August 2023

  4. 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.

  5. Updated Links and hyperlinks in ARCHIVE: Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine (Regulation 174) attachment

  6. 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.

  7. Updated the purple cap SmPC

  8. Updated the Comirnaty purple, orange and maroon cap SmPCs and PILs.

  9. Product information has been added for a new presentation of the vaccine for use in those aged 6 months to 4 years.

  10. 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.

  11. 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

  12. Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech (Comirnaty) updated. 2 quality specific obligations have now been fulfilled.

  13. Updated SpC and PIL for orange cap product (Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection - Shelf-life information updated.

  14. 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.

  15. Updated information to Summary of Product Characteristics and Patient Information Leaflets (Purple Cap and Orange Cap)

  16. Updated shelf life from 9-months to 12-months for Comirnaty 30 microgram COVID-19 mRNA Vaccine (purple cap). Updated SmPC and PIL.

  17. Updated 30 micrograms and 10 micrograms PIL and SMPC to include updated information on pregnancy and breastfeeding.

  18. 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.

  19. Information for Healthcare Professionals and UK recipients on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174) was updated

  20. Added HTML document for Summary of product characteristics for Comirnaty 10 micrograms/dose concentrate for dispersion for injection

  21. Added Patient Information Leaflet and Summary of Product Characteristics for COVID-19 Vaccine Pfizer/BioNTech 10 micrograms

  22. 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.

  23. The Pfizer/BioNTech vaccine (Comirnaty) Conditional Marketing Authorisation has been renewed: changes to the SmPC – section 9 and section 10.

  24. 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.

  25. 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

  26. Update to the summary of product characteristics and patient information leaflet for the Pfizer/BioNTech vaccine condition marketing authorisation documents

  27. Updated for both HCPs and public

  28. Extended vaccine shelf life from 6 months to now 9 months.

  29. 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.

  30. Updates to the Conditional Marketing Authorisation SmPC and PIL and updates to the Regulation 174 Information for Healthcare Professionals and Information for recipients

  31. Updated conditions of authorisation for Pfizer BioNTech vaccine

  32. 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.

  33. 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.

  34. Added a warning on myocarditis to the Information for UK recipients and the Information for Healthcare Professionals

  35. 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.

  36. 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.

  37. 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

  38. Added information on fevers to Section 4 of Information for UK Recipients and section 4.8 of Information for Healthcare Professionals.

  39. Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing

  40. 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.

  41. Updated HTML and PDF attachments for 'Conditions of authorisation for Pfizer BioNTech'

  42. 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.

  43. Updated guidance for Healthcare Professionals on obtaining a sixth dose from a vial.

  44. Added an accessible HTML document: Summary of the Public Assessment Report

  45. Added the Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine

  46. 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.

  47. 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.

  48. 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.

  49. Added new document: Conditions of Authorisation for Pfizer BioNTech COVID-19 vaccine.

  50. First published.