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
Details
InformationTo aboutdate, the COVID-19 vaccine,Vaccine approvedPfizer/BioNTech byhas MHRAbeen onsupplied 2in Decemberthe 2020.
TheUK Informationon fora healthcaretemporary professionalsbasis documentunder isRegulation a174 description of athe medicinalHuman product’sMedicine propertiesRegulations and2012, thebut conditionsas attachedthis towas itsalways use.intended Itto explainsbe howa totemporary usearrangement, andsupply prescribeof athis medicine.vaccine Itwill ischange usedto bybe healthcarein professionals,accordance suchwith asthe doctors,conditional nursesMarketing andAuthorisation pharmacists.(CMA).
The Informationproduct information for UKthe recipientsCMA documentthat provideswas informationgranted for patientsGreat Britain can be found on usingthis page. This CMA was issued by the medicineEuropean safely.Medicines ThisAgency is(EMA) basedon 21 December 2020 and was automatically converted to a GB CMA on 1 January 2021. The CMA issued by the InformationEMA forhas healthcarecontinued professionalsto have effect in Northern Ireland since 21 December 2020.
Manufacture of the product.vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine.
The publicinformation assessmentfor reporthealthcare isprofessionals aand scientificUK report,recipients writtenon byusing the MHRA.vaccine Itsafely explainshas howbeen thisperiodically productupdated wasas assessednew data have become available and itsthis authorisationwill recommended,continue asunder wellthe asCMA. itsPlease conditionsregularly ofcheck use.this Itinformation as it is notoften intendedupdated.
The toproduct provideinformation practicalfor advicethe onCOVID-19 howVaccine toPfizer/BioNTech useauthorised under Regulation 174 can also be found on this product.page while the R174 product remains in use.
FindThe outMHRA moreregularly aboutpublishes reports of the approvalsafety fromof ourthe pressCOVID-19 releasevaccines.
For further information on prioritising the first COVID-19 vaccine dose see the the statement from the Joint Committee on Vaccination and Immunisation (JCVI).(JCVI).
Ingredients
The
InformationTo aboutdate, the COVID-19 vaccine,Vaccine approvedPfizer/BioNTech byhas MHRAbeen onsupplied 2in Decemberthe 2020.
TheUK Informationon fora healthcaretemporary professionalsbasis documentunder isRegulation a174 description of athe medicinalHuman product’sMedicine propertiesRegulations and2012, thebut conditionsas attachedthis towas itsalways use.intended Itto explainsbe howa totemporary usearrangement, andsupply prescribeof athis medicine.vaccine Itwill ischange usedto bybe healthcarein professionals,accordance suchwith asthe doctors,conditional nursesMarketing andAuthorisation pharmacists.(CMA).
The Informationproduct information for UKthe recipientsCMA documentthat provideswas informationgranted for patientsGreat Britain can be found on usingthis page. This CMA was issued by the medicineEuropean safely.Medicines ThisAgency is(EMA) basedon 21 December 2020 and was automatically converted to a GB CMA on 1 January 2021. The CMA issued by the InformationEMA forhas healthcarecontinued professionalsto have effect in Northern Ireland since 21 December 2020.
Manufacture of the product.vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine.
The publicinformation assessmentfor reporthealthcare isprofessionals aand scientificUK report,recipients writtenon byusing the MHRA.vaccine Itsafely explainshas howbeen thisperiodically productupdated wasas assessednew data have become available and itsthis authorisationwill recommended,continue asunder wellthe asCMA. itsPlease conditionsregularly ofcheck use.this Itinformation as it is notoften intendedupdated.
The toproduct provideinformation practicalfor advicethe onCOVID-19 howVaccine toPfizer/BioNTech useauthorised under Regulation 174 can also be found on this product.page while the R174 product remains in use.
FindThe outMHRA moreregularly aboutpublishes reports of the approvalsafety fromof ourthe pressCOVID-19 releasevaccines.
For further information on prioritising the first COVID-19 vaccine dose see the the statement from the Joint Committee on Vaccination and Immunisation (JCVI).(JCVI).
Ingredients
The
Last
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Extended vaccine
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Updated sections of
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Added alla updates
- warning on myocarditis to the Information for UK recipients and the Information for Healthcare Professionals
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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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Added information on fevers to Section 4 of Information for UK Recipients and section 4.8 of Information for Healthcare Professionals.
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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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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.
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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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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.
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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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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.
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Added new document: Conditions of Authorisation for Pfizer BioNTech COVID-19 vaccine.
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First published.