Decision

Regulatory approval of COVID-19 Vaccine Janssen

Information for healthcare professionals and the public about the COVID-19 Vaccine Janssen

From:
Medicines and Healthcare products Regulatory Agency
Published
28 May 2021
Last updated
19 October 2023 — See all updates

Applies to England, Scotland and Wales

Documents

Last updated 26/9/23 - Summary of Product Characteristics for COVID-19 Vaccine Janssen

PDF, 880 KB, 23 pages

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Last updated 26/9/23 - Patient Information Leaflet (PIL) for COVID-19 Vaccine Janssen

PDF, 134 KB, 8 pages

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Summary of the Public Assessment Report for COVID-19 Vaccine Janssen

HTML

Public Assessment Report for COVID-19 Vaccine Janssen

PDF, 280 KB, 11 pages

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Details

Information about the COVID-19 Vaccine Janssen, approved by the MHRA on 28 May 2021.

The Summary of Product Characteristics is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

The Patient Information Leaflet (PIL) provides information for patients on using the medicine safely. This is based on the Summary of Product Characteristics of the product.

The Public Assessment Report (PAR) is a scientific report, written by the MHRA. It explains how this product was assessed and how its authorisation was recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

The original Conditional Marketing Authorisation (CMA) granted by the MHRA was approved via the European Commission (EC) Decision Reliance Route. This was valid in Great Britain only and was converted to a full GB Marketing Authorisation (MA) on 20 February 2023. COVID-19 Vaccine Janssen is authorised in Northern Ireland under the MA issued by the European Medicines Agency.

See further information in our press release.

Ingredients

The MHRA can confirm that COVID-19 Vaccine Janssen does not contain any components of animal origin.

A full list of ingredients for the qualitative and quantitative composition of the vaccine can be found at point 2 in the Summary of Product Characteristics for COVID-19 Vaccine Janssen.

A full list of ingredients for the excipient composition of the vaccine can be found at point 6.1 in the Summary of Product Characteristics for COVID-19 Vaccine Jansen.

A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Patient Information Leaflet for COVID-19 Vaccine Janssen.

Updates to this page

Published 28 May 2021
Last updated 19 October 2023 + show all updates

  1. - Update to sections 4.4 and 4.8 of SmPC and sections 2 and 4 of the PIL text to include a warning about myocarditis and pericarditis and include myocarditis and pericarditis as a possible side effect. - Update to section 4.8 of the SmPC and section 4 of the PIL to revise the frequency of some possible side effects. - Update to section 5.1 of SmPC to update the ATC code. With effect 26 September 2023.

  2. Sections 4.8 and 5.1 of the summary of Product Characteristics (SmPC) updated to include safety and immunogenicity data following a booster (second dose).

  3. Updates made to the SmPC and PIL to reflect the COVID-19 Janssen vaccine being converted to a full marketing authorisation as of 20 February 2023.

  4. - Update to section 4.8 of the SPC and section 4 of the PIL to include add facial paralysis (including Bell’s palsy) as a rare ADR - Update to section 4.8 of the SPC and section 4 of the PIL to include add cutaneous small vessel vasculitis as an ADR of unknown frequency

  5. Updates to the SPC and PIL to include information about receiving a homologous booster dose in individuals aged 18 years and over. Updates to the efficacy data included in the SPC following primary series vaccination.

  6. Updated SPC and PIL: SPC - Under "Special Warnings" section, "Guillain-Barré syndrome" section updated to include transverse myelitis. PIL - Added info on Neurological disorders - Inflamation of the spinal corrd (transverse myelitis) PIL - Added inflamation of the spinal cord to "Possible side effects" section, under "unknown" heading.

  7. Updated product information for HTML links to Summary of product characteristics and patient information leaflet. The changes are also included in the PDF attachments.

  8. Updated Summary of Product Characteristics and Patient Information Leaflet

  9. Updated the patient information leaflet for COVID-19 Vaccine Janssen

  10. Published the Public Assessment Report for COVID-19 Vaccine Janssen, and a HTML summary of the report.

  11. First published.

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