Decision

Regulatory approval of COVID-19 Vaccine Janssen

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

Applies to England, Scotland and Wales

Documents

Summary of Product Characteristics for COVID-19 Vaccine Janssen

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Patient Information Leaflet for COVID-19 Vaccine Janssen

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Public Assessment Report for COVID-19 Vaccine Janssen

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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

The Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The MHRA reviews this application, together with due consideration of the EC decision, before making an independent decision on the quality, safety, and effectiveness of the vaccine. COVID-19 Vaccine Janssen is authorised in Northern Ireland under the CMA granted by the European Medicines Agency on 11 March. This CMA has similar requirements to that granted by the MHRA.

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.

Published 28 May 2021
Last updated 12 May 2022 + show all updates
  1. 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.

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

  3. Updated Summary of Product Characteristics and Patient Information Leaflet

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

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

  6. First published.