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.
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.