![]() Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) Updated SmPC & PIL to reflect - Extension of indication to 6-11 y+ immunogenicity. The MHRA can confirm that Spikevax does not contain any components of animal origin.Ī 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 Moderna.Ī 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 Moderna.Ī 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 Moderna. See further information in our press release. This CMA has similar requirements to that granted by the MHRA. Spikevax is authorised in Northern Ireland under the CMA granted by the EMA on 6 January 2021. 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. This is when the marketing authorisation application made by the company references the decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP). 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. It is not intended to provide practical advice on how to use this product. It explains how this product was assessed and how its authorisation was recommended, as well as its conditions of use. The Public Assessment Report ( PAR) is a scientific report, written by the MHRA. This is based on the Summary of Product Characteristics of the product. The Patient Information Leaflet provides information for patients on using the medicine safely. It is used by healthcare professionals, such as doctors, nurses and pharmacists. It explains how to use and prescribe a medicine. The Summary of Product Characteristics is a description of a medicinal product’s properties and the conditions attached to its use. ![]() Information about the Spikevax vaccine (formerly COVID-19 Vaccine Moderna), approved by the MHRA on 8 January 2021. The product information for the Spikevax bivalent Original/Omicron booster vaccine can be found on a separate page
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