Decision

Regulatory approval of Spikevax (formerly COVID-19 Vaccine Moderna)

Information for healthcare professionals and the public about Spikevax

Documents

Public Assessment Report for Spikevax

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Details

Information about the Spikevax vaccine (formerly COVID-19 Vaccine Moderna), approved by the MHRA on 8 January 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 European Medicines Agency’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. Spikevax is authorised in Northern Ireland under the CMA granted by the EMA on 6 January 2021. This CMA has similar requirements to that granted by the MHRA.

See further information in our press release.

Ingredients

The MHRA can confirm that Spikevax 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 Moderna.

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 Moderna.

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 Moderna.

Published 8 January 2021
Last updated 20 August 2021 + show all updates
  1. Summary of Product Characteristics: 1. Section 6.3 was updated to specify that of the 30 days the unopened vaccine must be refrigerated at 2 to 8°C, 12 hours of this period may be used for transportation. 2. Section 6.3 was updated to extend the length of time the unopened vaccine may be stored at 8 to 25°C from 12 hours to 24 hours. 3. A clarification was added to Section 6.3 in the 'punctured vial' section. 4. Section 6.4 was updated to say that the vaccine should not be stored on dry ice below 50°C (a change from 40 °C) 5. A new section was added to Section 6.4 titled 'Transportation of thawed vials in liquid state at 2°C to 8°C'. 6. Section 6.6 was updated to state that the stopper of each vial should be pierced at a different site for each of the ten doses that can be withdrawn from the vial, and to say that thawed vials and syringes can be handled in room light conditions. 7. New graphics were added to Section 6.6 Patient Information Leaflet: 1. 'Tenderness' was added to the following 'very common' side effect in Section 4: swelling of the underarm gland 2. The section for healthcare professionals in the PDF was updated in line with the changes to SMPC.

  2. Changes were: -Changing of name from COVID-19 Vaccine Moderna to Spikevax -Updating SMPC and PIL to say authorised in individuals aged 12 years and over -Added summary of safety profile in clinical trial participants aged 12-17 years of age -Added dizziness as an uncommon side effect -Added hypoaesthesia as a rare side effect -Added delayed injection site reaction as a common side effect -Added summary of clinical efficacy in individuals aged 12-17

  3. Updated the Summary of Product Characteristics and the Patient Information Leaflet to include a warning about myocarditis and pericarditis

  4. Added an updated Public Assessment Report following grant of Conditional Marketing Authorisation.

  5. The Information for Healthcare Professionals and Information for UK Recipients documents were replaced with a Summary of Product Characteristics and Patient Information Leaflet, respectively, following grant of Conditional Marketing Authorisation. The Conditions of Authorisation document has been removed and the Public Assessment Report will be updated in due course.

  6. Published the Public Assessment Report for Moderna COVID-19 vaccine, and a HTML summary of the report.

  7. Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing.

  8. Clarification of the quantity of doses in the vials in both the Information for Healthcare Professionals and Information for UK Recipients PDFs and HTML documents.

  9. Added 'Conditions of Authorisation for COVID-19 Vaccine Moderna' PDF and HTML documents

  10. Added a note on the ingredients of the vaccine, signposting to where in the documents more information can be found.

  11. First published.