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Decision

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

Information for healthcare professionals and the public about Spikevax

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
8 January 2021
Last updated:
20 October 2023
Show all updates

  1. - Update to SmPC and PIL text on myocarditis and pericarditis. - Update to SmPC text on use in immunocompromised individuals. - Update the SmPC and PIL to include mechanical urticaria as an adverse event.

  2. Shelf-life of the product for Spikevax bivalent BA.4-5 Original/Omicron information updated.

  3. Product information has been updated to reflect the authorisation of the Moderna vaccine (Spikevax) for use in those aged 6 months to 5 years.

  4. Updated SmPC & PIL to reflect - Extension of indication to 6-11 y+ immunogenicity.

  5. - Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) - Update the SmPC and PIL to include urticaria as an adverse event - Update the SmPC and PIL to include extensive swelling of the vaccinated limb as an adverse event - Update the SmPC and PIL to include heavy menstrual bleeding as an adverse event - Minor change to SmPC text on myo/pericarditis

  6. Shelf-life instructions updated in SPC (sections 6.3 & 6.4) and PIL. Storage instructions changed from “-25ºC to -15ºC” to “-50ºC to -15ºC.

  7. We have updated the product information for the Moderna COVID-19 vaccine (also known as ‘Spikevax’) to include a warning regarding the risk of flare-ups of capillary leak syndrome (CLS) in individuals who already have CLS. The batch site address and the Marketing Authorisation Holder (MAH) address in the product information has also been updated.

  8. Update to PIL - to allow for heterologous boosting and to shorten the dose interval between the primary course and booster dose from at least 6 months to at least 3 months.

  9. This is a change to the Summary of Product Characteristics to allow for third dose heterologous boosting (i.e. someone having a different vaccine to their primary course as a booster) and shorten the interval between the primary course and booster dose from at least 6 months to at least 3 months. The patient information leaflet has not been changed.

  10. The website decision page for the mRNA COVID-19 vaccines has been updated to reflect the fact that the 15-minute observation period following vaccination has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction.

  11. Updated Spikevax PIL and SPCs

  12. Updated SmPC and PIL.

  13. Updated SmPC and PIL - Frozen storage instructions

  14. SMPC & PIL updated

  15. Text added:The 15-minute observation period following a vaccination with COVID-19 vaccine Pfizer/BioNTech or Moderna will be temporarily suspended as part of measures to increase the booster rollout. Regulatory documents remain unchanged.

  16. Changes to the product information

  17. 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.

  18. 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

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

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

  21. 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.

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

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

  24. 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.

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

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

  27. First published.

Documents

Last updated 15/9/23 - Summary of Product Characteristics for Spikevax 0.1 mg/mL dispersion for injection

PDF, 683 KB, 24 pages

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

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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.

Last updated 15/9/23 - Patient Information Leaflet for Spikevax 0.1 mg/mL dispersion for injection

PDF, 331 KB, 9 pages

Last updated 15/9/23 - Summary of Product Characteristics for Spikevax 0.2 mg/mL multidose vial

PDF, 660 KB, 21 pages

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

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Last updated 15/9/23 - Patient Information Leaflet (PIL) for Spikevax 0.2 mg/mL multidose vial

PDF, 284 KB, 9 pages

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Summary of the Public Assessment Report for Spikevax

HTML

Public Assessment Report for Spikevax

PDF, 200 KB, 7 pages

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Details

The 15-minute observation period following vaccination with the mRNA COVID-19 vaccines has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice. This follows careful review of the safety data by the MHRA and advice from the government’s independent Commission on Human Medicines. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. A temporary suspension will also apply for infants and children aged 6 months to 5 years, should this age group be included in the vaccination programme.

The product information for the Spikevax bivalent Original/Omicron booster vaccine can be found on a separate page.

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 (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 Marketing Authorisation (MA) 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 MA granted by the EMA on 6 January 2021. This MA 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.

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