Decision

Regulatory approval of COVID-19 vaccine Nuvaxovid

Information for healthcare professionals and the public about the COVID-19 vaccine Nuvaxovid.

From:
Medicines and Healthcare products Regulatory Agency
Published
3 February 2022
Last updated
22 December 2023 — See all updates

Documents

Last updated 17/11/2023 - Summary of Product Characteristics for Nuvaxovid dispersion for injection

PDF, 322 KB, 16 pages

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Last updated 10/2023 - Product Information Leaflet (PIL) for Nuvaxovid dispersion for injection

PDF, 135 KB, 7 pages

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Public Assessment Report for Nuvaxovid dispersion for injection

PDF, 2.84 MB, 57 pages

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Summary of Public Assessment Report for Nuvaxovid dispersion for injection

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Details

Information about the COVID-19 vaccine Nuvaxovid, approved by the MHRA on 3 February 2022.

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 original Conditional Marketing Authorisation (CMA) granted by the MHRA wais valid in Great Britain only. This was converted to a full GB Marketing Authorisation (MA) on 2 October 2023. Nuvaxovid is authorised in Northern Ireland under the CMA granted by the European Medicines Agency. on 20 December 2021. This CMA has similar requirements to that granted by the MHRA.

See further information in our press release.

Updates to this page

Published 3 February 2022
Last updated 22 December 2023 + show all updates

  1. - Conversion of the Conditional Marketing Authorisation to a full Marketing Authorisation (approved on 02/10/23) - To increase the shelf-life from 9 to 12 months when stored at 2 °C – 8 °C (approved on 02/10/23) - To include additional guidance for in-use stability (approved on 02/10/23) - To include a homologous booster recommendation for adolescents (approved 17/11/23) - To add new pack sizes of multidose vials (approved 16/11/23)

  2. Nuvaxovid has been approved for use as an adult booster for those aged 18 and above. The product information has also been updated to add information on additional side effects.

  3. The product information has been updated to reflect the vaccine’s approval in those aged 12 to 17.

  4. A new pdf attachment has been added - Public Assessment Report for Nuvaxovid Dispersion for Injection.

  5. First published.

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