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Decision: Regulatory approval of COVID-19 vaccine VidPrevtyn Beta

Medicines Healthcare Products Regulatory Agency

April 20
10:23 2023

Summary of Product Characteristics for VidPrevtyn Beta dispersion for injection

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Product Information Leaflet (PIL) for VidPrevtyn Beta dispersion for injection

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

Request an accessible format.
If you use assistive technology (such as a screen reader) and need aversion 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.

Details

Information about the COVID-19 vaccine VidPrevtyn Beta, approved by the MHRA on 20 December 2022.

The Summary of Product Characteristics is a description of a medicinal products 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 Marketing Authorisation (MA) granted by the MHRA is valid in Great Britain only. VidPrevtyn Beta is authorised in Northern Ireland under the MA granted by the European Medicines Agency on 10 November 2022. This MA has similar requirements to that granted by the MHRA.

See further information in our press release.

MHRA provides the following comments on the handling of VidPrevtyn Beta and the need for observation of vaccines post-injection:

  • VidPrevtyn Beta should be stored in a refrigerator at 2C to 8C. After mixing, the Summary of Product Characteristics advises returning the product to the fridge, protecting it from light and then discarding after six hours. MHRA review of quality data has shown that the mixed antigen/adjuvant for VidPrevtyn Beta is

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