Regulatory approval of COVID-19 vaccine VidPrevtyn Beta
Information for healthcare professionals and the public about the COVID-19 vaccine VidPrevtyn Beta.
Documents
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 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 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 vaccinees post-injection:
- VidPrevtyn Beta should be stored in a refrigerator at 2°C to 8°C. 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 stable at 23-27°C for up to 6 hours.
- Recording of information by vaccinators for product traceability purposes should capture information that would allow traceability of both the antigen and adjuvant components.
- The Commission on Human Medicines has recommended that the 15-minute observation period described in the product information for VidPrevtyn Beta can be waived for all vaccinees, except for those with a prior history of hypersensitivity to COVID-19 vaccines.
Ingredients
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 VidPrevtyn Beta.
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 Vidprevtyn Beta.
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 VidPrevtyn Beta.
Last updated 20 April 2023 + show all updates
-
MHRA comments on the handling of handling of VidPrevtyn Beta and the need for observation of vaccines post-injection, have been added.
-
Added the HTML versions of the SPC and PIL
-
First published.