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Spikevax bivalent {black_triangle}

Active Ingredient:
elasomeran, imelasomeran
Company:  
Moderna Biotech UK Ltd See contact details
ATC code: 
J07BN01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) Letters to HCPs HCP Med Info
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Important information for Healthcare Professionals

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Correct dosing of Spikevax bivalent booster vaccine-28Nov2022

{healthcare_pro_orange} For Healthcare Professionals

Moderna has received reports of accidental underdosing of the Spikevax bivalent booster vaccines, where a 0.25 mL dose (equivalent to 25 µg) was administered instead of 0.5 mL (50 µg). In most cases, underdosing was due to dose confusion, since the booster dose volume for the original monovalent Spikevax vaccine used earlier in 2022 was 0.25 mL (equivalent to 50 µg). • Spikevax bivalent booster vaccines have recently been approved by MHRA for use in individuals 18 years of age and older. The correct dose is 0.5 mL (50 µg).

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Spikevax▼ bivalent Original / Omicron BA.1 (50 micrograms/50 micrograms) dispersion for injection (elasomeran / imelasomeran): Temporary supply of product with different carton and multidose vial labels - GB Marketing Authorisation number PLGB 53720/0004

{healthcare_pro_orange} For Healthcare Professionals

The initial supply of “Spikevax bivalent Original / Omicron” will have a different tradename (in particular the word “Bivalent” is not included), and different carton and vial labels to the licensed product, and will consist of: o Batches of vials containing 2.5 mL (5 doses) entering the supply chain from mid/end August onwards o A batch of vials containing 5 mL (10 doses) entering the supply chain from end of August o Both 2.5 mL and 5 mL vials may be circulating in the supply chain at the same time, but these batches will only differ in fill volume/number of doses per vial • To ensure continuity in supply, the MHRA has agreed for these batches to be supplied to market initially via Batch Specific Variations and later under Regulation 266 of the Human Medicines Regulations (HMR) 2012, and therefore they are approved to be used as licensed product. • An exemption granted in accordance with regulation 266(4)(a) and (b) of the Human Medicines Regulations (HMR) 2012, exempts the Marketing Author

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Spikevax▼ bivalent Original/Omicron BA.1 (elasomeran / imelasomeran) – Important shelf-life update when stored at ultra-low-temperature conditions – Marketing Authorisation number PLGB 53720/0004 (3April2023)

{healthcare_pro_orange} For Healthcare Professionals

• On 31st March 2023, a new shelf-life at ultra-low-temperature storage conditions (–50ºC to –15ºC) was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for ‘Spikevax bivalent Original / Omicron BA.1’ • Alternative storage conditions have been added to the Summary of Product Characteristics (SmPC), allowing extension of the shelf-life from 9 months to 12 months in certain circumstances • Extension of the labelled 9-month shelf-life by a further 3 months (to 12 months) is possible when the product has been stored at –50ºC to –15ºC without interruption for 9 months. However, this change results in a reduction of the time allowed for use under the short-term storage conditions (i.e., from 2°C to 8°C) from 30 days to 14 days • As such, settings in possession of product stored within these ultra-low-temperature conditions can use it for up to 3 additional months beyond the printed expiry date (for a total of 12 months), provided that once thawed and placed at 2°C to 8°C, the unopened v

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Moderna Biotech UK Ltd
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Address
Moderna Biotech Distributor UK Limited, 54 Portland Place, London, W1B 1DY, UK
WWW
https://modernatx.com/en-GB
Medical Information Direct Line
0800 085 7562
Medical Information e-mail
[email protected]