Medicines Healthcare Products Regulatory Agency
AstraZeneca UK has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the printed expiry date for a limited number of batches of Fluenz Tetra nasal spray vaccines is incorrect.
Following routine testing, AstraZeneca observed that certain batches of Fluenz nasal spray vaccines dropped in potency (strength) faster than predicted once thawed. The manufacturer has since revised the expiry dates for all affected batches as a precautionary measure. These batches are safe to use and fully effective within the amended expiry date.
The MHRA keeps the safety of medicines, including vaccines, under review and acts where necessary to protect patients and the public.
Healthcare professionals and wholesalers have been alerted of this issue and have taken sufficient action to ensure that any affected batches of the nasal sprays are used ahead of their expiry date. Any unused products after the expiry dates will be quarantined for return.
In the unlikely event that the nasal spray vaccine is administered after the amended expiry date, it is possible that the vaccine may be less effective in protecting against flu.
If patients or their carers are concerned about their nasal spray vaccine or have any further questions, they are advised to contact a healthcare professional. Please report any suspected adverse reactions to the Yellow Card scheme.
Notes to Editors
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Please see our recall for further information.
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The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK, by ensuring they work and are acceptably safe. Patient safety is our top priority and all our work is underpinned by robust and fact-based