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Flu vaccines recalled

1 November 2012

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Batches of Novartis flu vaccines have been recalled by the Medical and Healthcare products Regulatory Agency (MHRA).

Two batches of the Agrippal vaccine have been recalled following detection of the presence, in one of the components, of visible protein aggregates that were identified following additional testing during the course of an investigation.

The recall is despite there being no evidence of any safety concerns or any adverse reactions being associated with the vaccines in question.

“We have asked Novartis to issue a precautionary recall of two batches of Agrippal vaccine,” said an MHRA spokesperson.

“The decision was made after the company reported quality defects with the vaccine which do not currently indicate a safety issue for those who received the vaccine. We will continue to closely monitor the situation with Novartis.

“As always, it is important that any vaccine syringes or vials are inspected before administration to ensure the colour and composition conforms to the SPC description. Vaccines that do not conform should be disposed of appropriately. If a product defect is suspected, this should be reported to the MHRA.”

A spokesperson from Novartis said the protein aggregates found in the recalled vaccines “are not uncommon in vaccines and have no impact on their safety or efficacy”.

“Agrippal currently accounts for around 10% of Novartis’ influenza vaccine provisions in the UK and Novartis’ Vaccine and Diagnostics divisionn has availability to replace all recalled doses with alternative influenza vaccine,” said the spokesperson.

It is advised that those who have administered vaccines from batches 126201A and 126102 should have “no cause for concern” and there is “no need” for revaccination.

Health professionals have been told to quarantine the remaining stocks of the “affected” batches and return them to the original supplier for credit.