Flu vaccines recalled

Two batches of flu vaccine are recalled by manufacturer Novartis, following a request by the UK's medicines watchdog.

The MHRA said there was no need to revaccinate people who have received the vaccine being recalled
The MHRA said there was no need to revaccinate people who have received the vaccine being recalled

The MHRA asked the company to undertake a 'precautionary recall' of two batches of Agrippal vaccine, but stressed there was no evidence of safety concerns.

The recall came after visible 'protein aggregates' were detected in one batch for the Italian market during a routine inspection by Novartis. The company said it had availability to replace all recalled doses.

An MHRA statement said: 'At the request of MHRA, Novartis Vaccines and Diagnostics is executing a precautionary recall of the above batches.

'Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches.'

The MHRA said there was no need to revaccinate people who have received flu vaccine from these batches. Remaining stocks should be quarantined and returned to the original supplier, it said.

A spokeswoman for Novartis said: 'During a routine pre-release quality analysis of one batch of Agrippal for the Italian market, Novartis identified visible protein aggregates in one batch of vaccines which was not released to the market.

'The protein aggregates are not uncommon in vaccines and have no impact on their safety or efficacy. Individuals already vaccinated with Agrippal in the UK should not be concerned and there is no need for revaccination.'

The affected batch numbers are 126201A and 126102. Both contain pack sizes of 10 pre-filled syringes with the expiry date of 31 May 2013, and were first distributed on 9 and 17 October 2012 respectively.

The recall comes after manufacturer Crucell voluntarily halted deliveries of two batches of flu vaccine to the UK in October on patient safety grounds.

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register

Already registered?

Sign in

Just published

BMA demands urgent PPE solution after 50 Italian doctors die from COVID-19

BMA demands urgent PPE solution after 50 Italian doctors die from COVID-19

The government must act urgently to protect NHS staff amid a wave of COVID-19 deaths...

Essex GP confirmed as first NHS doctor killed by COVID-19

Essex GP confirmed as first NHS doctor killed by COVID-19

A 76-year-old Essex GP has been confirmed as the first NHS doctor to die after being...

4,000 GP practices asked to join COVID-19 research project

4,000 GP practices asked to join COVID-19 research project

GP practices using EMIS clinical systems have been urged to join a new COVID-19 research...

Coronavirus: Resources to help GPs manage high-risk and vulnerable patients

Coronavirus: Resources to help GPs manage high-risk and vulnerable patients

GPonline highlights information for different groups of patients and those with specific...

Free learning for GPs and nurses returning because of coronavirus

Free learning for GPs and nurses returning because of coronavirus

MIMS Learning has launched a free learning plan for GPs and nurses who are returning...

Almost 4,000 GPs rejoin GMC register as COVID-19 deaths surge

Almost 4,000 GPs rejoin GMC register as COVID-19 deaths surge

Around 3,800 GPs have rejoined the medical register barely a week after the government...