Thousands of flu doses recalled over adverse reactions

By Stephen Robinson, 27 October 2011

Around 37,500 doses of the UK's only egg-free vaccine have been recalled after concern over adverse reactions.

The MHRA said all stocks of Preflucel vaccine in the UK should be returned to the manufacturer Baxter via distributors.  This follows a higher than expected frequency of reports of adverse reactions among patients.

The DoH said replacement low-egg content vaccines were available and safe to administer to this group of patients.

The recall of the UK’s only egg-free vaccine for allergic patients means GPs must now send those with severe egg allergy to hospital instead of vaccinating them in practices.

Patients who have confirmed anaphylaxis and patients who have egg allergy and uncontrolled asthma should be referred to hospital specialists. However, GPs can administer low-egg content vaccine to other egg allergic patients in primary care.

Baxter issued the recall for batch number VNV5L010C, which accounts for around 37,500 doses in the UK and 300,000 across Europe. These were distributed in early September.

The DoH has updated its Green Book of immunisation against infectious disease to reflect the recall, including a list of low-egg content flu vaccines available in the UK.

A spokeswoman said: ‘As a precautionary measure, the manufacturer of the vaccine made specifically for people with egg allergies, has withdrawn the batch.

‘This is because there have been a slightly higher number of mild adverse reactions than expected. This will not result in those suffering from egg allergies missing out on their flu vaccine – we have alternative vaccines that are safe to use.’

Patients who had already received the vaccine have ‘no need to worry’, she said.

A DoH letter to GPs and other health professionals said Baxter and regulators were investigating the cause of the adverse reactions, which have been ‘mostly mild’.

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