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Influenza Vaccine

Volume 477: debated on Thursday 12 June 2008

To ask the Secretary of State for Health (1) how many people died in each trust as a result of receiving an influenza vaccine in each of the last five years; (209176)

(2) how many people were admitted to hospital in each trust as a result of receiving an influenza vaccine in each of the last five years.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating and monitoring the safety of medicines and vaccines.

An important source of information that the MHRA uses to monitor the safety of medicines and vaccines is through the receipt of spontaneous reports of suspected adverse reactions via the Yellow Card Scheme (YCS), by health care professionals and patients. This enables new or changing safety issues to be promptly detected.

The number of people in the United Kingdom whose death or hospitalisation was suspected to be associated with influenza vaccination and reported to the MHRA via the YCS is provided by year since 2003 in the following tables. It is not possible to further break these data down by individual trust.

Number of suspected adverse drug reaction (ADR) reports associated with influenza virus with a fatal outcome, received for the time period 1 January 2003 to 31 May 2008 broken down by year

Year of receipt

Number of reports

2003

2

2004

5

2005

7

2006

3

2007

5

20081

1

Total

23

1 Data for 2008 include ADR data from 1 January 2008 to 31 May 2008

Number of suspected ADR reports associated with influenza virus where the reporter has stated the ADR to be serious for the following reason: “Involved or prolonged patient hospitalisation”, for the time period 1 January 2003 to 31 May 2008 broken down by year

Year of receipt

Number of reports

2003

19

2004

27

2005

21

2006

29

2007

21

20081

6

Total

123

1 Data for 2008 include ADR data from 1 January 2008 to 31 May 2008.

It is important to note that the reporting of a suspected adverse reaction does not necessarily mean that it has been caused by the vaccine—because the reports are based on suspicions, no causal link may be established. While some reported suspected adverse reactions may represent true reactions to a vaccine, others may represent illnesses unrelated to vaccination that occur naturally in the population of vaccine recipients or concomitant medicines, and their timing in relation to vaccination may be purely coincidental.

Given that approximately eight million people who are elderly or at high risk of severe cardiac and respiratory illness are likely to be vaccinated with influenza vaccine over the winter season each year, it is inevitable that some patients may die or be hospitalised shortly after vaccination. These events may be reported via the YCS even if the temporal association with vaccination was coincidental.

The seasonal flu vaccine is safe in the vast majority of those who are vaccinated. The balance of benefits to risks of the influenza vaccines remains overwhelmingly positive.

To ask the Secretary of State for Health what influenza vaccines his Department has purchased; from which producers they were purchased; what quantities of each have been purchased; and if he will make a statement. (209201)

The Department purchased 25,000 doses of seasonal flu vaccine in 2007-08 from Solvay and Wyeth. The quantity of vaccine by supplier is commercially confidential information.

The vaccine was purchased for use in the Poultry Workers Seasonal Flu Programme. Vaccine for the routine seasonal flu programme offering the vaccine to those aged 65 years and over and those in risk groups is purchased by general practitioners rather than the Department.