NPC Archive Item: Safety monitoring programme up and running for swine flu vaccines

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27 October 2009

The MHRA has established a safety monitoring programme for swine flu vaccines to capture, evaluate, and monitor suspected adverse drug reactions.

Members of the public and healthcare professionals should report any suspected adverse reactions to pandemic swine flu vaccines (Celvapan▼ and Pandemrix▼) or antiviral medicines used for the treatment or prevention of swine flu (Tamiflu▼ and Relenza▼) through the dedicated online reporting website that has been set up by the Medicines and Healthcare products Regulatory Agency (MHRA).

In a press release on the 22nd October, the MHRA announced that it has extended its dedicated Adverse Drug Reaction (ADR) website for reporting suspected side effects to H1N1 (swine flu) antivirals to now include separate reports about the recently introduced H1N1 vaccines.

Most people who receive the vaccine are not expected to experience any significant side effects. As with all new vaccines, the MHRA is keen to evaluate ADR reports and encourages both members of the public and healthcare professionals to inform them of any suspected reactions.

The MHRA has an established safety monitoring programme to ensure the reports linked to the swine flu vaccines are promptly captured, evaluated and monitored against background or ‘expected’ rates.

A dedicated team of drug safety scientists are responsible for reviewing ADR reports submitted to the MHRA through the Swine Flu Portal allowing fast, real-time surveillance of possible side effects.

Further information on swine flu vaccines, including product information (patient information leaflets and Summaries of Product Characteristics is available on a dedicated webpage of the MHRA website.

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