The Medicines and Healthcare products Regulatory Agency (MHRA) 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 vaccines.

Most people who receive the vaccine should not 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 vaccine 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 (mhra/swineflu), allowing fast, real-time surveillance of possible side effects.

MHRA Chief Executive Kent Woods said, "The MHRA's first and main priority is to promote and safeguard public health. Even when the balance of benefit and risk is overwhelmingly favourable, as for the swine flu vaccine, we are committed to rapid evaluation of all new information.

"Our robust systems enable real-time safety monitoring and we encourage people to use the Swine Flu Portal to enable quick and effective analysis. We will make this information available to the public regularly on our website."


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