FDA Okays FluMist Vaccine For Young Children

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Main Category: Pediatrics / Children's Health
Also Included In: Flu / Cold / SARS;  Regulatory Affairs / Drug Approvals
Article Date: 19 Sep 2007 - 12:00 PST

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The US Food and Drug Administration (FDA) announced today, Thursday, that it has approved FluMist, the nasal influenza vaccine, for the treatment of healthy young children between 2 and 5 years old.

This increases the range of patients in the US that can now be treated with the vaccine, which previously was limited to healthy children over 5 and adults up to the age of 49.

The vaccine, which is made by Maryland-based MedImmune Inc (a wholly owned subsidiary of the Anglo-Swedish drug company AstraZeneca), contains a weakened version of live flu virus and is sprayed into the nasal passages as opposed to being administered by injection.

FluMist is not approved for people with asthma or children under 5 who have recurrent wheezing because this could get worse after the vaccine.

People who are allergic to the substances in FluMist, such as eggs and egg derivatives, should also not be given the vaccine.

The US Centers for Disease Control and Prevention (CDC), recommend all children from 6 to 59 months be vaccinated against the flu.

According to research, American children under 5 are just as likely to end up in hospital because of the flu as people between 50 and 64 years of age. This, says the CDC, highlights the importance of protecting young children as well as older adults.

Director of the FDA Center for Biologics Evaluation and Research, Dr Jesse L Goodman said:

"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children."

"This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot," he added.

Until this FluMist approval, there were only two vaccines approved in the US for the under 5s: Fluzone (made by sanofi pasteur) for children over 6 months old and Fluvirin (made by Novartis) for older children, aged 4 upwards.

The approval was given on the basis of three safety and effectiveness trials where over 6,000 young children aged between 6 and 59 months were given FluMist.

Two of the trials compared FluMist to placebo, and showed it to be effective at preventing flu.

The third study compared FluMist to an inactivated vaccine given by injection. Nearly 50 per cent fewer children in the FluMist group got the flu compared to the inactivated vaccine group.

Children under 2 years old should not be given FluMist because the trials showed this age group is at a higher risk of being admitted to hospital and developing wheezing.

The most common adverse events in children aged from 2 to 6 were in the main mild and included runny nose, nasal congestion, and slight fever.

As with all medication, it is important that physicians familiarise themselves with the information provided, keep up to date with safety alerts, and check with their patients and their own records for any potential contra indications before administering the vaccine.

Click here for FDA website.

Click here for Key Facts About Seasonal Flu Vaccine (CDC).

Written by: Catharine Paddock


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