US Federal Panel Recommends FluMist For Under 5s

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Main Category: Pediatrics / Children's Health
Also Included In: Flu / Cold / SARS;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 25 Oct 2007 - 3:00 PDT

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Reports are coming in that an advisory panel to the US Centers for Disease Control and Prevention (CDC) voted on Wednesday to recommend FluMist, a seasonal flu vaccine administered as a nasal spray, for children as young as 2.

The Advisory Committee on Immunization Practices (ACIP) voted to extend FluMist, made by MedImmune Inc, now owned by AstraZeneca plc, for use with healthy children under 5 who do not have a history of wheezing or asthma, said Reuters news agency.

According to the Associated Press, the committee did not recommend FluMist instead of the more traditional flu shot, but said it was an option for young children who did not like the needle. Flu shots are still recommended for children aged 6 months to 5 years and to the over 50s.

The US Food and Drug Administration (FDA) approved FluMist for children down to the age of 2 last month. Before that it was only approved for use in healthy people between the ages of 5 and 49. FluMist is not approved for people with asthma or children under 5 with recurrent wheezing because the vaccine could make the condition worse.

ACIP's recommendations are usually accepted by government health officials and they also influence decisions made by insurance companies.

FluMist is usually given annually in one dose, except for the very first time when the patient has two doses.

FluMist is not the same as the injected flu vaccine because it is based on a weaker version of the live virus whereas the injected form is based on a dead flu virus. Patients can get a runny nose, nasal congestion, and slight fever and children with a history of asthma or wheezing should not have it.

The FDA approved FluMist on the basis of three trials involving more than 6,000 young children aged between 6 and 59 months.

Two of the trials showed FluMist was more effective than a placebo and a third showed it was more effective at preventing flu that an inactivated vaccine given by injection.

The FDA did not recommend that children under 2 years old be given FluMist because clinical trials showed this age group was at a higher risk of being admitted to hospital and developing wheezing.

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

Health officials and professionals are generally in favour of the approval and recommendation for FluMist for the under 5s because it gives parents with young children fearful of the needle another option. Also receiving a CDC recommendation means that FluMist becomes available for free to 5 million children under Medicaid and other groups, including those in low income families who are not insured for vaccinations.

ACIP also discussed recommending an annual flu vaccination program for all schoolchildren but there is concern about the strain this will put on doctors and schools. Health experts have suggested that if more children were vaccinated every year this would not only help the children themselves but it would also reduce the spread of flu in the general population.

ACIP will be talking about this idea again when it next meets in February 2008.

Click here for earlier article about FDA approval of FluMist for under 5s.

Click here for FluMist information for healthcare professionals (from the drug company).

Written by: Catharine Paddock


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