The expert panel that advises the US Food and Drug Administration (FDA) on drug approval has voted in favour of extending the use of MedImmune's live
intranasal flu vaccine, FluMist, to the under 5s, with the exception of under 2s with a history of wheezing. The FDA does not have to follow the advice of
the panel but it usually does.
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met yesterday to review the evidence on FluMist in the light of two questions,
one addressing the efficacy of the vaccine in the under 5s and the other asking whether the benefits outweigh the risks. They also made recommendations
about post-marketing studies and surveillance.
FluMist is currently approved in the US for use as a vaccine against Influenza types A and B in healthy 5 to 49 year olds only.
In yesterday's meeting the VRBPAC panel voted almost unanimously that the evidence shows FluMist to be effective in children aged 6 to 59 months.
However, because of the increased risk of complications with children who have a history of wheezing, the panel did not vote in favour of a blanket approval
for all children aged 6 to 59 months. In addressing the question "Do the safety data demonstrate that the benefits will exceed the risks of FluMist" the
panel voted as follows:
- Children between 12 and 59 months of age with no history of wheezing: voting was 9-6 (in favour).
- Children between 6 and 23 months, regardless of wheezing history: voting was 3-12 (against).
- Children between 24 and 59 months, regardless of wheezing history: voting was 15-0 (in favour).
According to the manufacturer's information, FluMist should never be given as an injection; it is a nasal spray drug.
FluMist is not suitable for:
- Pregnant women.
- Children and adolescents on aspirin or drugs containing aspirin.
- People who are allergic to any of the substances present in the vaccine, such as eggs.
- Patients with a history of Guillain-Barre syndrome or immune deficiency.
- People with chronic illnesses such as asthma and reactive airways disease.
In trials covering over 11,000 patients, the most common side effects of FluMist included: runny nose, nasal congestion, sore throat, cough, irritability,
headache, chills, vomiting, muscle aches, reduced appetite, abdominal pain, and reduced activity or feeling tired or weak.
For the 2007-2008 flu season, FluMist will be available in a new refrigerated version. The older version had to be kept in a freezer.
MedImmune Inc is about to be purchased by AstraZeneca Plc.
Flu is a contagious respiratory illness caused by various strains of the influenza virus. The illness can be mild or severe, and sometimes ends in death.
According to the US Centers for Disease Control and Prevention (CDC), the best protection against flu is to have an annual vaccination.
The CDC statistics show that, every year on average in the US, 5 to 20 per cent of the population gets the flu, more than 200,000 of whom have to be
hospitalized, and about 36,000 die from it. The people at most risk of complications are the elderly and the very young and people who are already ill with
something else when they catch it.
Click here for FDA.
Click here for Influenza Vaccine Bulletins from the US Centers for Disease
Control and Prevention (CDC).
Written by: Catharine Paddock
Writer: Medical News Today
Copyright: Medical News Today
Publication Date: 2007-05-17 02:00
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