Flu jab linked to fits in under five

[Guest guest]

Aasa already posted about this but this one is from the mainstream media (in the

UK). What isn't mentioned is that back as far as 2000, CSL had 80% market share

in Australia for Fluvax according to slide 11 in this PowerPoint presentation on

the CSL web site.

http://www.csl.com.au/docs/130/538/AnalystPresentationJune00.pdf

While they have a small market share here, it is not unreasonable to expect that

other seasonal multi-dose flu vaccines would produce similar results. Of course,

in the US pediatricians will say the seizures are unrelated to the shots ( " Kids

start having seizures all the time for a variety of reasons " ) and thus won't be

reported to VAERS.

http://www.telegraph.co.uk/health/healthnews/7918351/Flu-jab-linked-to-fits-in-u\

nder-fives-officials.html

Flu jab linked to fits in under fives: officials

Doctors should stock alternative vaccines for under fives who are due to have

the seasonal flu vaccine this winter, a letter from the head of immunisation at

the Department of Health has said.

The action is being taken as rate of convulsions caused by high fever among

children in Australia given the jab was ten times higher than normal.

Up to one in 100 children given the jab, made in Australia by CSL and marketed

in the UK by Pfizer, suffered febrile convulsions in the following hours and

days.

It is not known what is causing the problem and no other flu vaccines have been

linked to an increased risk of fits. Adults given the vaccine do not appear to

have been affected.

Children under five are only routinely vaccinated against seasonal flu if they

are in designated 'risk groups' because they have chronic asthma, have been

admitted to hospital with a respiratory infection previously or have other

long-term conditions which means they would be particularly badly affected if

they caught flu.

Seasonal flu vaccines contain three strains which have been identified by the

World Health Organisation as the most common in circulation that year. This year

the vaccines contain the pandemic strain H1N1.

The letter to all GPs from Prof Salisbury, said: " Epidemiological

information from Australia indicates that there has been a higher than expected

increase in febrile convulsions in children related to the use of Fluvax

(manufactured by CSL).

" This is the same product that will be marketed in the UK by Pfizer as Enzira

and generic influenza vaccine for the 2010/11 influenza vaccination season.

" Evidence from Australia suggests a rate of febrile convulsions of about one per

100 for children who were vaccinated with Fluvax. This increased risk appears to

be a product specific reaction and evidence from Australia of vaccination with

other products has so far not indicated a similar level of risk.

" It is important that children over six months of age who are in clinical risk

groups receive influenza vaccination. Given the availability of other influenza

vaccine products, you should avoid offering Enzira or CSL Biotherapies generic

influenza vaccine marketed by Pfizer to children aged under five years. "

He added that the medicines regulator will be monitoring the situation.

Febrile convulsions affect around one in 20 children and are normally caused by

an infection. The body reacts to the high fever with the child losing

consciousness and their legs and arms jerk. They may go pale or turn blue

briefly and after a few minutes the shaking normally stops.

The attacks can be very frightening for parents and children are usually

admitted to hospital after the first convulsion to establish the cause. Some

children are particularly prone to them but they are not normally dangerous.

In Australia, which is in its winter, stopped vaccinating all children under

five when the increased rate of convulsions was found. It has since restarted

vaccinating with other products.

A spokesman for Pfizer said: " The cause of the unexpected increased frequency of

febrile convulsions remains unknown and investigations continue. Pfizer and CSL

are working closely with regulatory authorities, health agencies and

distribution partners to determine the most appropriate way to provide influenza

vaccine for the Northern Hemisphere 2010/2011 influenza season.

" While, Pfizer supports the current precautionary approach to the use of our

influenza vaccine in children under five years of age, it should be noted that

the vast majority of patients in the UK receiving the influenza vaccine are

adults, and febrile convulsions are not seen in the adult population.

" In addition, there is no evidence that the vaccine poses any increased risks to

other groups, including pregnant women and those aged over 65.

" Pfizer and CSL are committed to ensuring the quality and safety our products.

Pfizer is in ongoing dialogue with the Department of Health to help ensure the

successful implementation of the 2010/11 Flu immunisation programme. "

A spokesman for the Department of Health said: " As part of the Australian flu

vaccination programme, a number of children were given a brand of flu vaccine

known as Enzira (Fluvax in Australia). A small proportion of these children,

aged under 5, had fits after they had this vaccine.

" The vaccine is also marketed in the UK as CSL Biotherapies generic influenza

vaccine. It contains three strains of the flu virus that experts predict are

most likely to be around this winter including swine flu (H1N1).

" We are asking GPs in the UK to avoid offering this vaccine to the under 5s in

the coming flu season, there are several other vaccines available that are

suitable for this age group. There is currently no indication that the vaccine

poses any increased risks to other groups.

" Having the flu jab remains the best protection against flu and we recommend

that people get vaccinated when they're offered it in the autumn. "