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Swine flu: second vaccine jab can give children fever, say experts

Gert van der Hoek

In Memoriam - Editor, Senior Moderator
Comment: many stories in Holland on children developing fever for 1 or 2 days after the 1st vaccination. No hospitalisations. The plan here is 2 jabs for all riskgroups, incl. young children.


Swine flu: second vaccine jab can give children fever, say experts

Government seeks advice on smaller doses after European Medicines Agency warns of temperatures topping 38C

Friday 4 December 2009 18.58 GMT

Children who have been given a second injection of the vaccine against swine flu could develop a fever, European medical officials warned today.

The European Medicines Agency (EMEA) says parents and doctors should monitor the temperature of children who have received their second dose.

The warning could lead to the Department of Health shifting position and recommending that only a single dose of the vaccine is necessary for young children.

The update has been circulated as GPs in the UK prepare to deliver the vaccine to all healthy children under the age of five. Unlike adults, children are being given two half-dose shots, three weeks apart.

The EMEA says that the "increased reactogenicity" with the second dose of the influenza vaccine Pandemrix was "unexpected as [it had not been] seen with the mock-up vaccine". It was revealed following the release of fresh data from the manufacturer, GlaxoSmithKline.

The notice says: "Parents and carers of young children (below six years of age) vaccinated with Pandemrix should be aware that fever may occur, and that this fever can be high (above 38C) [over 100.4F]. They should monitor the child's temperature after each vaccination, and give a medicine such as paracetamol to control the fever as necessary."

Adverse reactions among young children aged between six months and three years, and reported by the manufacturers, included "soreness at the site of injection, drowsiness, irritability and loss of appetite after the second dose".

The European agency did, however, conclude that a "single dose of vaccine triggered a good immune response in young children" while a second dose did bring about further protection against catching swine flu.

It also recommended that doctors continued their vaccination programme "according to the recommendations given by the health authorities in each member state".

England's chief medical officer, Sir Liam Donaldson, has warned that the under-fives are suffering particularly badly with swine flu. The flu can cause trouble with breathing.

A Department of Health spokesman said: "It's good news that such a strong response is shown after just a half-dose of the Pandemrix swine flu vaccine is given to children. Our current guidance is for children under 10 to be given two half-doses, at least three weeks apart. However, we are now asking the Joint Committee on Vaccination and Immunisation, (an independent advisory committee), for advice on whether one half-dose of the Pandemrix vaccine is sufficient. New guidance will be developed as necessary.

"The vaccine is our best defence against swine flu. More than 10 million doses of the Pandemrix vaccine have been given across the EU, including to children, and no unexpected safety concerns have emerged."

http://www.guardian.co.uk/world/2009/dec/04/swine-flu-vaccine-fever-children
 
Re: Swine flu: second vaccine jab can give children fever, say experts

Pandemrix
As of 27 November a total of 2,301 reports and 6,269 reactions have been received by EudraVigilance. According to information received from the marketing authorisation holder dated 19 November, the total number of doses distributed was 39.3 million and the total number of people vaccinated was estimated to be around 5.7 million through 17 November 2009.
* Fever, headache, nausea, vomiting, fatigue, injection site reactions, myalgia, arthralgia, paraesthesia, dizziness, pain in extremity, diarrhoea, chills, dyspnoea, malaise, cough, anaphylactic reaction and hypersensitivity have been among the most frequently reported adverse reactions since the vaccine has been authorised.
* New clinical trial data showed greater incidence of fever (above 38?C), local reactions (pain, redness, swelling) and drowsiness/irritability/loss of appetite following the second dose of Pandemrix in infants from 6 months to 35 months. An assessment of these data is ongoing.
* Since the start of use of Pandemrix as an authorised vaccine, a total of 55 case reports have been received by the EudraVigilance system which have a fatal outcome. There is no indication that the vaccine contributed to those deaths.
* EudraVigilance has received a total of 24 cumulative cases of pregnancy related events such as abortions, intrauterine deaths, stillbirths, foetal hypokinesia and premature birth. Those cases are being investigated further. There currently is no evidence of a causal link between the vaccine and reported events.
* EudraVigilance has received 26 paediatric cases of anaphylactic reactions/hypersensitivity (24 cases aged from 0 to 17 years, and 2 with age unknown). Anaphylaxis is a rare expected adverse reaction to Pandermix.
* Up to 27 November, three reports of Guillain-Barr? syndrome were received. Two were later not confirmed and one is under investigation. There is no evidence to suggest that the vaccine causes Guillain-Barr? syndrome.
* A case of heart transplant rejection from Sweden was received. Further information was requested and health authorities are seeking advice from transplant immunologists.

http://www.emea.europa.eu/pdfs/influenza/78468109en.pdf
 
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