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Health
See other Health Articles

Title: Swine flu vaccine: drugs regulator casts doubt on one dose schedule (2 Doses Needed since few want it)
Source: UK Guardian
URL Source: http://www.telegraph.co.uk/health/h ... oubt-on-one-dose-schedule.html
Published: Oct 24, 2009
Author: Rebecca Smith
Post Date: 2009-10-24 15:18:43 by abraxas
Keywords: None
Views: 47
Comments: 1

Swine flu vaccine: drugs regulator casts doubt on one dose schedule

Two doses of the swine flu vaccine should be used despite British health officials deciding to give one dose in most cases, according to advice from drug regulators.

By Rebecca Smith, Medical Editor Published: 3:29PM BST 23 Oct 2009

Pandemrix, the swine flu vaccine made by GlaxoSmithKline, is already being used in Britain with health and social care workers and critically ill patients in hospital having started to receive it this week.

From next week deliveries will be arriving in GP surgeries so they can begin to offer the vaccine to pregnant women and people with long-term conditions.

BIG PHARMA ATTEMPTING TO UNLOAD THE OVERKILL.......

Government officials have advised that one dose of the vaccine is sufficient in people over the age of 10 and any children under that age who have long-term conditions should receive two doses.

Research trials have suggested that the majority of people have sufficient immunity against swine flu after one dose.

However, the European Medicines Agency's Committee for Medicinal Products for Human Use said the evidence is not strong enough to recommend one dose for general use.

In additional notes on Pandemrix the Committee said: "The vaccine should preferably be used as a two-dose schedule, but a single dose may be sufficient in adults aged 18 to 60 years. Consideration can be given to using the same one-dose schedule in adolescents and children (over the age of ten years)."

GlaxoSmithKline released data showing that in trials one half dose prompted a good immune response in children aged from six to 36 months three weeks after receiving the jab.

The Committee said on-going studies will look at how long the immune response from one dose lasts and as more data becomes available they may change the recommendations on dosing in the future.

A spokesman for GlaxoSmithKline said: "GSK’s role is to produce the safest and most efficacious pandemic influenza vaccine as quickly as possible to meet the current demand; it is the role of governments to decide individual H1N1 vaccination strategies.

"We will continue to provide regulators, health agencies and governments, new data from ongoing clinical trials, at the earliest opportunity to enable them to base their official guidance, and any revisions to this, on the latest available information.”

The British government has also bought stock of Celvapan, made by Baxter, but supplies have not yet arrived. The drugs regulator has recommended that this is also used in a two-dose schedule.

The Committee's notes on Celvapan said: "For Celvapan, while the CHMP awaits further data, the dosage schedule remains as two doses, with a three-week interval, in all populations."

A spokesman for Baxter said: "Baxter has been granted marketing authorisation for Celvapan H1N1 pandemic vaccine and the current dosing schedule calls for two doses to be given 21 days apart.

"Baxter has submitted a variation to its Celvapan H1N1 vaccine EMEA licence seeking approval for a single dose use of this vaccine. We cannot speculate on the timing of when this will be approved."

A spokesman for the Department of Health said: "The JCVI have looked at all the evidence on Pandemrix and are satisfied that one dose provides sufficient protection in adults. Any children in the priority groups will receive two doses."

Government vaccine advisors are currently looking at whether the vaccines should be offered more widely once the people in the priority groups have been offered it. The Government has ordered enough vaccine for the whole population to have two doses.

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#1. To: abraxas (#0)

Britain normally can't get doctors or nurses to take the annual jabs of flu shot.

Their usual rate is 15%-20%. Their government is trying hard to get more but it looks like the British medical staff is pretty stubborn.

TooConservative  posted on  2009-10-24   16:53:53 ET  Reply   Trace   Private Reply  


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