Sunday, July 12, 2009

Swine flu vaccine to be cleared after five-day trial

http://www.timesonline.co.uk/tol/new...cle6690010.ece


The path of a popular medicine from the laboratory to the chemist or doctor’s surgery can involve years of clinical trials on a select group of patients.

When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days.

Regulators at the European Medicines Agency (EMEA) said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials.

The first patients in the queue for the jab - being supplied to the UK by GSK and Baxter Healthcare - may understandably be a little nervous at any possible side effects. A mass vaccination campaign against swine flu in America was halted in the 1970s after some people suffered Guillain-Barré syndrome, a disorder of the nervous system.

However, regulators said fast-tracking would not be at the expense of patient safety. “The vaccines are authorised with a detailed risk management plan,” the EMEA said. “There is quite a body of evidence regarding safety on the trials of the mock-up, and the actual vaccine could be assessed in five days.”


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Homeless people die after bird flu vaccine trial in Poland

http://www.telegraph.co.uk/news/worl...in-Poland.html

Just a test check, I wonder how long it took to make this vaccine.

The medical staff, from the northern town of Grudziadz, are being investigated over medical trials on as many as 350 homeless and poor people last year, which prosecutors say involved an untried vaccine to the highly-contagious virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

The director of a Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that last year, 21 people from his centre died, a figure well above the average of about eight.

Although authorities have yet to prove a direct link between the deaths and the activities of the medical staff, Poland's health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession.

"It is in the interests of all doctors that those who are responsible for this are punished," the minister added.