Dr Ian Hudson, the Medicines and Healthcare Products Regulatory Agency’s chief executive, said the trial proposal was approved with extraordinary speed: “Our priority is to protect public health. Given the importance of Ebola as a risk to public health in some countries in Africa, we fast-tracked the review of the clinical trial application for this vaccine so that it was assessed and authorised by the MHRA’s experts in just four working days.”As the MHRA fast-track’s GSK’s experimental Ebola Vaccine through the first human guinea pig trials, the MHRA head (and former GSK employee of 11 years)- Ian Hudson- utters his distinct approval, despite the fact that the infamous side effects of GSK’s Seroxat have never been properly investigated by the regulators. Furthermore, Ian Hudson fails also to mention the outrage over GSK’s exploitation of the Swine Flu hysteria, and the side effects of Narcolepsy with GSK’s Pandemrix vaccine which occurred with that scandal. Also hanging in the air are GSK’s bribery scandals around the world: from China, to Poland, and Iraq to Syria. I wonder are these volunteers aware of GSK’s appalling reputation? (from dodgy dangerous drugs to fraud, corruption and general skullduggery). It will be interesting to see what happens with GSK’s Ebola Vaccine, and what potential side effects might emerge in the future for these brave volunteers. Whatever the outcome, it seems Ian Hudson has no problem endorsing the most corrupt pharmaceutical company on the planet… I suppose it is his former employer after all! When people like Ian Hudson say that their ‘priority is to protect public health’ you really have to laugh (with gallows humor). What he really means is the MHRA’s priority is to protect pharma-wealth. Your health (and mine) is really just as disposable as a lab-test-guinea pig…
First British volunteer injected with trial Ebola vaccine in Oxford
In an unprecedented move, the untested vaccine has already gone into mass production. Some 10,000 doses are being manufactured by the British drug company GlaxoSmithKline, funded by the Wellcome Trust and the UK government, which are also supporting the Oxford trial.
If the vaccine is effective, there will be supplies available to protect thousands of health workers in west Africa, who will be the first to receive it. Nobody wants a repeat of the ZMapp experience – only a dozen doses were available worldwide of the experimental drug and, controversially, they went mostly to foreign medical and aid workers.
The first British volunteer is Ruth Atkins, 48, a communications and engagement manager in the NHS from Marcham in Oxfordshire and a former nurse. She heard on the radio as she was driving home from work that volunteers were needed for a vaccine trial run by Oxford University researchers.
“I volunteered because the situation in west Africa is so tragic and I thought being part of this vaccination process was something small I could do to hopefully make a huge impact,” she said.
One hour after the vaccination, she said: “I feel absolutely fine, it felt no different to being vaccinated before going on holiday.”
Atkins is the first of 60 healthy people who will be vaccinated to find out whether the potential vaccine has any troublesome side effects. Studies involving animals have shown no ill effects so far.
The vaccine was under development by GSK – it was in the portfolio of Okairos, a smaller company bought by GSK last year – before the Ebola outbreak occurred, but it could have taken a decade to get it through the trials and into production.
There is a growing sense of urgency, with the World Bank warning on Wednesday that billions of dollars could be drained from economies in west Africa by the end of next year if the epidemic is not contained. The bank has pledged about $200m in emergency assistance to Guinea, Liberia and Sierra Leone, the three countries worst affected. The US announced on Tuesday it would send 3,000 troops to help tackle the outbreak.
Four trials of the vaccine will take simultaneously to gather enough safety data and early information on the immune response, which is an indication of whether it will protect against the disease.
Ten volunteers have already been injected in the US, where the National Institutes of Health has been funding the development of the vaccine against the Ebola Zaire strain and another against Ebola Sudan. If all goes well, there will also be trials in the Gambia and Mali in healthy volunteers.
It is hoped results from the trials will be available before the end of this year. If the vaccine is effective, it will be given to health workers in Ebola-stricken regions. This will be the only way to find out whether the it really can protect against the disease.
Prof Adrian Hill, director of the Jenner Institute at the University of Oxford, which is running the trial, said: “Witnessing the events in Africa makes it clear that developing new drugs and vaccines against Ebola should now be an urgent priority. It is tremendous that so many people have worked hard to make this trial happen in a short time, and I am enormously grateful to those volunteers who have come forward to take part and to the funders including the Wellcome Trust, DfID, MRC and MHRA for supporting this trial so quickly.
“These are initial safety trials of the vaccine and it will be some time before we know whether the vaccine could protect people against Ebola. But we are optimistic that the candidate vaccine may prove useful against the disease in the future.”
Dr Ian Hudson, the Medicines and Healthcare Products Regulatory Agency’s chief executive, said the trial proposal was approved with extraordinary speed: “Our priority is to protect public health. Given the importance of Ebola as a risk to public health in some countries in Africa, we fast-tracked the review of the clinical trial application for this vaccine so that it was assessed and authorised by the MHRA’s experts in just four working days.”