Swine flu vaccines get first UK trial
Researchers in Oxford have started the first trial of Britain's two swine flu vaccines.
Working with teams in Bristol, Exeter, Southampton and London, they are aiming to recruit 1,000 youngsters aged six months to 12 years. I went to the Children's Hospital at the John Radcliffe in Oxford to witness what were the first recipients of the UK's H1N1 vaccines.
Although both vaccines are likely to get licensed in the next few weeks, none of the trials has taken place in Britain. Pandemrix (made by GSK) was approved by the European Medicines Agency on Friday, while Baxter's H1N1 jab seems likely to get approved this week.
This is the first time the vaccines have been used in the UK and the first comparative study of the jabs.
Professor Andrew Pollard from the University of Oxford is heading the research:
"We are doing this trial to compare head-to-head the two vaccines which are going to be used in the UK against swine flu to see which one works best in children and which one is best tolerated. We are sort of in a race against time because we know the flu season is already started. We hope to immunise the children over the next 10 days or so. There are very few exclusions - people with immune system problems and egg-allergic children because one of the vaccines is made using egg."
The GSK vaccine is made using the traditional means of growing the virus in embryonated hens' eggs, before the virus is broken and deactivated. The Baxter vaccine is made in cell culture, so is suitable for those who have an egg allergy. Among the expected side-effects are sore arms and fevers. The information given to parents also lists rare side-effects including Guillian-Barré syndrome, which can cause ascending paralysis and even be fatal.
It's worth quoting here from the trial information:
"Other very rare events that have been seen with routine flu vaccines include seizures and temporary bleeding disorders. In the past Guillian-Barré syndrome (a rare disorder of nerves) has been associated with flu vaccines but the relationship remains uncertain, with some studies suggesting a possible link but others not finding it. One large study in the UK found that influenza-like illness itself was associated with an increased risk of the Guillian-Barré syndrome but there was no link with the seasonal influenza vaccines, suggesting that vaccination might actually protect against the disorder by preventing flu."
What I take that to mean is that, if you have the vaccine, there is a remote, theoretical possibility that you could get GBS (as happened in the USA in 1976 with their swine flu vaccine), but you are more likely to get it as a result of contracting flu. So while it is impossible to rule out the risk of GBS from the vaccine, it is very remote, and this must be balanced against the very real and proven risks of complications from flu.
I spoke to several of the parents and asked them why they had brought their children along. Considering it was the first day of the trial, it was not surprising to find several doctors who had heard about the trial.
Dr Jocelyn Hughes is an Oxford paediatrician. She brought four-year-old Susanna and two-year-old Ben to be immunised.
"I was keen to offer Susanna and Ben some protection against swine flu having seen some cases in A&E, and having the trial on our doorstep was a good way of doing that."
Nicolette Wolf brought 17-month-old Reuben to be immunised. She is pregnant and will be one of the first to be offered a swine flu jab. I wondered whether she would take it, because, in researching the Panorama on swine flu, we met several pregnant women who seemed not keen on having the jab. Nicolette feels differently:
"I will definitely take it to protect myself and obviously the baby. I know my immunity is low as a pregnant woman. I had a cold recently that really hit me and I was shocked to see how long it took to recover - so all the more reason to have the swine flu jab."
Graunya Bean brought four-year-old Liam.
"My youngest son Logan got swine flu three months ago and was really ill. He had an extreme high temperature and was refusing fluids. We had three days of being very concerned about him until he got Tamiflu. Liam has just started school and quite a few kids have come down with it there so we were concerned about him getting it, and obviously there's the benefit of them being able to do research to help others."
This clinical trial comes just a month before a UK immunisation campaign begins. More than 11 million people in Britain considered to be most at-risk from flu, such as those with asthma or heart problems, will be offered the vaccine plus more than two million front-line health workers.
Above you can see a brief interview with Andrew Pollard and one of the families on the trial.