Published 16 September 2009, doi:10.1136/bmj.b3802
Cite this as: BMJ 2009;339:b3802

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Swine flu vaccine is a "thousandfold" safer than the infection, say experts

¹ BMJ

Experts this week played down the risk of adverse effects from the forthcoming swine flu vaccine, saying that even in the worse case scenario people would be a "thousandfold better off" having the jab than the disease.

Concerns have previously been raised that the vaccine may carry a risk of causing Guillain-Barré syndrome, an autoimmune condition that attacks the peripheral nervous system, in rare cases causing permanent paralysis or death. The fears largely stem from the 1976-7 flu season in the United States, when a vaccine was withdrawn after a spike in cases of the neurological disease, but doubt has now been cast on whether the flu vaccine was actually responsible.

Robert Dingwall, director of the University of Nottingham’s Institute for Science and Society, who was speaking at a press briefing on swine flu vaccination, said that people would be more likely to get Guillain-Barré syndrome as a result of flu itself than from the vaccine. He added that the compensation claims paid out in the US would be unlikely to succeed today. "In 1976 the science was less well developed, and in the framework of the American legal system there was considerable pressure to make some payment on the basis of a possible link. Thirty years on from that it looks as if that link probably doesn’t exist and that those compensation claims probably weren’t paid appropriately," he said.

Mike Skinner, senior lecturer in virology at Imperial College in London, agreed, saying that all flu vaccines since 1976 have had an excellent safety record and that a link between Guillain-Barré syndrome and vaccination was "basically impossible at this stage to demonstrate."

Dr Skinner said that although little was known about how the syndrome develops, "it clearly is associated with infection, and it may well be that it does get more associated with a particular vaccine, but the only one we’ve seen is that one in 1976, if at all." He added: "Even if you take the worst case scenario, from the vaccine and from the infection, you’re something like a thousandfold better off with the vaccine than you would be from the infection."

Richard South, medical director at vaccine manufacturer GlaxoSmithKline’s Pandemic Centre of Excellence, said that although only a few tens of thousands people have so far received the new vaccine, it looks as though adverse reactions are "extremely rare." He cautioned against over-attributing adverse reactions, because "things happen to people that would happen anyway," especially when large numbers of people are being vaccinated.

Dr South added that new surveillance procedures have been put in place by regulatory bodies and drug manufacturers to evaluate safety, "not just the normal passive reporting of events that doctors and other healthcare professionals are encouraged to do, but also some much more active monitoring activities involving studying very clearly defined and large populations for adverse events."

Cite this as: BMJ 2009;339:b3802

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See Personal View, "Should I have an H1N1 flu vaccination after Guillain-Barré syndrome?" (BMJ 2009;339:b3577, doi:10.1136/bmj.b3577).

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