Safety and supply issues around an H1N1 vaccine

July 30, 2009

An Editorial in this week's Lancet says that countries must have strong post-marketing surveillance in place forthcoming H1N1 vaccines, since countries fast-tracking the approval could bypass the usual safety and efficacy requirements. The Editorial also says the USA must support strategies proposed by WHO to make doses of the H1N1 flu vaccine go further.

On July 7, WHO's Strategic Advisory Group of Experts on Immunization recommended that vaccine formulated with oil-inwater adjuvants and live-attenuated influenza vaccines should be promoted to help increase the global supply of a vaccine and because they are better at protecting against strain variations. Yet there are signs that the USA might not follow this recommendation. "Adjuvant use would be contingent upon showing that it was needed or clearly beneficial", Jesse Goodman, acting chief scientist and deputy commissioner of the Food and Drug Administration told a press briefing on July 17. The Editorial says: "The USA must support the use of dose-sparing strategies to avoid depletion of an already short vaccine supply."

The Editorial says: "Some fear a repeat of the 1976 H1N1 outbreak in the USA, where mass vaccination was associated with complications, which stopped the campaign and led to the withdrawal of the vaccine."

It concludes: "Countries need to assess carefully the risks and benefits of rapid approval of an H1N1 vaccine, especially since the disease has so far been mild with most patients making a full recovery. They must also ensure that they have strong post-marketing surveillance in place before rolling out a vaccine."
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Lancet

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