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March 26, 2013 10:34 pm
GlaxoSmithKline is gearing up to expand its US sales of flu jabs, following a government grant for a new manufacturing plant and the likely approval of a type of vaccine ingredient.
The US Food and Drug Administration this week issued a so-called complete response letter to GSK for its request for authorisation of Q-Pan H5N1. This is a pandemic flu vaccine that includes a patented “adjuvant” – a chemical designed to boost the efficacy of the vaccine. Such letters constitute a step towards approval.
Separately, the US Department of Health and Human Services on Tuesday awarded $91m to support an influenza vaccines manufacturing centre in Texas. GSK will work at the centre with Texas A&M University on a proprietary cell-culture line called EB66, designed to supplement traditional vaccine production from chickens’ eggs.
Final approval of Q-Pan H5N1 would mark only the second time the US regulator has permitted such a new type of adjuvant in any vaccine for any manufacturer, following one granted previously to GSK for Cervarix, its HPV product to prevent cervical cancer.
The US has traditionally been reluctant to approve any new vaccine adjuvants, despite authorisation granted for them in other regions, including the EU, where the European Medicines Agency has allowed a series of such products from Novartis, GSK and other manufacturers.
That has limited GSK’s flu sales in the US, which last year were just £88m, from its Fluarix and FluLaval brands.
The decision is sensitive because the adjuvant used – called AS03 – is the same as in Pandemrix, GSK’s pandemic flu vaccine used in 2007, which some researchers have recently linked in Europe to a possible rise in narcolepsy, a sleep disorder.
It comes following a severe outbreak of seasonal flu in the US, and after evaluation of the response to the flu pandemic which highlighted the limitations of global supplies. Public health officials still believe the H5N1 “bird flu” strain is the one that offers the greatest potential threat of a future pandemic if it mutates into a form more transmissible between humans.
GSK stressed that Q-Pan H5N1 – which would only be used in the event of another flu pandemic – would be made in its plant in Quebec, while the possible link between Pandemrix and narcolepsy has only so far been identified in Europe, from production by a separate factory in Dresden. It has launched a study in Canada to see whether there is any similar connection, which is due to conclude next year.
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