FDA delays GSK flu vaccine
pharmafile | March 27, 2013 | News story | Research and Development, Sales and Marketing | FDA, GSK, Vaccine
The FDA has cooled on GlaxoSmithKline’s latest vaccine for a bird flu pandemic, Q-Pan H5N1, despite a vote of confidence last year from one of its key advisory committees.
GSK insists the US regulator’s complete response letter, issued this week, was nothing to worry about.
The document, which often signals that the FDA does not think it has enough data to make a decision, “was triggered due to an administrative matter that has recently been rectified”.
The two parties are “actively working together to complete the review in a timely manner”, GSK adds.
Things had certainly been going well: last November, the Vaccines and Related Biological Products Advisory Committee gave Q-Pan H5N1 a clean bill of health on immunogenicity and safety.
It was a unanimous vote among the 14-strong committee and the FDA tends to follow such advice and grant full authorisation.
GSK’s candidate pandemic H5N1 adjuvanted influenza vaccine is designed as a preventative tool for adults at increased risk of exposure to the virus subtype it contains.
The US government has a strong interest in it, with GSK being given a development contract by the Biomedical Advanced Development and Research Authority, part of the Department of Health and Human Services.
Such state involvement is crucial for pharma: the US government put $487 million into the start-up costs of Novartis’ own facility used to produce H5N1 vaccine shots, for example.
But there have also been well-publicised health concerns over vaccines developed quickly in the face of global flu scares.
The European Medicines Agency has already investigated potential links between another GSK flu vaccine and instances of narcolepsy.
The single-dose drug Pandemrix was granted a fast-track authorisation and has been used since September 2009 against H1N1 influenza to deal with the flu pandemic declared by the World Health Organisation.
GSK Vaccines is headquartered in Belgium and has 13 manufacturing sites worldwide.
Adam Hill
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