Responding to incidents

Alongside its planned activities in support of biological medicines, a vital element of NIBSC’s mission is to respond to emerging issues and needs related to biological medicines. Over the past 5 years, NIBSC has been called on many times to help with emerging problems and provide advice and support.  Some examples are as follows:

Pandemic influenza

Pandemic influenza remains one of biggest risks to human health identified by countries all round the world, and for this reason WHO has established an international surveillance and response network, GISRS (Global Influenza Surveillance and Response System) designed to identify and respond rapidly to emerging threats.  Cases of influenza caused by non-circulating strains have continued to occur regularly around the world over the past five years; they include avian influenza viruses of subtype H7N9 (appearing in 2013) and H5N1 (first appearing in 1997, but continuing to cause disease and death in 2014) which have a high fatality rate in humans and, in the case of H5N1, are a risk for poultry.  Fortunately these have not resulted in pandemic disease, but in 2009 a novel antigenically distinct H1N1 strain (H1N1pdm09) did spread rapidly in humans, causing a global pandemic. 
NIBSC has continued to play a key role in GISRS.  Engineered virus strains with high growth and low pathogenicity suitable for vaccine production, have been prepared for potentially pandemic H5 and H7 viruses, together with associated reagents for assay of vaccine potency, and supplied to manufacturers for pandemic planning and preparation.  In addition NIBSC responded immediately to the emerging 2009 H1N1 pandemic through rapid (within a month) supply of candidate vaccine strains to global manufacturers, one of which went into large scale production, and also through preparation and distribution of potency reagents for release of vaccines.  It was notable that NIBSC was the only organisation in the world to succeed in preparing H1N1 serum reagents, which were critical for the potency assay.  These were supplied globally to support vaccine production.   In addition NIBSC scientific staff played an important advisory role in the UK pandemic response, and their work drew high praise internationally.

Heparin: contamination with oversulphated chondroitin sulphate.

Between 2007-2008, there were a number of deaths and adverse drug events in the US and in Europe related to heparin. Based on the long history of work on heparin at the Institute, NIBSC provided assistance to regulators, pharmacopoeias and the industry by:

• providing appropriate reference materials to detect the contaminating substance
• carrying out investigational and base-line testing
• providing briefings and advice and working collaboratively with other public health bodies
• organising a series of international heparin workshops, involving regulators, pharmacopoeias and manufacturers
• contributing to developing a consensus on testing methods and specifications

Polio strains for vaccine development for the end game.

The last case of polio caused by a wild type 2 strain was in 1999; there has been no case caused by wild type 3 polio since November 2012. As vaccine production involves the growth of very large amounts of wildtype virus, escape from facilities after eradication is a major risk for the re-introduction of the virus. NIBSC has developed strains that can grow in culture but is not expected to grow in the human gut and therefore provide their own containment.  The strains have now been recognised by WHO as leading candidates for large scale vaccine production post-eradication.
The eradication of polio requires major support for surveillance networks and vaccine quality assessment as well as anticipation of future developments in vaccine usage. The Institute is very closely involved in this process through WHO.