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Pandemic flu: responding to the H1N1 outbreak

Corporate Responsibility Report 2008

Pandemic flu: responding to the H1N1 outbreak

Updated 24 August 2009.

We have been preparing for an influenza pandemic flu for many years, researching and developing pre-pandemic and pandemic vaccines, antivirals and face masks, as well as our existing antibiotics portfolio. Our preparations meant we were able to respond rapidly when a new influenza A (H1N1) strain emerged in Mexico in late April 2009.

The World Health Organization’s (WHO) decision on 11 June 2009 to move to Pandemic Alert Level 6 sent a particularly strong message to governments and other stakeholders involved in pandemic preparedness to ensure that adequate and robust plans are in place to respond to the new strain of H1N1 (known as ’swine flu’).

A collaborative global response involving governments, international organisations and businesses is needed to reduce the impact of H1N1. GSK is committed to supporting governments and health authorities around the world to respond to this challenge.

GSK’s contribution

We offer three key products to combat pandemic flu: an H1N1 pandemic vaccine, Actiprotect a face mask and Relenza, an antiviral,. We have invested over US$2 billion to expand our capacity to manufacture these products.

We believe that the global community should take steps to protect all populations, including those without resources to protect themselves. Read about our efforts to help facilitate access to Relenza and our pandemic flu vaccine in developing countries.

Prevention and treatment – our products

Prevention

Vaccines
Immediately after we received the H1N1 ’swine flu’ virus strain in late May 2009 we began production of a vaccine that will help protect people against H1N1. We were unable to begin production before this because a vaccine needs to be based on the strain that it is acting against.

We are now in full scale production at our manufacturing facilities in Canada and Germany and are working to make the vaccine available as quickly as possible. We expect to produce several hundred million doses of the H1N1 vaccine, to be delivered from September 2009 onwards. To date, GSK has received orders for 326 million doses. The vaccine is made up of an antigen (which stimulates an immune response to the virus) and an adjuvant (which helps to boost the immune response). The use of an adjuvant should help to increase the effectiveness of the vaccine and it should also mean that less antigen will be needed to produce the same amount of vaccine¹. In addition, in clinical studies with the H5N1 (avian) influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).^2,3

Delivery of the vaccine depends on gaining approval from the regulator. We are in discussion with authorities around the world to ensure the regulatory process proceeds as quickly as possible. In 2008, GSK received a European licence for a pandemic vaccine, based on a ‘mock-up’ dossier containing data on H5N1 avian flu. We anticipate that this provisional licence will speed up registration of the H1N1 vaccine, because we can quickly supplement the data in the dossier with data on the actual H1N1 pandemic strain.

We are currently in discussions with regulatory authorities to develop appropriate clinical development plans for the vaccine. The number of people studied in initial trials will be limited, because we need to provide governments with the vaccine as quickly as possible. Additional studies and ongoing monitoring will therefore be conducted once the vaccine is launched. GSK will rapidly share results of immunogenicity and post-marketing safety and effectiveness studies with the international community.

Face masks
GSK has developed Actiprotect, a face mask coated with an antiviral agent that provides a physical barrier that prevents the wearer from inhaling virus particles and kills the flu virus within one minute of contact. Actiprotect has not been tested against the pandemic (H1N1) 2009 strain. However, the mask has been shown to inactivate all influenza virus strains that it was tested against including previous strains of H1N1, H5N1, H5N9, H2N2, H3N2, and an influenza B strain.

We currently have limited manufacturing capacity for Actiprotect. We have therefore invested in increasing existing manufacturing capacity and are also seeking additional manufacturing capability through discussion with other companies.

Treatment

Relenza (zanamivir) is an antiviral that shortens the duration of flu, helping sufferers to feel better sooner. GSK has been working with governments to supply Relenza for use in a pandemic since 2003, when the global spread of avian flu (H5N1) began. Clinical tests show that H1N1 is also sensitive to Relenza.

Following the outbreak of the H1N1 strain, we contacted governments around the world to establish demand for Relenza, to ensure equitable distribution of existing supplies and to put in place a series of measures to raise production levels. As a result, we now expect to increase our annual production capacity of Relenza to 190 million treatment courses by the end of 2009. This is a more than threefold increase on our previous maximum annual capacity of 60 million treatment courses.

Relenza is registered in over 100 countries and we currently have contracts in place to supply it to more than 60 governments.

Supporting access to our pandemic flu products

Many developing country governments lack the resources to protect their populations against H1N1, and they are concerned about their ability to mount an effective, rapid response. GSK is committed to facilitating access to Relenza and our pandemic flu vaccine in all countries.

We strongly endorse the principles set out by the Gates Foundation to help guide global allocation of pandemic vaccines, and we support its message that the global community should take all steps necessary to protect all populations, including those without resources to protect themselves.

We have committed to donate 50 million doses of our H1N1 vaccine and 2 million treatment courses of Relenza to the WHO for use in developing countries.

To further ensure the vaccine is available to developing countries, and subject to the yield and existing contractual commitments, we have also allocated 20 per cent of H1N1 vaccine production capacity at our Canadian manufacturing site to developing countries. Ten per cent of our new, increased Relenza production capacity has also been allocated for developing countries. These commitments include the two donations to the WHO.

We operate a tiered-pricing policy for both our pandemic vaccine and Relenza, based on World Bank classification of countries and GAVI eligibility for the vaccine. In line with our commitments set out in March to make our branded medicines more affordable to the world's poorest people Relenza will continue to be available at not-for-profit prices to Least Developed Countries.

We remain committed to engaging in voluntary licence discussions with any companies willing to manufacture and supply zanamivir-containing products, the active ingredient in Relenza, for use in developing countries. For example, in 2006 we granted a voluntary licence to the Chinese manufacturer, Simcere, to manufacture and sell products containing zanamivir in China and a number of other countries, including all 50 of the world's Least Developed Countries.

Ensuring business continuity
We have taken steps to ensure that during a flu pandemic we can continue to supply essential pharmaceuticals and vaccines (against influenza and other serious diseases) to patients that need them. Read more about our business continuity plans.

1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580–89.

2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665

3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401.