Pandemic (H1N1) 2009 Influenza Update
GlaxoSmithKline (GSK) today issued an update on its progress to support governments and health authorities around the world respond to pandemic (H1N1) 2009 influenza.
Since the outbreak of the virus, GSK has shared resources and data with many authorities and governments around the world to help improve vigilance, understanding and potential responses to the virus. The company has also worked closely with the World Health Organisation (WHO) and acknowledges the leadership it has shown throughout the advancement of the pandemic.
The company has several interventions of value to help protect populations against the H1N1 influenza virus. Following more than ten years of investment in research and development of pandemic influenza vaccines, and the successful registration of its pre-pandemic H5N1 vaccine, the company is making rapid progress to produce an A (H1N1) adjuvanted influenza vaccine.
GSK has also significantly increased production levels of its anti-viral influenza treatment Relenza and developed an innovative respirator mask, designed to protect the wearer from inhaling airborne influenza virus.
GSK is committed to facilitating equitable access to all these interventions to all countries. The company strongly endorses the principles set out by the Gates Foundation to help guide global allocation of pandemic vaccines and reiterates that the global community should take all steps necessary to protect all populations, including those without resources to protect themselves.
Pandemic (H1N1) 2009 adjuvanted vaccine development
Following receipt of the virus strain at the end of May, GSK started production of an H1N1 adjuvanted vaccine and is working to ensure that the vaccine is made available as quickly as possible. Manufacture of the vaccine is dependent upon certain conditions, including yield of the influenza strain supplied by the WHO for production of antigen. As the WHO and other manufacturers have indicated the first series of strains generated for this H1N1 virus are producing relatively low yields. The WHO laboratory network is generating further strains that may provide higher yields.
The candidate vaccine will consist of two vials – pandemic (H1N1) 2009 antigen and the company’s AS03 adjuvant system, which will be combined before administration. Regulators, such as the EMEA and the FDA, will assess a generated data package including safety information, according to predefined criteria to determine approval of the vaccine.
GSK is currently in discussions with regulatory authorities to develop appropriate clinical development plans.
The total population studied in clinical trials will be limited due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.
GSK strongly supports the WHO’s call for post-marketing surveillance of the ‘highest possible quality’ to ensure extensive safety evaluation of all pandemic vaccines. GSK will rapidly share results of immunogenicity and post-marketing safety and effectiveness studies among the international community.
In clinical studies using the avian influenza H5N1 strain, use of the AS03 adjuvant in the GSK vaccine was shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant.[i] This finding, known as antigen sparing, helps to increase the number of vaccine doses that can be produced. In addition, cross protection against different avian influenza strains was observed in those clinical trials.[ii]
GSK has produced clinical data relating to its AS03 adjuvant technology and has received regulatory approvals in the European Union and some Asian countries for its pre-pandemic and pandemic H5N1 vaccines, both of which contained the AS03 adjuvant. Clinical trials in over 39,000 people have demonstrated that the AS03 adjuvant system used with an influenza vaccine has an acceptable safety and reactogenicity profile. Clinical trials are ongoing to generate additional data.
GSK has made substantial investments to expand capacity for its adjuvant system and stands ready to work with governments and regulatory agencies that may decide to combine the adjuvant system with alternatively sourced antigen.
Allocation and supply
GSK is in active discussions with more than 50 governments of both developed and developing countries, for supplies of the vaccine.
The company is on track to meet the vaccine orders placed so far by governments and to supply the WHO with an intended donation of 50 million doses of its H1N1 vaccine. So far, GSK has received orders for 195 million doses of the vaccine and first supplies of the vaccine will be available to governments from September onwards. Shipments are expected in both 2009 and 2010 and the pace of delivery will be dependant on capacity and the yield of the influenza strain.
To further ensure that the vaccine is available to developing nations, and subject to the yield and existing contractual commitments, GSK has allocated 20% of production at its Canadian manufacturing site to developing countries from early September onwards. Included within this capacity is GSK’s proposed donation of 50 million doses of the H1N1 vaccine to the WHO. Ongoing discussions with developing country governments may well lead to an increase in the percentage of output supplied to developing countries.
GSK is operating a tiered-pricing policy for its vaccine, based on World Bank classification of countries and GAVI eligibility.
Relenza (zanamivir) anti-viral treatment production
GSK has been working with governments to supply Relenza, for use in a pandemic situation, since the global spread of H5N1 which began in 2003. Relenza has typically been used to diversify and add to government stockpiles of oseltamivir (Tamiflu).
Clinical tests have confirmed that pandemic (H1N1) 2009 is sensitive to inhibitors of neuraminidase such as Tamiflu and Relenza. Following the outbreak, GSK has contacted governments around the world to ascertain demand for Relenza and has put in place a series of measures to raise production levels. As a result, GSK now expects to increase its annual production capacity of Relenza to 190 million treatment courses by the end of 2009. This represents a threefold increase to GSK’s previous maximum capacity of 60 million treatment courses.
This new capacity has been achieved by increasing production levels of Relenza Diskhaler from 60 million treatment courses to 90 million and building new capacity to produce 100 million treatment courses a year of Relenza Rotacaps. This alternative Relenza treatment was granted temporary approval by Swedish regulators earlier this month, as part of an application submitted under the European mutual recognition procedure for distribution during a pandemic. GSK is in discussions with regulatory authorities around the world to secure further approvals.
GSK has contracts in place to supply Relenza to over 60 governments. GSK has also allocated 10% of its new Relenza production capacity for developing countries. Included within this capacity is an intended donation of 2 million doses of Relenza to the WHO. GSK is also operating a tiered-pricing policy for Relenza, again based on World Bank classification of countries. In line with GSK’s commitments set out in March to make our branded medicines more affordable to the world’s poorest people, Relenza will continue to be sold at not-for-profit prices to least developed countries.
GSK remains committed to engaging in voluntary license discussions with other companies willing to manufacture and supply a Relenza product for use in developing countries.
Actiprotect anti-viral face masks
GSK has developed Actiprotect, an innovative new disposable respirator mask specifically designed with a coatingthat has antiviral effectiveness.
The mask helps protect the wearer from exposure to airborne particles during seasonal influenza A or an influenza A pandemic virus by reducing the passage of the virus through the mask and inactivating the virus on contact with the mask coating. 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.
Actiprotect has been approved for use in Europe and certain international markets and last month was approved for occupational use in the USA by the FDA. The mask has also been certified as an N95 respirator (filters at least 95% of airborne particles) by the US National Institute of Occupational Safety and Health.
GSK currently has limited manufacturing capacity for Actiprotect. The company has therefore made investments to increase its existing manufacturing capacity and is also seeking additional manufacturing capability through discussion with other companies. The company has agreements with several countries to supply the masks.
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