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Information for journalists on our our approach to zika, our malaria candidate vaccine and vaccine pricing.
Malaria: PATH and GSK welcome progress toward RTS,S malaria vaccine pilot implementation with selection of countries - 24 April 2017
GSK and PATH welcome the World Health Organization’s (WHO) announcement of the countries selected to participate in the first pilot implementation of the RTS,S/AS01 malaria vaccine (also known as Mosquirix). The pilot implementation is due to begin in 2018.
The selected countries—Ghana, Kenya, and Malawi—have achieved significant reductions in malaria mortality through the deployment of currently available prevention and control measures, but still face a substantial disease burden from malaria. Each of these countries have experience with RTS,S from the large Phase 3 efficacy and safety trial of the vaccine, which concluded in early 2014.
PATH and GSK are proud to be working with WHO, the ministries of health within Kenya, Ghana, and Malawi, and other stakeholders to ensure successful implementation of the program. GSK and PATH will collaborate to donate doses of RTS,S for use in the pilot implementation.
The pilot implementation will take place on a subnational level within Kenya, Ghana, and Malawi to assess the use of the vaccine, which was positively reviewed by the European Medicines Agency (EMA), in real-life settings. RTS,S will be administrated to approximately half of the more than 750,000 participating children as part of routine medical care. WHO recommended pilot implementation to evaluate the feasibility of delivering the required four doses of RTS,S, the vaccine’s potential role in reducing childhood deaths, and its safety in the context of routine use, before considering wider-scale introduction. Pilot implementation will be complemented by the Phase 4 studies led by GSK that are part of the risk management plan agreed upon by GSK and the EMA.
The pilot implementation represents another important step toward making a malaria vaccine more widely available to children most at risk from malaria in sub-Saharan Africa.
First conceived in the 1980s, the RTS,S malaria vaccine candidate has undergone a series of studies, including a Phase 3 efficacy and safety trial that involved over 15,000 infants and young children and 11 sites in seven African countries. This trial concluded in early 2014. Since then, the data generated on the candidate vaccine have been reviewed by two leading health authorities. First, RTS,S received a positive scientific opinion from the EMA, Europe’s regulatory authority, in July 2015. Then, after a consultation process, WHO issued its position paper in January 2016, recommending pilot implementation.
RTS,S is designed to help prevent Plasmodium falciparum malaria in sub-Saharan Africa, and is proposed as a tool to complement other malaria control interventions, such as bednets, drugs, and insecticides, as well as appropriate case management. Despite progress made using currently available disease control measures, malaria remains a leading cause of death in children in sub-Saharan Africa. According to WHO, there were 212 million new malaria cases and 429,000 malaria deaths in 2015, with Africa bearing the greatest burden.Back to top
Zika: Update on GSK’s response to the Zika virus disease outbreak - 7 July 2016
Since the outbreak of Zika virus disease began in the Americas late last year, GSK has been assessing how we can best help to respond. The World Health Organisation has declared Zika and the increase in neurological disorders and neonatal malformations associated with it to be a public health emergency of international concern.
Over the past months, we have been assessing the feasibility of starting a Zika vaccine discovery programme, based on our novel vaccine technology platforms which we believe could be suitable for working on this target.
These feasibility assessments have concluded and we are now preparing research studies that will evaluate a new vaccine technology for Zika known as SAM (self-amplifying mRNA) in collaboration with the Vaccine Research Center at the National Institutes of Health (NIH) in the USA. We believe that this novel technology may have the potential to induce protective immunity against Zika. This project will be based at the newest GSK Vaccine R&D Center in Rockville, Maryland.
We will partner with research groups at the NIH to explore this concept in laboratory-based studies and, if this goes well, to accelerate our ability to transition this technology to a stage where a clinical proof of concept can be achieved.
However, vaccine research and development is a lengthy process, typically taking 10-15 years. Laboratory-based studies are the very first studies to evaluate the potential of an experimental vaccine technology before it can be tested in people.
Alongside our research efforts, we are also working with our humanitarian partners in the region, Save the Children and AmeriCares, to support prevention and education efforts which are vital to tackle the spread of the virus at a community level.
Zika, along with a number of other recent outbreaks such as Ebola, show it is essential that the world is better prepared and takes a proactive approach to identify and respond to future public health threats in advance of outbreaks to avoid devastating consequences for human health, economies and global security.
As a global leader in vaccines, GSK is committed to working with partners and governments who are keen to advance early development of candidate vaccines against potential global public health threats.Back to top
Malaria: latest news on our malaria candidate vaccine - 23 June 2016
GSK has been involved in the fight against malaria for decades. We believe that a comprehensive approach to malaria is required to scale-up use of all well established control tools, while continuing to invest in the development and use of innovative tools.
Malaria takes a devastating toll on communities and economies across Africa. The battle against the disease must be fought on all fronts using a wide range of interventions, including insecticide-treated bed nets, indoor residual spraying, effective medicines and treatments, and eventually, vaccines.
We have an active malaria research and development (R&D) programme and work hand-in-hand with organisations at the local, regional and international levels to ensure that our products complement existing malaria interventions.
UNITAID funding decision expected later this summer
GSK and PATH welcome the commitment by the Board of Gavi, the Vaccine Alliance, to provide up to $27.5 million in co-funding to the World Health Organization (WHO) for a pilot implementation programme for the RTS,S malaria vaccine candidate in sub-Saharan Africa.
This commitment comes as UNITAID’s Executive Board today indicated that providing funding towards the pilot implementation programme aligns with UNITAID’s mandate, but that any funding should be limited and proportionate. This statement paves the way for a funding decision later this summer.
Together, the Gavi and UNITAID announcements represent another critical step towards helping the world’s first malaria vaccine reach young children in Africa. PATH and GSK remain committed to working in partnership with the WHO, Gavi, UNITAID, and other stakeholders to ensure successful implementation of the pilot programme.
In support of the programme, GSK and PATH will collaborate to donate doses of RTS,S for use in the WHO pilots.
Luc Debruyne, President, Vaccines at GSK said: “Gavi’s commitment is a critical milestone in preparation for the pilot programme and in the 30-year effort to bring a malaria vaccine to the children who need it most. We believe that the potential of this vaccine to reduce the burden of disease in sub-Saharan Africa is significant and we welcome the support for the pilot programme to enable us to gain additional information about how best to deliver RTS,S in a real-world setting.”
David C. Kaslow, MD, head of PATH’s Center for Vaccine Innovation and Access and vice president for product development at PATH, said: “The results of Phase III studies demonstrated the potential public health impact of RTS,S, when used alongside bed nets and other malaria control interventions, in the setting of clinical trials. Our goal is to work, urgently, with WHO, GSK, and other partners to further evaluate the full public health impact of RTS,S—as well as aspects of both implementation feasibility and safety—when provided in a routine use setting. Although Gavi’s support is contingent on other commitments yet to be made, we are closer to that goal and a better understanding of the full public health value of RTS,S to young children in Africa”.
WHO will provide an estimated US$ 17 million in in-kind contributions and PATH, a grantee of the Bill & Melinda Gates Foundation, will receive a grant of approximately US$ 8 million towards the project. The funds committed by Gavi are for the first phase of the pilot programme and contingent upon WHO securing funding from other sources to fill the remaining gap. The pilot programme will be complementary to the follow-up Phase IV clinical studies; GSK is investing more than US$ 200 million in those studies and other remaining development costs.
Thirty-year journey to date
Global efforts have led to a 60% reduction in malaria deaths between 2000 and 2015, yet approximately 438,000 people died of the disease in 2015, the vast majority of them young children in Africa. Although existing interventions have helped to reduce malaria deaths significantly since 2000, a well-tolerated and effective vaccine with an acceptable safety profile could add an important complementary tool to existing interventions for malaria control efforts.
RTS,S is the first malaria vaccine candidate to receive a positive scientific opinion from the European Medicines Agency (EMA). According to the EMA, RTS,S “could potentially save lives in the age group most at risk from malaria”. This was followed in January 2016 by a position paper from the World Health Organization (WHO) that recommended large-scale pilot implementations of RTS,S in settings of moderate-to-high parasite transmission in Africa. Development of RTS,S has been led by GSK for more than 30 years. GSK and PATH’s Malaria Vaccine Initiative began their collaboration in 2001.
If full funding for the first phase of the pilot programme is secured by WHO, preparations could begin in several locations in African malaria-endemic countries and the first children could potentially be vaccinated in early 2018.Back to top
Pneumococcal vaccine pricing: GSK statement - 27 April 2016
For many years GSK has been working hard, in partnership with others, to develop vaccines against infectious diseases and to get them to those that need them. This is making a difference. In the last 15 years, real progress has been made in reaching children in the poorest, most remote parts of the world with life-saving vaccines.
But children still die every day from vaccine preventable diseases and so we continue to look for ways to help. We always seek to do this in a way that is sustainable – that supports access to vaccines in the long-term and not just today and that encourages governments to invest in vaccination.
Our partnership with Gavi, the Vaccine Alliance, which purchases vaccines on a large scale to protect children in the world’s poorest countries, is one way that we do this. Since 2010, we have pledged to deliver 720 million doses of Synflorix, our pneumococcal vaccine, at a deeply discounted price until 2024. Under this agreement, we offer Gavi our lowest price for Synflorix which is $3.05 per dose (equivalent to $9.15 per child).
The medical charity Médecins Sans Frontières (MSF) has called for a reduction in the price of a full course of Synflorix to $5 per child for all developing countries. We share MSF’s desire to vaccinate as many children as possible against infectious diseases no matter where they happen to be. However, Synflorix is a relatively new and very complex vaccine, combining 10 vaccines in one. It needs to be made in large, state of the art, expensive facilities. To discount it further would affect our ability to supply large volumes of the vaccine in the long-term. Nonetheless, we continuously look for ways to be more efficient and reduce our costs so that we can pass on any meaningful savings we find to Gavi.
For the rest of the world, our well-established tiered pricing policy means that we ask countries to pay a fair price that reflects their income (GNI) and rewards governments that invest in vaccination. Put simply, poor countries pay less than wealthier countries for the same vaccine.
In response to the current refugee crisis, we have committed to supply our essential vaccines at the lowest price to internationally recognised civil society organisations such as MSF to vaccinate refugees and internally displaced people. The first vaccine to be covered by this commitment is our pneumococcal vaccine, Synflorix. This helps to maintain stable vaccination programmes during times of great humanitarian need where governments are unable to assist.Back to top
Pneumococcal vaccine pricing: GSK reduces the price of Synflorix for Gavi, the Vaccine Alliance - 17 March 2016
As a demonstration of GSK’s commitment to increase access to vaccines that can help save children’s lives in the world’s poorest countries, we are pleased to offer a further price reduction for our pneumococcal vaccine, Synflorix, to Gavi, the Vaccine Alliance.
With this new offer, we will reduce the tail price of Synflorix to $3.05 USD per dose for Gavi from 2017. This is a 10% price reduction and equates to approximately $1 USD saving per child for the course of this vaccine. Pneumococcal disease can lead to pneumonia, meningitis and sepsis and is a leading cause of death in children under the age of five in developing countries.
Over the past 16 years, Gavi has played a valuable role in bringing new and under used vaccines to hundreds of millions of children in the world’s poorest countries. GSK is one of the largest contributors of vaccines to Gavi, supplying innovative vaccines for rotavirus, pneumococcal disease and cervical cancer, at significantly reduced prices to help accelerate access in developing countries.
We are keen to continue playing our part in supporting countries as they move from Gavi support due to increased economic wealth towards financing and sustaining their own immunisation programmes.
This is evident in our previous commitment to a ten-year price freeze for countries that graduate from Gavi support. We have also committed that if we identify manufacturing efficiencies, we will to pass savings on to Gavi.
Since we signed an agreement with Gavi in 2010 to provide Synflorix at a deeply discounted price, we have expanded our volume commitments, pledging to deliver 720 million doses of the vaccine up to 2024. Manufacturing at this scale has enabled us to identify incremental cost efficiencies. These have reached a threshold that we feel is meaningful and as a result we are able to offer this further $0.35 USD per dose tail price reduction to Gavi as of 2017 for Synflorix.
We believe this offer will help vaccine price stability for graduating countries, support sustainability of the Gavi model, and enable more children to benefit from national immunisation programmes.Back to top
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