30 March 2020
We are working hard to support efforts to tackle the virus, maintain the welfare of our employees and ensure we continue to get our medicines, vaccines and healthcare products to patients and consumers.
The use of an adjuvant is of particular importance in a pandemic situation, as it can reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and made available to more people. Squalene is an essential ingredient of our adjuvant system. The squalene commonly used in the pharmaceutical industry is extracted from fish oil (liver) as a by-product from fishing; the production of squalene for use in vaccines is not the main driver of these fishing activities. The amount of squalene needed to manufacture doses of our adjuvant system represents a very small proportion of the animal-derived squalene used worldwide. Research to explore viable alternatives of fish-derived squalene for future use in vaccines is ongoing, including sources from plants or a full synthetic approach. Such alternatives will not be available for the ongoing pandemic.
We are closely monitoring all parts of our supply chains, proactively developing contingency plans to help us respond to the situation.
We have taken a number of measures to support supply of our products, including: prioritising medically critical products; building capacity to respond faster to unpredictable demand in some of our key consumer healthcare products; and working with logistics service providers to find alternative distribution routes.
We are experiencing some delays with distribution and delivery of our products to customers as countries around the world introduce different virus containment measures, such as border closures and flight suspensions.
Our focus is to avoid or minimise any potential delivery delays or disruptions, closely monitor what is happening and keep our customers informed.
Our priority is the safety and well-being of those who support and participate in our trials and our employees. As such, we are implementing proactive measures to protect the safety of study participants, staff at our clinical trial sites and our employees while ensuring regulatory compliance and the scientific integrity of our clinical trials.
At this time, GSK remains supportive of enrolling new patients into ongoing clinical studies, provided that investigators are confident they will be able to conduct the protocol specified safety and efficacy monitoring required for each study.
There may be exceptional cases that require GSK to pause individual trial enrollment. Such decisions will be taken on a case by case basis considering the therapeutic area and the patient population involved in the clinical study.
For new clinical trials, and as appropriate, GSK will delay study initiation and re-evaluate as the situation evolves.
For clinical trials for vaccines, given the specific benefit / risk considerations pertinent to clinical trials with prophylactic vaccines, GSK has decided to pause recruitment of additional trial participants on a country by country basis until further notice as we continuously assess the evolving situation COVID-19 situation.
People who work in manufacturing, making and distributing our products, and those who undertake business critical activities in R&D, are all working at our sites, which remain open. All other people working at GSK are working from home.
We have directed our sales force teams in the US, UK and elsewhere to suspend all face-to-face interactions and refrain from visits to clinical offices and healthcare centres. Some sales representatives may provide our customers with virtual meeting opportunities to provide support and ensure adequate supply and access to resources such as samples and planned educational programmes as appropriate.
GSK is donating $10 million to the COVID-19 Solidarity Response Fund, created by the UN Foundation and World Health Organization (WHO), to support WHO and partners to prevent, detect, and manage the pandemic, particularly where the needs are the greatest. Amongs its objectives, the fund will enable distribution of essential supplies such as personal protective equipment (PPE) to frontline health workers. GSK is also donating surplus reagents to support diagnostic testing to several countries and is preparing to do the same for surplus PPE.
GSK has also initiated new volunteering processes for people working at the company, to enable those with medical expertise to provide support to frontline health workers, whilst at the same time ensuring we protect supply and development of our medicines and vaccines. Initiatives have also been started to use salesforce personnel to help with delivery of PPE and testing equipment, and for specialists, such as procurement leaders, to work with national governments on developing supply chains.
