Is GSK putting into place a safety monitoring strategy? If so, what is it?
Yes. GSK monitors and evaluates adverse events that are reported for all of its medicines, including vaccines. GSK notes and strongly endorses the WHO’s position that post-marketing surveillance of the ‘highest possible quality’ is essential to ensure extensive safety evaluation of all pandemic vaccines. • Pandemrix Pandemic Influenza vaccine (H1N1)v will be assessed in clinical studies. However, it should be acknowledged that the population studied in clinical trials will be limited, due to the need to provide the vaccine to governments as quickly as possible. This means that additional studies and ongoing monitoring will be conducted once the vaccine is launched. GSK has already begun its clinical development programme involving 16 clinical trials in healthy adults, the elderly and children (including infants). GSK expects over 9,000 individuals to be involved. GSK will share results of post-launch safety and effectiveness studies among the appropriate regulatory authorities.
