The European Medicines Agency has approved GlaxoSmithKline’s pandemic swine flu jab Pandemrix and the firm says it expects to start shipping the vaccine to countries in Europe sometime next week.
The green light from regulators came just days after its advisors, the Committee for Medicinal Products for Human Use, gave Pandemrix’ marketing submission the thumbs up, and marks a ray of sunshine for the company after a rather tough few days.
GSK has this week been hit by news of the death of a 14 year-old girl shortly after receiving its cervical cancer Cervarix, although no direct link with the vaccine has been established and the girl was, according to NHS Coventry, suffering from a serious underlying medical condition that was likely to have caused the death.
Further bad news came in the form of its decision to pull the marketing application for its chemotherapy-induced and post-operative nausea and vomiting candidate Rezonic/Zunrisa (casopitant), after it emerged following a discussion with regulators that extra “time-consuming” safety studies would be needed to support the drug’s file.
And then yesterday regulators across the pond said they needed more time to assess the marketing application for Cervarix, putting even more distance between the vaccine and Merck & Co’s rival Gardasil, which was launched in the all-important US market back in 2006.
So news that the European Commission has granted GSK’s pandemic (H1N1) vaccine Pandemrix a license for the protection against swine flu will likely be very welcome indeed, particularly as it has the potential to pull in some big bucks for the firm through contracts with various governments around the globe all hoping to reduce the impact of the current pandemic.
Mock-up files
Approval of Pandemrix is based on a “mock-up” registration file using the H5N1 antigen that was given the nod in Europe last year after regulators considered it both effective and generally well-tolerated. However, the submission also included early results from clinical studies using the current H1N1 strain, such as data showing that just one dose of the vaccine provided a strong immune response “which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine”, according to the firm. In addition, initial evidence suggests that the new H1N1 vaccine has a similar safety and tolerability profile as the already approved H5N1 version.
More than 9,000 patients across Europe, Canada and the US are currently taking part in 16 clinical trials designed to further assess the efficiency and safety of Pandemrix, results of which will be given to regulators as soon as they become available, GSK noted. In the meantime, its vaccine will be shipped out to countries across Europe so that government’s can kick off their own immunisation programmes.
