GlaxoSmithKline has become the first company to obtain a European licence for a pre-pandemic vaccine, after the firm’s Prepandrix got the thumbs-up from regulators.
The European Commission has granted a marketing authorisation for the H5N1 adjuvanted pre-pandemic vaccine, Prepandrix, thus offering governments “the potential for protecting their population in advance or at the onset of an officially declared influenza pandemic”. The decision comes just over two months after the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the jab be used against the H5N1 strain, commonly known as bird flu.
The EU license is based on data from a number of trials of Prepandrix using the Vietnam strain, which demonstrated at least a four-fold increase in serum neutralising antibodies in 77% to 85% of subjects against three distinct H5N1 strain variants. The vaccine has also shown cross-protection in preclinical studies, preventing mortality in 96% of cases following two doses of adjuvanted vaccine.
The approval means that GSK is getting a headstart on Sanofi-Aventis and Novartis who are also preparing pre-pandemic vaccines.
GSK said that it has signed contracts with the USA and a few European governments, notably Switzerland and Finland, who are stockpiling and the firm sold £146 million of its pre-pandemic vaccine and bulk antigen in 2007. It has also laid out plans to donate 50 million doses to the World Health Organisation.
The firm will now be hoping that other governments start taking a more proactive stance to stockpiling as pre-pandemic vaccination “is an important strategy for addressing the current threat of a pandemic posed by H5N1”, according to Jean Stephenne, president of GSK Biologicals. He added that the company “remains committed to actively work with governments on their pandemic preparedness plans to help protect against the potentially devastating impact of a pandemic.”
To date, the WHO has reported 382 human cases of H5N1 infection from 14 countries resulting in 241 deaths.
