British drugmaker GlaxoSmithKline says it has received regulatory approval to sell its H5N1 bird flu vaccine to European countries.
The pre-pandemic H5N1 vaccine, to be sold under the name Prepandrix, will be marketed to countries seeking to stockpile the vaccine in the event of a human bird flu pandemic.
"This vaccine marks a significant step in the world's ability to cope with an influenza pandemic," GSK chief Jean-Pierre Garnier said in a release Monday.
The H5N1 strain of bird flu mainly affects birds, although the World Health Organization has reported 382 human cases of H5N1 infection from 14 countries resulting in 241 deaths, according to GSK's release. Scientists are watching for signs it has mutated into a form that transmits easily between humans, which could lead to a global pandemic.
Governments in Switzerland and Finland have both signed contracts for vaccine to stockpile, while the Untied States has said it plans to hoard enough of the drug to protect 20 million people. Canada has chosen not to stockpile immunizations, although its current contract with GSK gives it first access to any vaccine manufactured at the company's facility in Ste-Foy, Que., if a pandemic strikes.
Pre-pandemic vaccines are based on existing strains of a virus and manufactured before a pandemic lands, as compared with vaccines produced as soon as or after a pandemic is declared.
GlaxoSmithKline has previously said its vaccine would offer "a degree of protection" in the four to six months between the time a vaccine tailored to the actual pandemic strain is identified and the time production begins.
The product's shelf life is about three to five years.
The vaccine will be produced in Dresden, Germany, although the company said it intends to manufacture the pre-pandemic vaccine at its plant in Ste-Foy, which would require additional regulatory approval.
Vaccine manufactured in Quebec would be marketed in "Canada, the U.S. and other markets," said Stephen Gardner, director of the company's global vaccine policy. He didn't indicate how much the vaccine will sell for, citing government confidentiality agreements.
"We're not seeking to make a major profit from this because we realize here that governments actually in many cases want to purchase large quantities," he said. "So it needs to be affordable."
GSK is the first company to obtain a European licence for a pre-pandemic vaccine. The United States Food and Drug Administration licensed another H5N1 vaccine, made by Sanofi Pasteur, last year, although sales have been limited to the U.S.