Snowy Owl
Retired in 2010, In Memoriam
GSK wants to bring bird flu vaccine to Canada
Provided by: Canadian Press
Written by: HELEN BRANSWELL
Feb. 27, 2007
GAITHERSBURG, MD. (CP)
Canadians and Americans worried about the possibility of an H5N1 pandemic may eventually be able to get themselves pre-emptively vaccinated against the virulent virus.
Pharmaceutical giant GlaxoSmithKline revealed Tuesday it is exploring with Health Canada and the U.S. Food and Drug Administration how it might bring to market an H5 vaccine individuals would be able to purchase.
"GSK wants to develop a product suitable for general prophylaxis, not just (government) stockpiling," said Bruce Innis, GSK's vice-president of clinical research and development. Prophylaxis means to protect against disease by taking a protective drug or vaccine.
Innis made the comments at a meeting of an FDA advisory panel exploring issues related to the licensing and the possible advance use of H5N1 vaccine.
In an interview, Innis said there are regulatory hurdles to bringing this type of a vaccine to market in Canada. "This could be a couple of years," he admitted.
"Now one of the issues in Canada, as I understand the regulatory situation, is that currently there are not regulations in place to allow a traditional approval of a vaccine if there are no data speaking to its efficacy," Innis said.
"That's an issue that perhaps the Canadian authorities are going to have to wrestle with."
In the absence of an H5N1 pandemic, there are limits to what researchers can show about the potential efficacy of an H5 vaccine.
It would not be acceptable, for instance, to expose vaccinated people to the H5N1 virus to see if the vaccine works. So animal studies and testing of the blood of vaccinated people looking for antibodies that destroy H5 viruses are used as a proxy.
Innis said GSK is interested in mounting "large, large" clinical trials in the United States and Canada to generate the data that would show that its H5N1 vaccine could be used in advance of a pandemic to prime the immune systems of vaccinated individuals.
"If you can demonstrate long-term priming, and that that priming is likely to confer benefit and that the approach is safe, then we could put many of the concerns about pandemic influenza to rest."
FDA advised to approve U.S. bird flu vaccine
View more infection news
Provided by: Canadian Press
Written by: HELEN BRANSWELL
Feb. 27, 2007
GAITHERSBURG, MD. (CP)
Canadians and Americans worried about the possibility of an H5N1 pandemic may eventually be able to get themselves pre-emptively vaccinated against the virulent virus.
Pharmaceutical giant GlaxoSmithKline revealed Tuesday it is exploring with Health Canada and the U.S. Food and Drug Administration how it might bring to market an H5 vaccine individuals would be able to purchase.
"GSK wants to develop a product suitable for general prophylaxis, not just (government) stockpiling," said Bruce Innis, GSK's vice-president of clinical research and development. Prophylaxis means to protect against disease by taking a protective drug or vaccine.
Innis made the comments at a meeting of an FDA advisory panel exploring issues related to the licensing and the possible advance use of H5N1 vaccine.
In an interview, Innis said there are regulatory hurdles to bringing this type of a vaccine to market in Canada. "This could be a couple of years," he admitted.
"Now one of the issues in Canada, as I understand the regulatory situation, is that currently there are not regulations in place to allow a traditional approval of a vaccine if there are no data speaking to its efficacy," Innis said.
"That's an issue that perhaps the Canadian authorities are going to have to wrestle with."
In the absence of an H5N1 pandemic, there are limits to what researchers can show about the potential efficacy of an H5 vaccine.
It would not be acceptable, for instance, to expose vaccinated people to the H5N1 virus to see if the vaccine works. So animal studies and testing of the blood of vaccinated people looking for antibodies that destroy H5 viruses are used as a proxy.
Innis said GSK is interested in mounting "large, large" clinical trials in the United States and Canada to generate the data that would show that its H5N1 vaccine could be used in advance of a pandemic to prime the immune systems of vaccinated individuals.
"If you can demonstrate long-term priming, and that that priming is likely to confer benefit and that the approach is safe, then we could put many of the concerns about pandemic influenza to rest."
FDA advised to approve U.S. bird flu vaccine
View more infection news