NVAX is being mentioned more and more. Not sure if this is some kind of pump and dump or what. They asked for the make up of the H1N1 Flu strain rather than waiting for the CDC to give it out so that they can start on the Vaccine. The thing is, are they truly a viable candidate for the vaccine, because I also see how Glaxo and some other big Pharm company are waiting for it....but they have different technology.
Suggestions and comments appreciated.
http://www.nashuatelegraph.com/apps/pbcs.dll/article?AID=/20090503/HEALTH/305039982/-1/style
Health
Published: Sunday, May 3, 2009
Anti-flu action plan Swine-flu outbreak prompts search for faster vaccine production
By LEE BOWMAN Scripps Howard News Service
The widening outbreak of a new strain of swine flu puts a renewed spotlight on technologies aimed at making influenza vaccines much faster than traditional methods.
One of the first things national and international authorities did as they determined they were dealing with a novel virus with genetic ties to flu strains found in people, North American birds, and American and Eurasian pigs was to start working on culturing the virus.
"Anytime we get a new strain, we look to create a seed stock that would be used if we decide to make a vaccine,'' said Dr. Richard Besser, acting director of the federal Centers for Disease Control and Prevention in Atlanta.
It's a standard precaution whenever a nasty new virus crops up, but also reflects the realities of vaccine production. If everything goes right, it still takes six months to get to full-scale production of a new vaccine using the standard technology of growing the virus in eggs.
It takes some 900 million eggs to make 300 million doses of the annual flu shot, or for that much vaccine against a new strain. It's a slow and sometimes difficult process, with the potential for contamination or for egg shortages to interfere. And it isn't yet known how well the new virus grows inside eggs.
There are several alternatives to egg-based vaccines in the works. Most advanced is cell-based vaccine production, which uses lab-grown cell lines, often from kidneys, that are used to host a growing virus.
The virus is injected into the cell, where it multiplies. Then the cell's outer wall is removed and the virus harvested, purified and inactivated before being put into serum.
This process is already used to produce polio vaccine and some flu vaccine in Europe. The U.S. government has contracts with Sanofi-Pasteur and Novartis subsidizing new or refurbished plants using cell technology in Pennsylvania and North Carolina, part of a master plan to increase pandemic "surge" capacity to 600 million doses of vaccine within six months of an outbreak.
And Baxter International, which also uses a cell-based production line, has announced plans to work with the World Health Organization on a swine-flu vaccine.
Another option is a recombinant virus-like particle technology, which works with insect viruses to create a "shell" that mimics the shape of a flu virus and spurs an immune response to it, but lacks the genetic material to replicate or cause infection.
Many researchers and several biotech companies have been working on this approach. Some, including the vaccine firm Novavax, have started human safety trials on their production system and have told CDC officials that they're prepared to start working with the new strain on a contingency basis.
Novavax officials say they could produce significant amounts of new vaccine in as little as 12 weeks.
Besser said last week during a teleconference that no decision has been made about starting work on a new vaccine â or possibly adding the strain to next year's seasonal flu-vaccine formula.
"It's under discussion, but it's not an easy decision,'' he said.
Government health officials are particularly cautious about developing and distributing a vaccine against swine flu because of the institutional memory of botched efforts surrounding the 1976 swine-flu-immunization program.
Officials 33 years ago feared that the virus causing an outbreak in New Jersey was a close cousin of the strain that caused the 1918-19 pandemic that claimed more than 50 million lives worldwide. Genetic testing done more recently now shows the 1976 virus likely came from birds.
But in February 1976, many health officials were convinced the country needed vaccine protection before the next flu season and started a massive project to make enough doses for everyone.
The mass inoculation reached only about 40 million Americans before the effort was cut short because hundreds suffered Guillain-Barre syndrome â a condition in which the immune system attacks the nervous system â after getting the shots.
And the swine-flu threat fizzled, with only about 200 reported cases in all.
"There's a lot that's been learned since the 1976 swine-flu concern in terms of decision-making, as well as the safety monitoring, as well as understanding production, so I think there's a lot that's happened,'' said Dr. Anne Suchat, head of the CDC's center for immunization and respiratory diseases.
"There are a lot of things being discussed and a lot of expert groups providing input."
Lee Bowman can be reached at bowmanl@shns.com.
Suggestions and comments appreciated.
http://www.nashuatelegraph.com/apps/pbcs.dll/article?AID=/20090503/HEALTH/305039982/-1/style
Health
Published: Sunday, May 3, 2009
Anti-flu action plan Swine-flu outbreak prompts search for faster vaccine production
By LEE BOWMAN Scripps Howard News Service
The widening outbreak of a new strain of swine flu puts a renewed spotlight on technologies aimed at making influenza vaccines much faster than traditional methods.
One of the first things national and international authorities did as they determined they were dealing with a novel virus with genetic ties to flu strains found in people, North American birds, and American and Eurasian pigs was to start working on culturing the virus.
"Anytime we get a new strain, we look to create a seed stock that would be used if we decide to make a vaccine,'' said Dr. Richard Besser, acting director of the federal Centers for Disease Control and Prevention in Atlanta.
It's a standard precaution whenever a nasty new virus crops up, but also reflects the realities of vaccine production. If everything goes right, it still takes six months to get to full-scale production of a new vaccine using the standard technology of growing the virus in eggs.
It takes some 900 million eggs to make 300 million doses of the annual flu shot, or for that much vaccine against a new strain. It's a slow and sometimes difficult process, with the potential for contamination or for egg shortages to interfere. And it isn't yet known how well the new virus grows inside eggs.
There are several alternatives to egg-based vaccines in the works. Most advanced is cell-based vaccine production, which uses lab-grown cell lines, often from kidneys, that are used to host a growing virus.
The virus is injected into the cell, where it multiplies. Then the cell's outer wall is removed and the virus harvested, purified and inactivated before being put into serum.
This process is already used to produce polio vaccine and some flu vaccine in Europe. The U.S. government has contracts with Sanofi-Pasteur and Novartis subsidizing new or refurbished plants using cell technology in Pennsylvania and North Carolina, part of a master plan to increase pandemic "surge" capacity to 600 million doses of vaccine within six months of an outbreak.
And Baxter International, which also uses a cell-based production line, has announced plans to work with the World Health Organization on a swine-flu vaccine.
Another option is a recombinant virus-like particle technology, which works with insect viruses to create a "shell" that mimics the shape of a flu virus and spurs an immune response to it, but lacks the genetic material to replicate or cause infection.
Many researchers and several biotech companies have been working on this approach. Some, including the vaccine firm Novavax, have started human safety trials on their production system and have told CDC officials that they're prepared to start working with the new strain on a contingency basis.
Novavax officials say they could produce significant amounts of new vaccine in as little as 12 weeks.
Besser said last week during a teleconference that no decision has been made about starting work on a new vaccine â or possibly adding the strain to next year's seasonal flu-vaccine formula.
"It's under discussion, but it's not an easy decision,'' he said.
Government health officials are particularly cautious about developing and distributing a vaccine against swine flu because of the institutional memory of botched efforts surrounding the 1976 swine-flu-immunization program.
Officials 33 years ago feared that the virus causing an outbreak in New Jersey was a close cousin of the strain that caused the 1918-19 pandemic that claimed more than 50 million lives worldwide. Genetic testing done more recently now shows the 1976 virus likely came from birds.
But in February 1976, many health officials were convinced the country needed vaccine protection before the next flu season and started a massive project to make enough doses for everyone.
The mass inoculation reached only about 40 million Americans before the effort was cut short because hundreds suffered Guillain-Barre syndrome â a condition in which the immune system attacks the nervous system â after getting the shots.
And the swine-flu threat fizzled, with only about 200 reported cases in all.
"There's a lot that's been learned since the 1976 swine-flu concern in terms of decision-making, as well as the safety monitoring, as well as understanding production, so I think there's a lot that's happened,'' said Dr. Anne Suchat, head of the CDC's center for immunization and respiratory diseases.
"There are a lot of things being discussed and a lot of expert groups providing input."
Lee Bowman can be reached at bowmanl@shns.com.