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INFLUENZA 2009

GPO delays flu vaccine testing after guinea pig infection

By Pongphon Sarnsamak
The Nation.
Published on September 17, 2009

The Government Pharmaceutical Organisation (GPO) will decide next Wednesday whether to delay the first phase of clinical trials of a vaccine against a new strain of type-A (H1N1) influenza discovered after a test with guinea pigs found one had an infection in its lungs.

Meanwhile, the Public Health Ministry announced yesterday the type-A (H1N1) virus has killed 11 people during the past seven days, bringing total fatalities to 153. Most were suffering underlying diseases.
The GPO had planned to run its first clinical vaccine trial against the flu virus on September 21. However, after finding an infection during an animal trial, GPO decided to put off its human trials for another three days.
GPO board chairperson, Dr Wichai Chokwiwat said the board will meet on Friday to discuss results of the animal trial where one of ten guinea pigs was found to have developed pockmarks in its lung.
"We will have to study all information about the guinea pig tests carefully before we make a decision whether or not to begin testing the vaccine in 24 volunteers from September 24," he said.

"We will postpone the human trials if we find any problems in the first lot of vaccine against new flu virus," he said.
Wichai said he has consulted with experts about the marks in the guinea pig's lungs and been advised they might have been caused by an abnormality in the animal and not by the vaccine.

He said scientists had injected the vaccine into two guinea pigs with the same concentration planned for humans. One of the two guinea pigs developed an infection which might have been caused by a previous lesion.
GPO's deputy director, Somchai Srichainaka said they were negotiating with the Livestock Development Department to produce local specific pathogen free eggs for the production of vaccine.
GPO has faced problems importing these hen's eggs for vaccine development from Germany and the United States.The long distance transportation might be affecting specific eggs and causing the virus incubated in them to grow more slowly. However 3,000 eggs from the US will arrive today.

Somchai said Thailand would save expense in the long term if it could produce local specific free pathogen eggs, reducing costs from Bt180 to Bt120 an egg. GPO has asked the US Food and Drug Administration for help with production of the specific free pathogen.
World Health Organisation (WHO) representative to Thailand, Dr Maureen Birmingham, said WHO is negotiating with two leading vaccine makers,Sanofi Pasteur and GlaxoSmithKline, to contribute vaccine to the WHO for distribution to developing countries. Agreement is expected in the next two weeks.


-- The Nation 2009/09/17

[ronz28]

Four Swine Flu Vaccines Approved by US FDA
Friday, September 18, 2009
The FDA just approved four versions of the pandemic H1N1 (or “swine” flu) vaccine. Expected to become available as early as the first week of October, here is the run down on each of these four vaccines:

Sanofi Pasteur’s injected vaccine: Approved for ALL age groups (infants 6 months of age through adulthood and the elderly). It comes in several forms:
Prefilled single ½ dose syringe with NO mercury – for infants 6 thru 35 months of age.
Prefilled single full dose syringe with NO mercury – for anyone 3 years and older.
Single-dose (full-dose) vial with NO mercury – for anyone 3 years and older.
Multidose bottle (contains ten full doses or twenty ½ doses) WITH 25 mcg of mercury per full dose – for anyone 6 months and older (infants 6 to 35 months would get a half dose (0.25 ml), 3 years and older would get the full 0.5 ml dose).
Other ingredients include: the viral proteins, gelatin, formaldehyde, polyethylene glycol p-isooctyphenyl ether, sucrose.

CSL’s injected vaccine: Approved for anyone 18 years and older. It comes in two forms:

Prefilled single-dose syringe with NO mercury.
Multidose bottle with ten doses WITH 24.5 mcg of mercury per dose.
Other ingredients include: the viral proteins, sodium chloride, sodium phosphate, potassium phosphate, calcium, taurodeoxycholate, egg protein, 2 antibiotics, and beta-propiolactone.


Novartis’s injected vaccine: Approved for anyone 4 years and older. It comes in two forms:

Prefilled single-dose syringes with a trace amount of mercury (less than 1 mcg because 99% of it is filtered out).
Multidose bottle with ten doses WITH 25 mcg of mercury per dose.
Other ingredients include: the viral proteins, sodium chloride, phosphate, egg proteins, two antibiotics, betapropiolactone, nonylphenol ethoxylate.


MedImmune’s live virus nasal spray vaccine: Approved for anyone 2 years through 49 years of age. There is no mercury.

Other ingredients include: the live viruses, MSG, pig gelatin, arginine, sucrose, potassium phosphate, an antibiotic,


How are these vaccines manufactured?

Here is the interesting part. Everyone has been worrying and theorizing about how these BRAND NEW vaccines are going to be made and what new and dangerous ingredients they might contain. Well, what has ended up happening is that these four companies have made their “swine” flu vaccines using the exact same process and ingredients that they’ve used for their regular flu vaccines. All they’ve changed is the strain of the flu germs that go into the vaccine. Not to say that these vaccines are completely chemical free and 100% safe. But we aren’t dealing with brand new flu vaccines here. We are dealing with the same thing we face with flu shots every year: same chemical ingredients, new flu vaccine strains. You can find out more details on how regular flu shots are made in the flu chapter of the vaccine book, and apply that same process to the “swine” flu vaccines.

Sanofi Pasteur’s pandemic H1N1 vaccine is analogous to their regular flu vaccine Fluzone, a brand that has been in use for several years.
CSL’s pandemic H1N1 vaccine is analogous to their regular flu vaccine Afluria, a newer player in the flu vaccine market that was first made last year for the 2008/2009 flu season.
Novartis’s pandemic H1N1 vaccine is analogous to their regular flu vaccine Fluvirin, which has been around for a few years (previously made by Chiron).
MedImmune’s live nasal spray pandemic H1N1 vaccine is analogous to their regular nasal spray Flumist.

Rest of article is here AskDrSears