Bird Flu Vaccine in Development BEFORE Virus Mutated

January 29, 2004

Hello Steve:

(Vaccine Researchers Read Tea Leaves or Remote View the need for (human) bird flu vaccine, almost a year before the mutated virus breaks out in Asia.)

This gets even better. The WHO released an article that stated they hoped to have a prototype of Avian Influenza vaccine ready in (now get this) ONE WEEK. It is estimated to be ready for public marketing in months.

Now, here is where it gets even better:

I had to rub my eyes and read again. Yep, they stated ONE WEEK to prototype vaccine against H5N1 avian influenza.

We have been hearing that the avian influenza virus has just mutated this season and has taken a giant leap foward in mutation prompting researchers to worry about a pandemic that would mutate again thus spreading person to person. Normally, bird flu spreads from bird to human via droplet transmission.

So, are the news articles simply paranoia. I thought so. Till now. Bird flu in 2003 only killed ONE person in Hong Kong and two in China. Even now that cases are low, too low for the paranoia being perpertrated on our TV sets each evening during the network news shows.

Well, I read the WHO article about their reverse genetic vaccine and wondered, ONE WEEK to prototype? I know it can take 7 -10 years to get a vaccine to market. Months?

Well, I dug a little deeper and guess what I found? You got it, April 9, 2003 a reverse genetic vaccine for H5N1 was in the works. This is BEFORE we even heard about a mutated bird flu. What gives?

Well, in reading, the article stated that the vaccine had to be developed using P4 also known as BSL 4 containment because if not employed, it would KILL the research staff. I wonder how they knew this would occur? Probably lost a researcher or two to this bird flu due to vaccine manipulation of the virus. My guess is that they probably took bird flu, and took some material from human flu, combined it to enable the human body to develop antibodies.

Again, it gets better. They developed this style of reverse genetics not for avian influenza, but for SARS. This was part of SARS research specifically an attempt to develop a SARS vaccine.

Normally, working with influenza virus is done at BSL 2. Even the Pasteur Influenza lab uses BSL 2. This is the first time I have heard of using BSL 4 or known as P 4 for flu.

In any event, Steve, here are the articles. The first dated Jan. 29, 2004 re H5N1 vaccine via reverse genetics. It also describes the process. I think that part of the process is recombination with (probably) fujian flu. The second article, is the obscure website at biomedcentral that discusses the April 9, 2003 development of bird flu vaccine via reverse genetic manipulation.

This is amazing. So, we see that bird flu was manipulated BEFORE it took its giant leap foward in evolution to mutate more virulent. Think it had help mutating from this experiment? BTW, I did not know that St. Jude's Children's Research had a BSL 4 lab in Tennesse? If they are researching this vaccine there, they must be at P 4.

So, it appears that they knew bird flu did mutate and anticipate it to mutate even more. Dr. Frankenstein does know his monster and recognizes that the monster is dangerous.

Again, it looks like we were lied to.

Patricia Doyle

Jan. 29, 2004 Three WHO collaborating centers-The US Centers for Disease Control and Prevention, St Jude's Children's Research Hospital in Memphis, and the UK's NIBSC-are now using the technology to create a prototype H5N1 vaccine virus. The focus of attention in vaccine strain production is the hemagglutinin gene, said Stohr.

Wood says work with the virus sample from Vietnam is being done under strict P4 conditions, "or it would kill the staff." His team will remove a stretch of 4 or 5 basic amino acids at the hemagglutinin cleavage site that allows the virus to replicate in every organ of a chicken's body, rather than respiratory and gut tissue normally infected. "We are making a jump to guess this is also important in humans," he said. The NIBSC team extracted the viral RNA last week, said Wood, and is now growing the appropriate plasmids in the laboratory. Using other lab strain flu plasmids containing the other components of the viral genome, the team will then reassort the pieces into a nonpathogenic vaccine strain. "We hope to 'rescue' the reassortment virus next week," said Wood. After that comes amplification in embryonated hen's eggs, followed by safety testing in chickens and in ferrets. Sufficient amounts of safety-tested prototype vaccine virus will probably be available for the necessary 1 to 2 months of clinical trials in the next 4 weeks, Stohr told The Scientist. Large-scale commercial production requires negotiation with MedImmune, the US company that holds the patent for the technique, he added, but the company indicated to the WHO in April last year that it would be willing to do this "and that they would charge very moderate licensing fees, and consider special conditions for developing countries. They';ve told us they would not want any country to be unable to produce an affordable vaccine." WHO would probably help coordinate the trials to assess what the antigen concentration will be, how many doses should be given, what adjuvants may help, or how each human age group will react. "And they could be done in parallel with the production of clinical batches, so production could begin immediately," he said. The next hurdle would be regulatory approval. "As the European Union may consider this to be a genetically modified organism, that would impose much higher safety standards during manufacture, until inactivation," Stohr believes. "But the potential danger of not having a vaccine ready might influence their decision. They will have to look at the losses and benefits." The reason such urgency is being given to the vaccine production is the fact that the eight genes of the H5N1 avian influenza could shuffle with the eight genes of human flu in a coinfected individual, with the potential to create a human pandemic. "But we don';t want to create panic," Stohr told The Scientist. "We have a window of opportunity to keep this in the box," by slaughtering the infected animals, he said. In cells infected with influenza, the viral genome dissociates and the separate genes multiply and recombine to make new virus particles. If both human and avian viruses are present in a cell, all possible recombinations can be made, potentially uniting the pathogenicity of the current H5N1 virus with the infectivity and transmissibility of normal human flu. WHO is unwilling to estimate the global mortality if the H5N1 virus recombines to make a human form. In 1918, there were 20 to 40 million deaths in the infamous flu pandemic, but it is argued that many of those were caused by secondary bacterial infections, which could nowadays be more easily handled with antibiotics. On the other hand, says Mike Ryan, director of WHO's Global Outbreak Alert and Response Network, the argument is contentious. "One of the striking facts about that pandemic is the number of perfectly healthy individuals who died within 2 to 3 days of getting sick," he said. According to the WHO's most recent update, only two countries, Vietnam and Thailand, have reported laboratory-confirmed cases of H5N1 infection in humans. Vietnam has reported eight cases, six of them fatal. Thailand has reported three cases, two of them fatal. Links for this article "Bird flu summit urged to act," BBC News, January 28, 2004. http://news.bbc.co.uk/1/hi/world/asia-pacific/3436143.stm

T.M. Powledge, "Quick custom flu vaccines," The Scientist, April 9, 2003. http://www.biomedcentral.com/news/20030409/01

"Annex D: Influenza vaccine," In Influenza Pandemic Preparedness Plan: The Role of WHO and Guidelines for National and Regional Planning, Geneva, Switzerland: World Health Organization, April 1999. http://www.who.int/emc-documents/influenza/docs/index.htm/sec10 .htm

"Avian influenza A(H5N1) in humans-Update 9," World Health Organization Disease Outbreak News, January 27, 2004. http://www.who.int/csr/don/2004_01_27a/en/

Now for the April 9, 2003 article:

http://www.biomedcentral.com/news/20030409/01

Quick custom flu vaccines Technique used to craft new H5N1 vaccine could speed development for all new strains. | By Tabitha M Powledge


A genetic technique that accelerates development of vaccines against some emerging viruses has resulted in an experimental vaccine designed to fight a new form of avian influenza that killed at least one person in Hong Kong in February. Researchers at St. Jude Children's Research Hospital in Memphis, Tennessee, say their approach, based on reverse genetics, means much speedier creation of influenza vaccines. Other researchers agree, and expect that eventually the method can be applied to additional diseases. SARS, however, is probably not one of them because the genome of its suspected agent, a novel coronavirus, is far too big. The National Institute of Allergy and Infectious Disease announced Friday that it had begun working on a SARS vaccine, but director Anthony Fauci warned the effort would take at least a year or more. "The particular system we used was one developed here at St. Jude, the so-called eight-plasmid reverse genetic system," said Richard Webby, who developed the new flu vaccine with colleague Daniel Perez. "What this allows us to do is custom-make an influenza virus. We can remove bits, we can add bits, and we can swap and change." Influenza vaccine is usually made via classical reassortment between two influenza viruses. That is followed by antibody selection for the particular combination of genes desired. Researchers attempt to zero in on a combination that melds RNA sequences for the two surface glycoproteins from the target strain with six other sequences from a harmless "master" strain. Checking each reassorted virus to identify one with the desired RNA sequences takes a lot of time, however, Webby explained. From the moment a new strain is identified, it can take two-to-three months before the vaccine production process in eggs can even begin. Reverse genetics cuts down on that time dramatically. Researchers clone individual gene sequences of the virus, hand-selecting the sequences for the two target glycoproteins to combine with master strain sequences. "The only thing we will get out at the other end is that particular combination. We don't have to go through a lot of selection of individual viruses," Webby said. The technique also gets around another hurdle. H5N1 is so pathogenic that it kills chicken eggs, making it impossible to grow it to the titers necessary for vaccine development. "What reverse genetics allows you to do is to remove the molecular features that are responsible for that pathogenicity," he added. The reverse genetic technique certainly does speed up the process of developing a vaccine, said Yoshihiro Kawaoka, who holds joint appointments at the University of Wisconsin and the University of Tokyo. In 1999, Kawaoka and his colleagues showed that reverse genetics could be used to build flu viruses one RNA segment at a time (PNAS, 96[16]:9345-9350). "You can make vaccine strains in one week," Kawaoka said. He and his colleagues are attempting to extend the method to other viral diseases. "The use of plasmid-based reverse genetics methods to generate influenza virus vaccine strains not only is a faster methodology, but also allows the insertion of novel safety markers in the vaccine strains, an important consideration when dealing with highly pathogenic influenza viruses, such as the potential pandemic H5N1 virus," said Adolfo Garcia-Sastre, RNA virus researcher at the Mount Sinai School of Medicine. "This facilitates the handling of the vaccine strains before their inactivation to be used as killed vaccines." Links for this article TM Powledge, "Genetic analysis of bird flu," The Scientist, February 27, 2003.

http://www.biomedcentral.com/news/20030227/04/

St. Jude Children's Research Hospital http://www.stjude.org/

R. Walgate, "Latest SARS evidence," The Scientist, April 4, 2003. http://www.biomedcentral.com/news/20030404/03

WHO, "Influenza Pandemic Preparedness Plan, Index A: Influenza Vaccine," April 1999. http://www.who.int/emc-documents/influenza/docs/index.htm/sec10 .htm

Patricia A. Doyle, PhD Please visit my "Emerging Diseases" message board at:

http://www.clickitnews.com/ubbthreads/postlist.php?Cat=&Board=emergingdiseases Zhan le Devlesa tai sastimasa Go with God and in Good Health