Sometimes I (and I'm sure someone else) need a place to post vaccine development. Sometimes news are only press release, so must be taken as-is, but I think they are anyway usefull.

Instead of using the World development thread (as I did this morning) I think it's time to create a thread for news about vaccine development.

Only press-release, sorry:

http://www.prnewswire.com/cgi-bin/s...+2006,+07:45+AM

Seems good thinking to me ...

Thanks for the post, and for confirming what I've learned in the past--people allergic to eggs should NOT take Flumist.

And even though it's a press release, the information is really interesting.

If we don't make this a sticky it'll be pushed off the board in no time.

Deal struck to conduct vaccine tests on people - children in particular

Bangkok Post - Friday July 07, 2006
APINYA WIPATAYOTIN PIYAPORN WONGRUANG

The Public Health Ministry and the world's third-largest pharmaceutical firm, sanofi pasteur, have reached an initial agreement to jointly conduct trials of an avian flu vaccine on humans early next year. The vaccine trial would be conducted on children aged six months to 18 years because the young were more vulnerable to a flu pandemic than adults, said Tawee Chotpitayasunondh, a member of the ministry's human avian flu study panel.

The ministry had been negotiating with the firm after the deal on a vaccine trial against the H5N1 strain of bird flu virus with Japan was aborted last month.

Speaking at a press conference on the sidelines of the meeting on Influenza Pandemic Preparedness held in Pattaya, Dr Tawee said further study must be done on developing an H5N1 vaccine for humans as the avian flu virus had various forms and a vaccine formula that was effective in Vietnam and Thailand might not be in China and Indonesia.

Sunate Chuenkitmongkol, medical director of sanofi pasteur, said the company hoped it would be able to launch H5N1 vaccine trials on humans early next year.

The vaccine trials on children would take around six months to a year, she said, adding that the project was pending approval from the national committee on human vaccine trial ethics. The Public Health Ministry and the firm was also negotiating a benefit-sharing agreement.

If approved, Thailand would be the first country in Southeast Asia to conduct H5N1 vaccine trials on children.

''The vaccine trials aim to find proper doses of the vaccine to help the body to generate immunity against the disease. The trials will also let us know proper timing for vaccinations,'' she said.

Meanwhile, caretaker Prime Minister Thaksin Shinawatra yesterday instructed health and livestock officials not to lower their guard against bird flu.

Speaking at a meeting on Bird Flu Preparedness at Government House, Mr Thaksin said he did not want to see bird flu return now the country had successfully controlled it and had earned recognition from the international community.

The country had been free of bird flu outbreak for 239 days, as of yesterday.

Caretaker Agriculture and Cooperatives Minister Sudarat Keyuraphan said the ministry had instructed its officials to conduct nationwide bird flu surveillance 'X-rays' more frequently.

Yukol Limlamthong, Livestock Development Department chief, said manuals on bird flu prevention had been distributed to people, but they had failed to follow the instructions.

He was referring to a recent report that villagers from Sam Ngam district in the northern province of Phichit ate dead chickens, which died of unknown causes.

Twenty villagers were being monitored for signs of illness on Tuesday.

Yesterday evening I was watching one of the most important Italian television: there was a scientific program (the most important and most watched scientific program in Italy, called "SuperQuark"). They spoke with an expert of Milan's Sacco Hospital (front-line in Italian defenses against infectous deseases) about avian flu, and vaccine in particular. This expert seemed warried, but not too warried. About vaccine she said some things that made me thinking about. I'd like to share these with you.

1) She said it will take 3 to 6 months for having vaccine for 10% population (in Italy we are 56 million, so 10% is 5,6 million doses, and, AFAIK we have only 2 manufacturer in our soil). This to me seems a lot optimistic! Too optimistic perhaps...
2) a question was about who will be the fist vaccinated. She answered: before all people involved in vaccine production and transportation, people who are needed for essential services (water, electricity, police, health care workers and so on). After these, the next category will be all people in work age: from 20 to 50 years old.

In particular, the point 2 above to me seems very very interesting!

Another news. But they don't speak about timing...

http://www.pharmaceutical-business-...7B-280916C34E5F

This is a day full of news about vaccine!

http://www.bangkokpost.com/News/07Jul2006_news08.php

Oh yes, especially if you count dups - this is post #5, that's 3 posts up.

Now here's the problem with vaccination, according to Revere.

Is vaccinating poultry for bird flu obscuring cases?

Category: Bird flu • Vaccines
Posted on: July 6, 2006 7:30 AM, by revere

Several countries have elected to vaccinate poultry as a bird flu control measure. Vietnam and China both have such programs. The Vietnamese program is credited with their good record on bird flu this year. But poultry vaccination has some down sides:There are two distinct problems for surveillance. You lose the warning signal from poultry infections so you are not as vigilant for human infection and your diagnostic index of suspicion may be low, causing missed cases. And vaccination can mask infection in birds. Even if the vaccine works, the birds may still be infected and shed virus (although at much lower levels), but appear healthy. If the vaccinators are poorly trained or the vaccine is adulterated the vaccination may be ineffective, and the workers may even spread the virus by trekking it from farm to farm. There is suspicion this has happened in China and the Indonesian program is said to be poorly run and managed. With billions of birds requiring continuing vaccination each year the task is daunting and difficult to carry out successfully, even with adequate resources and political will.

No bird flu cases have been reported in Vietnam for six months. But this doesn't mean no one is getting sick from illnesses that might be avian influenza. There is currently a huge outbreak of dengue fever, a mosquito-borne illness whose diagnosis can easily be confused with influenza. A listing of dengue's clinical features shows why:Nearly 20,000 cases of dengue have been reported in the south of Vietnam in the first six months of this year, 54% more than the first six months last year (Xinhua). The outbreak is being blamed on poor household control of mosquito breeding sites.

One wonders.

Ops... sorry Christian. You're right, my mistake

They are testing a vax on humans in Australia too - Perth, Adelaide and Melbourne. A friend of mine is considering doing the trial (I've seen the email she received about it).

They are using aluminium in the vax and varying doses of the virus. It's the Vietnam strain also, so very very similar to the articles already mentioned.

If I can get a copy of her email I'll post it.

Please do But, leave out any personal names and addy's. Thanks

__________________
Being happy doesn't mean everything is perfect.
It means you decide to see beyond the imperfections.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Live each day as if there is World enough and Time~
Arubi 

I got a copy of the document that my friend was sent - would be very interested to hear any opinions you all have about it.

I've put it here (it's about 650k in size) - please download a copy if you're interested as I won't keep it online for too long.

CSL vax document

Thanks a lot!!! I downloaded the doc file and I'll read soon.

Another thread by a DNA vaccine:

http://www.curevents.com/vb/showthread.php?t=53082

Thanks SoccerMom.

Previous article didn't mention company's name: PowderMed

Link here:
http://www.nasdaq.com/aspxcontent/N...nternational.na

Lets hope for some good results.

It's not a vaccine, but a drug news, but in the meantime I bump this thread

http://www.news.com.au/story/0,1011...1-29277,00.html

Anoter drug, even if I don't know anything about nano-technology drugs. Side effects? mmmm

http://nanotechwire.com/news.asp?nid=3517

http://www.focus-fen.net/index.php?...atte=2006-07-23

But he is speaking about human vaccine??? So they are planning to administer vaccine in regions where B2B H5N1 will be present? I'm missing something probably

Nothing really new in this article, but the last sentence make me thinking...

http://www.lsj.com/apps/pbcs.dll/ar...50326/1082/life

http://www.rte.ie/business/2006/0726/glaxo.html

On GSK site there are more info about latest news:

http://www.gsk.com/ControllerServle...=402&newsid=868

Bumped. I'd like to know some opinions about latest gsk news (that it's all over the newsnow site right now). IMO it's a very big step ahead: yes, the virus strain is not perfect, but at least it may offer some kind of protection, and can be stockpiled from the end of 2006

This sounds very exciting! Maybe, if H5N1 holds off another few years and this vax proceeds successfully, there might actually be an adequate supply of vaccine to keep it from ever gaining a real foothold.

Wouldn't it be great if we could really scratch H5N1 off our list of concerns at some point?

Kris (MomCares)

__________________

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Yes I agree. And I think this is only the first good news of a series in this area. A lot of companies are working with this, not only GSK. Let's hope H5N1 will not strike in 2006

http://www.insidebayarea.com/trival...news/ci_4101290

Since vaccine doesn't require a prescription (at least I don't think so), if this vaccine is at some point available in some countries I wonder if it would be possible for individuals to buy doses even if their government doesn't?

Kris (MomCares)

__________________

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

I don't know in other countries, but in Italy anyone can buy vaccine, if it's available of course. And of course it's possibile also to buy online from another country (but we must be sure for the source...)

Surfing the net for some news I found this quite old article (21 April 2006) of the journal Science. It's a good summary of current development about vaccines IMO. A good reading.

I cannot quote here: there are 2 images which are very usefull IMO (above all the second one).
For who wants to read:
http://sciencemag.org/cgi/content/full/312/5772/380
"A One-Size-Fits-All Flu Vaccine?"

Science 21 April 2006:
Vol. 312. no. 5772, pp. 380 - 382
DOI: 10.1126/science.312.5772.380

Prev | Table of Contents | Next
News
A One-Size-Fits-All Flu Vaccine?
Jocelyn Kaiser

The threat of avian influenza has revived efforts to develop "universal" flu vaccines that protect against all human influenza strains. Although that goal remains elusive, vaccines that protect against seasonal flu variants could be closer
Modern medicine's main weapon against the influenza virus is woefully unsophisticated. Each year, companies have to make a new batch of flu vaccine because unlike, say, polio or chickenpox, flu strains change every year. The vaccine is grown in eggs, a process that takes up to 9 months, and people have to be vaccinated annually, which many don't bother to do. More troubling, if a pandemic strain of influenza came along, the virus could kill millions of people in the time it would take to prepare a matching vaccine.

What scientists dream of is a vaccine that can protect against any flu strain for years or even a lifetime. This so-called universal flu vaccine is still a long way off, if it's even possible. But many labs are dusting off past projects on broad flu vaccines, spurred by new funding and fears that H5N1, the deadly avian influenza that has swept across half the world, could acquire the ability to be transmitted from human to human. Until now, "flu has never been before high enough on the radar screen" for companies in particular to follow through with a strong push for a universal vaccine, says Gary Nabel, director of the Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland.

Doing so, however, means coming up with an alternative way to stimulate immunity to the virus. The tried-and-true technique for seasonal flu uses a killed virus vaccine that works mainly by triggering antibodies to hemagglutinin (HA), the glycoprotein on the virus's surface that it uses to bind to human cells. Hemagglutinin and neuraminidase (NA), another surface glycoprotein that helps newly made viruses exit cells, give strains their names (H5N1, for example). The sequences of HA and NA mutate easily, which is why each season's flu strain--although it may be the same in subtype, such as H3N2--"drifts" slightly from the previous year's, and the annual vaccine must be tailor-made.

To make a universal vaccine for influenza A, which includes the main seasonal flu strains and bird flu, as well as past pandemic strains, some scientists are hoping to use "conserved" flu proteins that don't mutate much year to year. (Influenza B, the other type, occurs only in humans and causes milder symptoms.) Some of the conserved protein vaccines in the works stimulate production of antibodies as do conventional flu vaccines, whereas others rouse certain immune system cells to battle the virus.


Weak spots. A universal flu vaccine would target "conserved" proteins, such as M2 or NP, an inner protein.

CREDIT: C. BICKEL/SCIENCE

Other scientists are pursuing a slightly less ambitious goal: They are working on vaccines that match a particular HA, such as the H5 in H5N1, but that also protect against "drift" strains that typically emerge from year to year.

It's not yet clear whether any of these broad vaccines will ever work as well as a traditional, HA-matched vaccine. But they could help when the annual vaccine doesn't match the circulating strain exactly, and in a pandemic, they could reduce deaths until a matched vaccine is ready. "Anything that would dampen a pandemic would be useful," says virologist Robert Couch of Baylor College of Medicine in Houston, Texas.

One for all
One of the most hotly pursued strategies for a universal vaccine against influenza A is based on a flu protein called M2. This protein forms an ion channel crossing the membrane of a virus particle or infected cell, barely jutting out from the surface. It's an appealing target because the 23 amino acids that make up the ectodomain, or protruding part, of M2 (known as M2e) scarcely vary from one human flu strain to the next, even back to the 1918 Spanish flu.

Scientists first showed in the late 1980s that antibodies to M2 can slow flu infection in mice. In 1999, biochemist Walter Fiers's team at Ghent University in Belgium reported in Nature Medicine that it had reduced flu deaths in mice with a vaccine made of M2e fused to another protein, the core of the hepatitis B virus (HepB). (These proteins clumped into viruslike particles bristling with M2e that stimulated more antibodies to M2e than did the protein by itself.) In its latest paper in Vaccine in January, Fiers's lab, now collaborating with the vaccine company Acambis in Cambridge, Massachusetts, has improved the candidate vaccine by attaching three copies of M2e to the HepB core, delivering it nasally--which boosts immune responses compared to injection--and adding an adjuvant, an ingredient that also increases the body's immune response.

Although M2e is typically conserved, there's a small chance that the protein could still evolve, enabling the virus to evade a vaccine. To assess that risk, Walter Gerhard's group at the Wistar Institute in Philadelphia, Pennsylvania, pushed the virus to mutate by exposing mice with weak immune systems to an H1N1 seasonal flu strain while giving them antibodies specific to M2e. As they reported last June in the Journal of Virology, M2e mutants appeared in some mice after 3 weeks, but there were only two types--fewer than might have been expected. "To us, that was reassuring," Gerhard says, because it should be possible to make an M2e vaccine to match the few anticipated variants.

Another major caveat is that although M2 vaccines may prevent deaths from flu, they may not keep people from getting sick, the way conventional vaccines normally do, notes Couch. That's because M2 antibodies seem to work by binding to infected cells and promoting their clearance, instead of blocking the virus (which sports few M2 surface proteins) from infecting new cells, as traditional vaccines are thought to do. Fiers's mice, for instance, still get sick and lose some weight, although they do survive. Fiers argues that, given the limitations of current seasonal flu vaccines--a regular flu vaccine matches the circulating strain only 80% to 90% of the time and often doesn't work at all in the elderly, whose immune systems aren't good at making new antibodies--M2 vaccines are a possible replacement. Others, including Gerhard, see M2 vaccines as a backup to regular vaccines, perhaps as an added component in annual flu shots.

Some experts caution that it's too early to say that M2 vaccines will work in people, as opposed to mice. Retired New York Medical College virologist Edwin Kilbourne, for instance, questions whether Fiers challenged mice with sufficiently high doses of virus.

Despite the skepticism, several companies hope to commercialize M2 flu vaccines, including Switzerland-based Cytos Biotechnology; Acambis expects to submit a clinical trial application to the U.S. Food and Drug Administration (FDA) this year. Acambis's Ashley Birkett agrees that "we need to see how it performs in the clinic." Another contender is Merck, which has done animal tests on an M2 vaccine combined with an influenza B vaccine made from a conserved stretch of the virus's HA, says Merck researcher Antonello Pessi.

Looking inside
Another approach to a universal flu vaccine uses conserved internal proteins such as nucleoprotein (NP) to elicit a different kind of immunity, one based on a type of T cell called a cytotoxic T lymphocyte (CTL) rather than on antibodies. CTLs recognize and kill infected cells expressing viral antigens, fragments of proteins such as NP.


CREDIT: WALTER FIERS (PHOTO)

Researchers at Merck and Vical Inc., a biotech company in San Diego, California, reported 13 years ago that a vaccine based on NP partially protected mice from seasonal influenza A, although some animals still died. Instead of immunizing the animals with NP itself, the researchers used DNA encoding the protein as the vaccine, a strategy that often generates a more powerful cellular immune response. Last year, FDA researcher Suzanne Epstein and others showed that mice survived seasonal flu and could be partially protected against dying from H5N1 by an NP-based DNA vaccine boosted by ferrying the DNA into cells inside an adenovirus disabled so it can't replicate.

Like M2 vaccines, vaccines based on internal viral proteins won't prevent infection altogether because CTLs target already infected cells. Still, says Epstein, they could offer some protection until a pandemic vaccine is produced. Her group is now looking at a DNA vaccine that combines NP and M2, a strategy also being pursued by Vical with NIAID support. Others are considering the inner proteins not for a stand-alone vaccine but as adjuvants that could broaden the immune response to HA-based vaccines.

One overarching question is whether long-lasting immune protection against different flu subtypes--whether through CTLs, M2, or some other mechanism--is possible in humans. The epidemiological data have been scanty. But Epstein recently found suggestive evidence by analyzing old records from a study of 60 Cleveland, Ohio, families who experienced the 1957 H2N2 flu pandemic. Epstein reports in the January 2006 Journal of Infectious Diseases that adults (but not children) who had lab-verified H1N1 flu in the years before that pandemic were one-third as likely to get sick with the 1957 H2N2 flu.

Narrowing in
With the two main approaches to making a truly universal flu vaccine still a question mark, some investigators are working on a seemingly more approachable goal: making HA-specific vaccines that protect against drift strains within the same HA family.

One way to achieve this broad immunity is with a live attenuated vaccine, which consists of a virus that can still infect cells and thus should induce CTL responses. A live attenuated nasal vaccine made each year for annual flu, FluMist, has been on the market since 2003 in the United States. Manufacturer MedImmune says that it protects against mismatched strains. MedImmune and NIAID will soon begin clinical testing of FluMist versions for potential pandemic strains such as H5N1 and H9N2. The downside of live vaccines, however, is that there is a small risk that the virus could revert to a dangerous form, perhaps even creating a new pandemic strain.

A safer way to achieve protection against drift pandemic strains may be with DNA encoding the HA surface protein delivered by means of a viral vector. Compared to the traditional killed virus vaccine, this should stimulate broadly protective CTL responses to conserved parts of the HA protein that are shared by related strains. Separate teams at the University of Pittsburgh in Pennsylvania and Purdue University in West Lafayette, Indiana, both collaborating with the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, reported in The Lancet and the Journal of Virology in February that an adenovirus-delivered vaccine based on H5 DNA protected against both the 1997 Hong Kong strain of H5N1 and the 2004 Vietnam strain. One advantage compared to conventional egg-grown vaccines: The manufacturing of the vaccine is done with cells, and "you can make millions of doses in a month's time," says Suryaprakash Sambhara of CDC, senior author on the Lancet study.

Both universities are seeking funding for clinical tests from NIAID and companies. Sambhara plans to give the Purdue team an adenovirus-based vaccine containing genes for NP and M, which codes for M2 and an inner protein, as well as H5HA; and Andrea Gambotto of Pittsburgh hopes his vaccine, which also worked in chickens, may be picked up as a bird vaccine. A company called PowderMed avoids using adenoviruses to deliver the DNA, which have some drawbacks, instead using gold-coated particles and high-speed injection to get HA-based DNA vaccines into a person's skin cells.

Although the variety of approaches to broader flu vaccines can be dizzying, "having all of those efforts moving forward gives us more weapons in the arsenal and makes us more likely to find the best platform," NIAID's Nabel says. Even if one approach rises to the top, there are many obstacles ahead, such as persuading regulatory agencies--who now approve flu vaccines based only on HA antibody responses--to use CTL responses as a measure of efficacy instead, notes virologist Albert Osterhaus of Erasmus University in Rotterdam, the Netherlands. Still, if universal--or at least broader--flu vaccines can make it to the market, they could save lives during regular flu season and stave off disaster when the next pandemic strikes.

The editors suggest the following related resources on Science sites:
In Science Magazine

Introduction to special issue:
Influenza: The State of Our Ignorance
Caroline Ash and Leslie Roberts
Science 21 April 2006: 379 | Summary » | PDF »

__________________
 

Poor poor monkeys....

http://www.terra.net.lb/wp/Articles...84&ChannelId=19

Again: it's a long long run yet... (and it's a PR, so we must be carefull)

http://www.prnewswire.com/cgi-bin/s...+2006,+09:38+AM

http://www.diamondbackonline.com/vn...0/44dadd7f9aaa7

It's not a news, but IMO very interesting about timing...

http://www.proteinsciences.com/vaccines.htm

I have a couple of updates to add to this Vaccine Thread also:

AND

The best prototype Pandemic vaccine in the world is of little use to a country if there is no abilitity (or limited ability) to make it for the people.

It looks like Canada will be in an excellent position when it comes time to hand out Pandemic vaccine. Actually, Marco, if Italy has two vaccine producing facilities, Italy should also be in good shape to make Pandemic vaccine fast for their general public. Countries with larger populations (and 3rd World Countries), will have to build facilities, or more facilities, to catch up. That will take years. Time we may not have.

I see that Canada is planning to secure enough Pandemic vaccine for 25 to 30 million double doses. That is enough vaccine to vaccinate every man, woman, and baby, assuming all could be vaccinated.

One third, to half that much would be enough to break transmission chains and stop a Pandemic (Canada currently orders about 11 million annual flu vaccinations).

In a high fatality Pandemic, vaccine means life or death. It is definitely starting to look like there will be have and have-not nations.

For example, while Canada is apparently trying to vaccinate every single person, only two million doses of vaccine would protect half the population of Finland, and potentially save a whole culture.

P.S. It occurs to me that if Canada is able to vaccinate the whole populace within two months of the start of a Pandemic, they will become a "Pandemic Free Zone". Might be a good place to visit when things get sticky in the rest of the world....

Posting this here for safekeeping:

justathought, I think Canada is very wise, years ahead. In Italy we have (AFAIK) 2 vaccine plants, but they are both from Chiron. Chiron is now part of Novartis, so I really don't know what will be next...

Years away, but worth efforts IMO:

http://www.bionity.com/news/e/57285