วันพุธที่ 6 พฤษภาคม พ.ศ. 2552

Scientists Say Swine Flu Vaccine Could Take Months to Produce

By Carolyn Presutti Washington  Published: 01 May 2009


How to produce swine flu's vaccine

The World Health Organization says several laboratories around the world are developing a vaccination against swine influenza A-H1N1. The organization has raised its alert to level five, just below declaring the flu virus outbreak to be a pandemic. The process of vaccine development can take months.

Vaccine trials are being conducted

As the number of cases grows, so do efforts to develop a vaccine for swine influenza A-H1N1.Dr. Wilbur Chen, who conducted vaccine trials for the avian flu at the University of Maryland, is 




Electron micrograph of Swine flu 

among scientists who monitor animal flu viruses that move to humans.We found him at a vaccine research convention in Baltimore, Maryland.
"We, as vaccine researchers, in this field also would like to move the whole technology forward so we could create vaccines really, really quickly," Dr. Chen said.


Trials will take time to develop

But the process of developing a vaccine could take three months, maybe more. Scientists begin by injecting live virus into fertilized chicken eggs, and then they wait.
The U.S. Centers for Disease Control has already isolated a sample of the virus and has grown what's called a seed stock. A seed stock is a strain of the virus that's the first step toward growing a vaccine.

Ed Mocarski

"We have people who are very interested in the flu, as you can imagine," says Ed Mocarski,
chief scientist with Medimmune, a company that produces vaccines."It has to be tested in animal models to make sure it's safe to go ahead into people," he explained. "And make sure it is live attenuated [disabled virus] and not have some capacity to cause disease."


Balancing benefits and risk of side-effects



It is a delicate
balance between speed and t
he risk of side-effects from the vaccine. Scientists are still haunted by the U.S. massive vaccination program against a swine flu outbreak in 1976. Although a pandemic did not develop, about 30 people died of a neurological disorder thought to be link
ed to the vaccine.

Dr. Robert Belshe

"The risk of having some reactions that might just be transient, maybe just a couple days of pain or fever,


I think would be outweighed by the potential lives saved -- if a virus were really moving through a population rapidly," Dr. Chen stated.
The dosage is determined at human clinical trials. Dr. Robert Belshe runs a vaccine development unit at St. Louis University's, School of Medicine. "It will take a number of months to produce the vaccine and do clinical trials with it," Dr. Belshe said. "Can we do it between now and the Fall? I'm sure vaccine manufacturers are busy now, figuring out what their timeline is and how much vaccine they can produce in the next few months."
Mocarski says they are. "All the companies who are prepared in flu manufacturing would be prepared to rise to that need," he said.


Vaccine research is global effort
The World Health Organization says several laboratories worldwide are working on a vaccine.

Experts say swine flu could slowly diminish now, only to re-emerge later this year.
So scientists need to decide if that danger is great enough to include the new virus in the general flu vaccine this fall.

"We typically have our annual influenza vaccine that has 

Dr. Wilbur Chen

three viral components in it," Dr. Chen explained. These are the viruses we think will circulate next year,and they've already been selected."

Scientists say any determination is not foolproof because the flu is fickle.
"Influenza is unpredictable and that's the only thing we can count on," Dr. Belshe said.

For now, the World Health Organization has advised all countries to activate their pandemic preparedness plan.
Source: http://www.voanews.com/english/2009-05-01-voa15.cfm


The Truth About Swine Flu Should You Accept a Flu Vaccine — Just to be Safe?

By Jane Published: April 29,2009 9.41 A.M.
As stated in the New York Times and elsewhere, flu experts have no idea whether the current seasonal flu vaccine would offer any protection whatsoever against this exotic mutant, and it will take months to create a new one.

But let me tell you, getting vaccinated now would not only offer no protection and potentially cause great harm, it would most likely be loaded with toxic mercury which is used as a preservative in most flu vaccines.

I’ve written extensively about the numerous dangers (and ineffectiveness) of flu vaccines, and why I do not recommend them to anyone. So no matter what you hear — even if it comes from your doctor — don’t get a regular flu shot. They rarely work against seasonal flu…and certainly can’t offer protection against a never-before- seen strain.

Currently, the antiviral drugs Tamiflu and Relenza are the only drugs that appear effective against the (human flu) H1N1 virus, and I strongly believe takingTamiflu to protect yourself against this new virus could be a serious mistake — for all the reasons I already mentioned above.

But in addition to the dangerous side effects of Tamiflu, there is also growing evidence of resistance against the drug. In February, the pre-publication and preliminary findings journal called Nature Precedings published a paper on this concern, stating:


The dramatic rise of oseltamivir [Tamiflu] resistance in the H1N1 serotype in the 2007/2008 season and the fixing of H274Y in the 2008/2009 season has raised concerns regarding individuals at risk for seasonal influenza, as well as development of similar resistance in the H5N1 serotype [bird flu].

Previously, oseltamivir resistance produced changes in H1N1 and H3N2 at multiple positions in treated patients. In contrast, the recently reported resistance involved patients who had not recently taken oseltamivir.


It’s one more reason not to bother with this potentially dangerous drug.

And, once a specific swine flu drug is created, you can be sure that it has not had the time to be tested in clinical trials to determine safety and effectiveness, which puts us right back where I started this article — with a potential repeat of the last dangerous swine flu vaccine, which destroyed the lives of hundreds of people.

Topping the whole mess off, of course, is the fact that if the new vaccine turns out to be a killer, the companies responsible are immune from lawsuits – something I’ve also warned about before on numerous occasions.

Unfortunately, those prospects won’t stop the governments of the world from mandating the vaccine – a scenario I hope we can all avoid.

Avoid Hospitals and Vaccines In this particular case, I’d also recommend you stay away from hospitals unless you’re having an emergency, as hospitals are prime breeding grounds for infections of all kinds, and could be one of the likeliest places you could be exposed to this new bug. Vaccines will not be available for six months at the minimum but when available they will be ineffective and can lead to crippling paralysis like Guillain-Barré Syndrome just as it did in the 70s.

Source: http://janeqrepublican.wordpress.com/2009/04/29/the-truth-about-swine-flu/







A Shot in the Dark: Swine Flu's Vaccine Lessons

By David Brown
Washington Post Staff Writer Publish:Monday, May 27, 2002; Page A09

Twenty-six years ago, the United States government got word that a deadly virus nobody had seen for years -- and which experts thought was gone forever -- was possibly circulating again.

There wasn't any proof it was back, just a few worrisome hints. However, the microbe had killed millions of people earlier in the century, so even a small amount of evidence had to be taken seriously. So, at great effort and expense, the government launched a plan to vaccinate the American population against the virus.

It seemed like a good idea at the time. But it turned into one of the biggest public health debacles in memory.

The disease was swine flu, whose appearance in 1976 was believed to be a reincarnation of the infection that killed tens of millions of people in 1918 and 1919. Today, the U.S. government is engaged in similar deliberations about smallpox, a disease officially eradicated in 1980 but whose virus some experts believe may be possessed by terrorists.

Over the next month, a panel of scientific experts convened by the Centers for Disease Control and Prevention (CDC) will debate the value -- and hazards -- of making the smallpox vaccine available in the United States for the first time in 30 years. Universal vaccination is out of the question, but widespread distribution is possible. By the end of June, the experts will recommend a course of action to the Bush administration.

Influenza and smallpox -- and their vaccines -- differ in innumerable ways, making comparisons tricky. Influenza occurs naturally and spreads quickly. Smallpox hasn't existed outside of laboratory freezers since 1978, but might be in terrorist arsenals. The flu vaccine has few serious side effects, while the smallpox vaccine has many.

Nevertheless, the swine flu campaign is the one recent example of a large, government-sponsored emergency immunization program, and as such may offer lessons for today.

Events began with the death, on Feb. 4, 1976, of an Army recruit at Fort Dix, N.J., during an outbreak of respiratory infections following the holidays. Throat washings were taken from 19 ill soldiers, and a majority tested positive for that winter's dominant strain of the influenza virus, which was called A/Victoria. But four samples were different, and New Jersey public health officials sent them to the CDC to be identified.

On Feb. 12, the CDC delivered a chilling report. The four samples -- which included one from the dead soldier -- were swine flu. As the name suggests, swine flu was endemic to pigs. However, the devastating pandemic of the Spanish flu in 1918 and 1919 is believed to have been caused by a strain of swine flu that, through mutation, gained the ability to infect people.

In 1927, a scholar put the Spanish flu's global mortality at 21.5 million. In 1991, a systematic recalculation raised it to 30 million. The latest estimate, published in the current Bulletin of the History of Medicine, sets the minimum mortality at 50 million, with an upper limit of 100 million.

The possibility that the Spanish flu had reemerged was a matter whose importance is hard to overstate -- and wasn't missed by anyone in 1976. Within days of identifying the strain, federal health officials were meeting at the CDC to discuss what to do.

According to various accounts, the idea that a swine flu epidemic was quite unlikely never received a full airing or a fair hearing, although numerous experts apparently held that view. Instead, the notion that an epidemic was likely enough to warrant population-wide vaccination grew from dominant opinion to unquestioned gospel.

At the same time, the rhetoric of risk suffered steady inflation as the topic moved from the mouths of scientists to the mouths of government officials. In a memo prepared for his superiors at the Department of Health, Education and Welfare (HEW), David Sencer, head of the CDC, talked about the "strong possibility" of a swine flu epidemic. Later, HEW's general counsel commented that "the chances seem to be 1 in 2." A memo from the HEW secretary to the head of the Office of Management and Budget noted that "the projections are that this virus will kill one million Americans in 1976."

A few experts suggested the vaccine be made and stockpiled but used only if there was more evidence of an epidemic. This was considered but rejected early on. The argument was that the influenza vaccine had few, if any, serious side effects, and that it would be far easier (and more defensible) to get it into people's bodies before people started dying.

On March 24, President Gerald Ford announced on television that he was asking Congress for $135 million "to inoculate every man, woman and child in the United States" against swine flu.

Over the next nine months, very little went right -- or as planned.

Pharmaceutical companies undertook crash programs to make enough of the vaccine by the start of flu season in October. But it turned out the Fort Dix bug grew poorly in chicken eggs, the growth medium for the influenza virus. This meant that yields were going to be about half of what was planned. In addition, one company used the wrong virus and had to start over.

The insurance industry announced it wouldn't insure manufacturers against liability arising from the vaccine. An act of Congress shifted most of the liability to the government.

Studies of Fort Dix's soldiers showed that about 500 had been infected with swine flu. But with only one death, this called into question the deadliness of the strain. In addition, swine flu didn't appear that summer in the Southern Hemisphere, as would be expected if a pandemic were starting.

Tests showed that single injections of some vaccine formulations didn't protect children. This required time-consuming studies of a two-shot regimen.

Albert Sabin, the father of the oral polio vaccine and a high-profile advocate, broke with the party line and called for stockpiling, but not immediate use, of the vaccine.

Three elderly people in Pittsburgh died on the same day within hours of getting swine flu shots. It was a chance event, but just the sort of guilt by association that arises whenever a public health intervention is done on a mass scale.

What killed the program, though, was the observation in early December that people given the swine flu vaccine had an increased risk of developing Guillain-Barre syndrome, a rare, usually reversible but occasionally fatal form of paralysis. Research showed that while the actual risk for Guillain-Barre was only about 1 in 1,000 among people who had received the vaccine, that was about seven times higher than for people who didn't get the shot.

On Dec. 16, the swine flu vaccine campaign was halted. About 45 million people had been immunized. The federal government eventually paid out $90 million in damages to people who developed Guillain-Barre. The total bill for the program was more than $400 million.

There are a lot of lessons to draw, said Harvey Fineberg, a former dean of Harvard's School of Public Health, who co-authored an analysis of the "swine flu affair" for Joseph A. Califano, HEW secretary under President Jimmy Carter, who succeeded Ford in January 1977.

Among them: Don't over-promise; think carefully about what needs to be decided when; don't expect the consensus of experts to hold in the face of changing events. The biggest, he said recently, was perhaps the most obvious: Expect the unexpected at all times.

Source: http://www.washingtonpost.com/ac2/wp-dyn/A14517-2002May26






My Reaction


1.WHO told that around the world ‘s laboratory all develop a vaccine against swine flu but the process of developing a vaccine will take a number of months.

2.Beginning method to create a vaccine by injecting virus into fertilized chicken’s egg and then wait for the time.

3.Ed Mocarski (chief scientist of company that produces vaccines.) told that the vaccine has to be tested in animal to make sure it not cause any danger and be able to kill virus.

4.WHO advise all country to activate their preparation plan for an epidemic

.5.As seen in the New York Times and other media, flu expert are not sure whether this vaccine can provide any protection against swine flu

6.The writer is not recommend anyone to get this flu vaccine due to it’s ineffective and can cause many of harm

7.Presently, the drugs that appear effective against the H1N1 virus are the antiviral drugs Tamiflu and Relenza

8.There’s growing evidence of hazardous side effect of Tamiflu.

9.Avoid going to hospital and vaccine, hospital could be more expose to the public about this new bug.

10.Swine flu appeared in 1976 once and according to studies of Fort Dix's soldiers showed that 500 people had been infected but only one people death. Whereas there were three elderly people in Pittburgh died within hours after getting swine flu shot.

11.The observation in the 70s , it revealed that people who getting this swine flu vaccine have increased more risk to be crippling paralysis like Guillain-Barré Syndrome.

Conclusion

Currently, Swine flu has been spreaded into many country, from North America to Asia. And the government in each country that has some infected or suspected people are working so hard to solve this influenza.
Right now there is a swine flu’s vaccine which is currently in process but it could take months to manufacture and distribute widely. But no one confirm the effective of this vaccine against swine flu. However the side effect can be severe like in the 70s the vaccine caused Guillain-Barré Syndrome that led many died . I hope last lesson would be a good teaching for the epidemic this time. And before everyone get vaccine should make sure that the scientists test the vaccine really well and should wait for the official to confirm that the vaccine has an ability to prevent this virus and could not make any danger or side effect.


For now, you should have a basic protection for your own safety by cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it and wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective. Avoid touching your eyes, nose or mouth. Germs spread this way. At last, try to avoid close contact with sick people.

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