Would you get the vaccine?

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Would you get the vaccine if/when they develop one?

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UK: Government Places Order For H1N1 Vaccine

http://afludiary.blogspot.com/2009/05/uk-government-places-order-for-h1n1.html

Another country decides not to wait. Now why do you suppose that they are going to make this very expensive move for a virus that is so mild?

Just 24 hours after the Scottish government announced similar intentions, the UK government today has announced that they have signed deals with two major vaccine manufacturers to provide 90 million `swine flu' shots.

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Sanofi, Glaxo Must Get Ready for Swine Shot, WHO Says

http://www.bloomberg.com/apps/news?pid=20601102&sid=aTZfnknCRnJg&refer=uk

The World Health Organization urged Sanofi-Aventis SA, GlaxoSmithKline Plc and other drugmakers to start preparations for a swine flu vaccine and be ready to mass- produce a shot as early as mid-July.

WHO Director-General Margaret Chan endorsed an expert panel's recommendations that drugmakers should develop batches for testing and get documents ready for regulators to speed the approval process. They shouldn't stop making seasonal flu shots, the agency said today.

"Those are recommendations coming from SAGE to me and I accepted their recommendations," Chan said today at a press conference in Geneva, referring to the Strategic Advisory Group of Experts.

The WHO, armed with limited information about the new flu's virulence, wants pharmaceutical companies to speed production of the vaccine that protects against seasonal influenza, which can kill up to 500,000 people a year, while scientists take a few more weeks to select the fastest-growing strain of the H1N1 virus to form the basis of a protective pandemic vaccine.

Producing Enough Swine Flu Vaccine for Everybody?

Now that sounds very promising but, don't give up on those mitigation strategies yet because frankly there are quite a few problems that may have to be solved before this can happen.

http://afludiary.blogspot.com/2009/05/swine-flu-vaccine-production-delayed.html

The disclosure that making a swine flu vaccine is proving more difficult than experts first thought came as U.N. Secretary-General Ban Ki-moon and WHO chief Dr. Margaret Chan met Tuesday with representatives from up to 30 pharmaceutical companies to discuss the subject.

According to vaccine experts convened by WHO last week, swine flu virus is not growing very fast in laboratories, making it difficult for scientists to get the key ingredient they need for a vaccine, the ''seed stock'' from the virus.

The flu experts said vaccine manufacturers will not be ready to produce a swine flu vaccine until mid-July at the earliest, the agency reported Tuesday on its Web site. Previously, WHO officials had estimated that production could start in late May.

On May 9th, in A Vaccine Reality Check , I rattled off just a few obstacles that I felt could interfere with that timetable.

The virus could mutate over the summer or fall, possibly rendering any vaccine being manufactured now less protective (or even useless).

The virus may not grow well in eggs (that happens sometimes), reducing the amount of antigen that can be produced.

They could discover problems during the animal and human testing phase, which can't even begin until late July.

The much vaunted global manufacturing capacity may not be as high as some have projected.

People may need more than the standard 15 mcg flu shot to provoke an immune response, or need two shots, which would cut down on the number of doses that could be produced.

The logistics of delivering a (prioritized) vaccine to hundreds of millions of people (possibly in two shots a month apart) over a short period of time are tremendous.

And of course, there could be diplomatic wrangling over the sharing of vaccines with developing countries, or over the export of vaccine from the manufacturer's country until their needs have been met.

The virus isn't growing well in the lab. In this case, the seed stock for a candidate vaccine isn't growing well, which could prove problematic for mass production later on as well.

And if you follow the link to read the AP article, the estimates of our being able to produce 5 billion doses of vaccine are - to put it kindly - generous.

...the logistics of producing, and delivering a vaccine are enormous, and should not be underestimated.

WHO: Ad Hoc Report On Swine Flu Vaccine Production

http://www.who.int/csr/resources/publications/swineflu/TC_report_2009_05_14.pdf

Specializes in School LVN, Peds HH.

I won't. Trusting a vaccine thats thrown onto the market that fast is not something I'm prepared to do. Besides, whenever I actually do get the seasonal flu shot I always get sicker than if I don't.

Specializes in Too many to list.

When Will That Flu Vaccine Be Ready?

http://blogs.sciencemag.org/scienceinsider/2009/05/when-will-that.html

Despite recent news report to the contrary, the U.S. Centers for Disease Control and Prevention (CDC) assures ScienceInsider that efforts to make a vaccine against the virus causing the swine flu outbreak have not met unexpected delays.

Confusion about the vaccine timeline stems from a report from the World Health Organization (WHO) yesterday, which recounted a meeting held by a scientific working group that looked closely at the production issues. The advisory working group concluded that manufacturers would not be able to begin "large-scale production" of a vaccine against the novel H1N1 virus until mid-July. The report did not describe these as delays, but many media accounts did, noting that WHO's Marie-Paule Kieny, director of WHO's initiative for vaccine research, earlier predicted that production could begin 2 months earlier and suggested that a vaccine might be ready as early as September.

Tom Skinner, a spokesperson for CDC, assured ScienceInsider that everything is on track. "We're hopeful we can have a vaccine ready by late fall; however, we know that the manufacturing process is complicated, and we need to be prepared in case we run into glitches with production of the vaccine," says Skinner. The timing, of course, depends on the specific steps in the manufacturing process, and CDC and the WHO working group appear to have different estimates on some key points.

The vaccine process begins with the viral isolate being converted into "seed stock." CDC has already sent five isolates to seven laboratories to make this starting material. A key property of seed stock is that it's a weakened, or attenuated, version of the original virus, which makes for a safer production process and lowers the risk of an accidental release.

The WHO report says that manufacturers then typically need 1 to 2 months "to isolate rapid growing strains to maximum yield." Skinner says not so. "They have to do a little more work on it to get it in the condition that they need for the vaccine, and I'm told that takes a couple of weeks, so that by the middle of June toward the end of June, they could start producing pilot lots," he says. These pilot lots are used in small clinical trials to make sure that the vaccine is safe and triggers the appropriate immune responses, a process that Skinner says takes about 8 weeks.

But Skinner stresses that manufacturers do not normally put production of commercial lots of vaccine on hold until they have results from the pilot lot tests. "They're not going to wait until all that's done to start producing the vaccine that the rest of us might need in fall and winter, " says Skinner. "Those two processes are parallel."

As to exactly when this vaccine may be ready, Skinner says that's a question for manufacturers. A spokesperson for GlaxoSmithKline, a major maker of influenza vaccine, says, "We expect the first doses of H1N1 vaccine would be available 4 to 6 months after we receive the seed strain, pending regulatory approval." This means the vaccine would be available in mid-October to mid-December--and that's assuming that no manufacturing problems or unforeseen regulatory issues surface.

Even if the U.S. government decides to purchase vaccine, Skinner acknowledges that the country may not end up using the product if the spread of novel H1N1 doesn't warrant it. "We're going to be looking very carefully at what happens over the summer here in the United States, but particularly at what's happening in the Southern Hemisphere in regard to the new H1N1, to have that information to decide what, if anything, we're going to do in regards to a vaccination campaign later this fall and winter," says Skinner. "But if we think we might need a vaccine, we have to move now to ensure that we have one, and that's what we're doing."

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Candidate virus for H1N1 vaccine arrives at CDC

http://edition.cnn.com/2009/HEALTH/05/22/swine.flu.vaccine/index.html?eref=rss_topstories

The virus used in vaccines is not the actual virus that infects people, but rather a hybrid that's been genetically modified to make it safer, and to give it the ability to multiply more quickly -- a crucial factor when it comes to manufacturing large quantities.

Bucher's method of achieving this has a decidedly old-fashioned feel. She first injects a sample of "wild virus"-- in this case, H1N1 virus she got from the CDC, originally culled from a child who was infected in California this spring -- and then injects a sample of another flu strain that's known for its ability to rapidly multiply in eggs. For that, Bucher is using a strain with the exotic sounding name of NYMC X-157. (That's NYMC as in "New York Medical Center;" it's a hybrid of an H3N2 seasonal virus and the so-called "Puerto Rico strain," A/PR/8/34, that's used to speed the growth of seasonal flu vaccine).

Together in the egg, the viruses swap genes. In a laborious series of steps, Bucher's team guides the changes by adding antibodies that eliminate the surface proteins of the H3N2 virus. The end result is a virus with the exterior proteins of the H1N1 swine flu -- so the immune system recognizes it -- but with the inner mechanics -- the fast-growth ability -- of X-157.

I suppose I would have to get the vaccine if I'm working. I can't imagine being a PCT and being given a skip on getting a vaccine. The first batches will start to be available to the first tier, and that's us, and I'm just not sure that most of us will be given the option. Maybe if I'm working where I have limited exposure to pts? But, for instance, if I was an ER nurse in NYC, would I even have the option? I don't think I would.

This is still months and months out. It might not even be January or February 2010 til we start to see vaccine available. What happens between now and then may give us a lot of time to become used to the idea. If H1N1 hits hard enough, more people might start wanting the vaccine than now.

Specializes in ER and Home Health.

In the military I was vaccinated against everything imaginable. Since getting out, I have consciously chosen against any further immunizations. I have remained healthy despite my choice. Now I do lead a very healthy life style. I drink lots of water. Eat well, Rest well.

I got the vaccine in 76 also. I have had many vaccines in the military and I continue to vaccinate as new ones come out that are appropriate for me. So yes, I would get it.

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H1N1 flu vaccine a step closer as firms test seed

http://www.reuters.com/article/GCA-SwineFlu/idUSTRE5592MH20090610

Drugmakers are on track to have a vaccine against the new H1N1 strain of flu ready for the northern hemisphere autumn after receiving seed virus samples, company officials said on Wednesday.

Sanofi-Aventis, GlaxoSmithKline, Novartis and Solvay all said their vaccine teams had obtained the new influenza A (H1N1) seed virus within the past fortnight, enabling them to begin the production process.

What is still unclear, however, is how much vaccine they will be able to manufacture, since this depends on how easily the new virus strain grows within a commercial production environment.

"It will probably take a couple of weeks to ascertain the yields before we get into large-scale manufacture," a Glaxo spokesman said.

The World Health Organization (WHO) said on Tuesday it was on the verge of declaring the first influenza pandemic in more than 40 years.

It is concerned at the sustained spread of the H1N1 strain -- including more than 1,000 cases in Australia -- following major outbreaks in North America, where it emerged in April.

Recent investment in flu vaccine capacity means companies are in far better shape to meet the challenge of a pandemic than in the past.

They are also well advanced in manufacturing supplies of the normal seasonal flu shot, allowing them to switch some capacity to making a pandemic H1N1 vaccine over the coming months.

Although the H1N1 flu strain seems mild at present, health officials are worried it might return in a more virulent form in the northern hemisphere winter.

The WHO estimates vaccine makers could produce 4.9 billion pandemic flu shots a year in the best-case scenario, though this will still not be enough for the entire world population of more than 6.5 billion, particularly if it turns out that people need more than one injection to gain immunity.

The 4.9 billion estimate would be significantly lower if there was no wholesale switch from seasonal to pandemic flu vaccine-making.

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sanofi-aventis to donate 10% of swine flu vaccine to who

http://afludiary.blogspot.com/2009/06/sanofi-aventis-to-donate-10-of-swine.html

some practice corporate responsibility and others don't.

the french drug maker sanofi-aventis has offered to donate 10% of their pandemic vaccine run to the world health organization for distribution to developing countries. the eventual number of donated doses could reach 100 million, although it would probably take several years to achieve that kind of donation. this offer is in response to a plea from director-general margaret chan that vaccine manufacturers not forget the plight of the developing world.

last week, the drug giant novartis indicated that they would not be willing to donate vaccine.

sanofi-aventis donating swine flu vaccine to who

by linda a. johnson, ap business writer

trenton, n.j. (ap) -- french drugmaker sanofi-aventis plans to donate millions of doses of swine flu vaccine to the world health organization for use in poor countries, chief executive christopher viehbacher said wednesday.

viehbacher said his company is making a "flexible donation" of a total of 100 million doses of vaccines against swine flu and bird flu.

the company had committed last june to donating 60 million doses of pandemic vaccine to protect people against the bird flu virus, a type designated as h5n1 influenza.

speaking at the pacific health summit, a meeting of global officials in science, industry, medicine, policy and public health in seattle, viehbacher said he wants to support the request of world health organization director-general margaret chan for common action in fighting the swine flu pandemic.

"exceptional times require exceptional responses. we need to act responsibly, and we all have to play our part," he said in a statement.

viehbacher said that once his company starts production of vaccine against swine flu, or h1n1 flu, it will reserve 10 percent of its output for the who to help fight the flu pandemic in developing countries.

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WHO welcomes Sanofi-Pasteur's donation of vaccine

http://www.flutrackers.com/forum/showthread.php?t=110982

Good publicity for Sanofi-Pasteur.

Sanofi-Pasteur to donate 100 million doses of influenza H1N1 vaccine to WHO

"We welcome this very generous gesture by Sanofi-Pasteur. One hundred million doses of vaccine against the pandemic H1N1 2009 virus is a sizeable and generous gesture to and on behalf of the world's less-developed countries. WHO will now work to ensure that this vaccine gets to groups who otherwise would have no access to pandemic vaccines.

"It is gratifying that vaccine manufacturers are demonstrating their solidarity with WHO in protecting the health of the world's poorer people: influenza knows no boundaries and so to protect people in one country is to protect us all."

Sanofi-Pasteur made its announcement of the donation of 100 million doses of vaccine at the Pacific Health Summit in Seattle, USA.

WHO Director-General Dr Margaret Chan will be speaking there tomorrow.

(hat tip flutrackers/ironorehopper)

Specializes in Telemetry & Obs.

http://www.newsobserver.com/news/health_science/story/1565873.html

There's a research group here in Raleigh testing the vaccine....y'all line up now!! :D

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