Any News on a Vaccine Yet?

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Haven't been following all these threads until recently. What is the news on a possible vaccine for H1N1 before the winter season hits? Please pardon me if this information has been already posted.

I normally forgo annual influenza immunizations due to the fact that A) I never contract the flu, and B) I have an autoimmune condition that may be exacerbated by immunizations.

After reading some of the information in this forum, especially the possible mutation of the virus into a deadlier form (like its eery 1918 prototype), I will take this vaccine (if offered) and urge others in my family/ circle of influence to do so.

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Fight for Swine Flu Vaccine Could Get Ugly

http://www.google.com/hostednews/ap/article/ALeqM5i7gN7uEKsp5QNVnXNLF0JCVT6FOAD99FJ6003

Here is part of the article:

An ugly scramble is brewing over the swine flu vaccine-and when it becomes available, Britain, the United States and other nations could find that the contracts they signed with pharmaceutical companies are easily broken.

Experts warn that during a global epidemic, which the world is in now, governments may be under tremendous pressure to protect their own citizens first before allowing companies to ship doses of vaccine out of the country.

That does not bode well for many countries, including the United States, which makes only 20 percent of the flu vaccines it uses, or Britain, where all of its flu vaccines are produced abroad.

"This isn't rocket science," said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota. "If there is severe disease, countries will want to hang onto the vaccine for their own citizens."

Experts say politicians would not be able to withstand the pressure.

(hat tip flutrackers/St. Michael)

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I need to find the link to post, but there is a story breaking on the wire services that the National Biodefense Safety Board is going to recommend "fastracking" the H1N1 vaccine. From what I understand, the NBSB advises the Department of Health &Human Services. The first doses will be ready by mid September and will bypass all but preliminary safety trials. Pretty scary stuff. I would have a hard time vaccinating my daughter with a vaccine that has not been upheld to stringent testing.

Also, Novartis AG is reporting that this particular strain yields smaller amounts of antigen. This means less vaccine supplies.

I'll try to link both articles.

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CDC Teleconference On Vaccine

http://afludiary.blogspot.com/2009/07/cdc-teleconference-on-vaccines.html

On Friday there was a CDC Teleconference for reporters on vaccines. For the full story of out what they had to say follow the link.

Clinical trials are expected to take about 2 months to complete, which presumably puts us into early October before any vaccines would be approved for use.

On July 29th a special, off-cycle meeting will be held to discuss whether prioritization and `tiers' make sense should vaccine supplies be severely limited.

Amid reports that some manufacturers, who are using the old egg-based technology to grow the virus, are seeing `suboptimal' yields, the CDC's Dr. Shuchat stated that they planned for `a variety of scenarios' and that nothing they've heard yet leads them to believe that the yield won't fall within the range they've anticipated.

Dr. Schuchat did caution, however, that vaccine manufacturing was always prone to `surprises'.

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CIDRAP Covers the NSBS Story

http://afludiary.blogspot.com/2009/07/cidrap-covers-nbsb-meeting.html

An expert panel that advises the Department of Health and Human Services (HHS) today supported the idea of moving quickly on pandemic H1N1 vaccine production with a goal of having "tens of millions of doses" available in September instead of October.

Discussing vaccine issues during a public teleconference today, the National Biodefense Science Board (NBSB) favored the idea of asking vaccine makers to start the final production steps for their H1N1 vaccines on Aug 15--before the first data from safety and immunogenicity trials will be available.

Last week, HHS Secretary Kathleen Sebelius said it was expected that the first H1N1 doses would be ready for distribution in mid-October. HHS has yet not made a formal decision to go ahead with a vaccination campaign, but Sebelius said the step was likely.

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Some links to articles in the UK discussing concerns about safety for the new vaccine.

http://www.independent.co.uk/life-style/health-and-families/health-news/safety-questions-over-swine-flu-jab-1751547.html

http://www.independent.co.uk/life-style/health-and-families/health-news/bid-to-calm-fears-over-untested-swine-flu-vaccine-1751927.html

Rational thinking from Avian Flu Diary on why it is still a good idea to get the vaccine. Check it out:

http://afludiary.blogspot.com/2009/07/flu-math.html

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Unlike UK officials, US says swine flu vaccine several months away from use

http://chealth.canoe.ca/channel_health_news_details.asp?news_id=28549&news_channel_id=1020&channel_id=1020

Here is an excerpt from a very good article written by Helen Branswell, one of the best at medical reporting.

"We are glad to have CSL having rushed so much to start into trials because we will have results of their vaccine by September," Kieny said in an interview.

She said the Australian company will test two dose sizes - 10 micrograms and 30 micrograms - and will also study whether a protective immune response could be achieved with one dose, or if two would be needed. The company is not testing vaccine with an adjuvant, a compound that boosts the impact of a flu shot so that smaller shots can be used.

As they grow up enough vaccine for pilot lots, other manufacturers will follow suit.

"We expect initial trials to be starting very shortly," Dr. Jesse Goodman, chief scientist and acting deputy commissioner of the U.S. Food and Drug Administration, said Friday during a teleconference organized by the U.S. Centers for Disease Control.

Goodman cautioned, though, that these studies will take a couple of months to conduct.

"We're anticipating that even if things go well, we're not going to have the data for some time," he said.

Canadian authorities and the country's pandemic vaccine contractor, pharmaceutical giant GlaxoSmithKline, have not, so far, shared details of the clinical trials that will be conducted in Canada.

But the head of the Public Health Agency of Canada, Dr. David Butler-Jones, has repeated said the country doesn't expect to roll out a pandemic vaccination program until late October.

Butler-Jones has also said Canada's vaccine will include adjuvant. GSK has a powerful proprietary adjuvant it has used to impressive effect in studies of experimental H5N1 avian flu vaccines.

Whether the U.S. will go that route, however, remains in doubt. The comments of a number of American officials create the strong impression that if the U.S. can meet its needs without using adjuvants, it would prefer to leave them out.

(hat tip crofsblogs)

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They are now going to give immunity from prosecution to flu vaccine makers. I understand that they want more companies to make the vaccine but I'm afraid that if you give them immunity they will get sloppy on how they're making their vaccines.

http://www.google.com/hostednews/ap/article/ALeqM5hjdCHrP82YTFser5vD6CzTK1az6wD99GH8580

ATLANTA-The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it's worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It's likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn't been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.

"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.

Vaccines aren't as profitable as other drugs for manufacturers, and without protection against lawsuits "they're saying, 'Do we need this?'" Sugarman said.

The move to protect makers of a swine flu didn't go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

"If you're going to ask people to do this for the common good, then let's make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.

AP Medical Writer Lauran Neergaard contributed to this report from Washington.

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Studies aim to answer key questions as world readies for swine flu vaccination

http://chealth.canoe.ca/channel_health_news_details.asp?news_id=28561&news_channel_id=1020&channel_id=1020

A flurry of innovative vaccine trials is in the offing as governments and regulatory agencies prepare for the probable launch of mass swine flu vaccination programs in the fall.

The results of the trials could determine whether people with egg allergies can be offered pandemic (and regular) flu vaccine, whether pandemic and seasonal flu shots could be given at the same time and whether one company's vaccine can be given with another's adjuvant, a compound that boosts its potency.

Vaccine manufacturers are either unable or unlikely to undertake the complicated studies required to answer these questions. Governments will fund the work instead.

Infectious diseases expert Dr. Anthony Fauci says the goal here for organizations like the U.S. National Institute of Allergy and Infectious Diseases - which he heads - is to fill key knowledge gaps for vaccine regulators.

"What are they going to need that somebody else can't do?" Fauci explains.

Some of those priorities will be aired Thursday in Washington when the U.S. Food and Drug Administration's vaccine and related biological products advisory committee meets in a session on clinical trials for pandemic vaccines.

Vaccine manufacturers will do the basic testing, work designed to assure regulators and would-be recipients that their vaccine is safe and likely to protect against the pandemic strain, an H1N1 virus of swine origin.

But there are many other key questions. In fact, the list is too long to tackle in its entirety in the limited time available.

So discussions between planners and regulators over the past few weeks have led to a paring down of priorities. In the case of the U.S., it's not yet clear which studies have survived the cut.

However, Fauci says his institute will green-light one looking at whether the pandemic vaccine - to protect against the new H1N1 virus - could be given at the same time as seasonal flu vaccine, which protects against three types of flu viruses including a different H1N1.

Co-administration, as it is called, would make the logistics of pandemic vaccine delivery much easier - if the pandemic vaccine is ready in time. But would giving people vaccines that protect against two different H1N1 viruses at once actually undermine the effort by weakening the response to one or both?

"As an immunologist, I don't think you're going to have any trouble with that. But you don't know," Fauci explains.

"Would presenting two different H1N1 antigens to the body at the same time result in antigenic competition? On the other hand, we could be surprised and giving them together might enhance the response to both."

In Canada, plans are underway to try to test whether people with egg allergies could be given flu shots containing vaccine produced in eggs. Currently that is considered unsafe and is not done.

With some manufacturers moving to grow their vaccine viruses in cell culture, that may be less of a problem in the future. But for now egg-based production still generates the lion's share of of the global flu vaccine output. Canada's entire supply will be egg-based vaccine.

Dr. Scott Halperin, a vaccinologist from Dalhousie University in Halifax, says a newly formed, federally funded research network hopes to get ethics approval to test the assumption it is unsafe to give people with egg allergies flu shots.

The goal will be "to basically look at what is the real risk, and to immunize individuals under very carefully controlled (circumstances)," says Halperin, principal investigator of the Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network.

"That is a real concern," he says of the current position on people with egg allergies. "You can't leave a whole segment of the population without access to protection."

Another question regulators in the United States and possibly some other countries need answered relates to the use of adjuvant. Specifically, they'd like to know whether one of the powerful new adjuvants made by companies like GlaxoSmithKline and Novartis could be used with antigen (vaccine) made by a company that currently doesn't market adjuvants, such as Sanofi Pasteur.

This type of study - called "mix and match" by those involved in the planning - won't have an impact in Canada. GSK has the contract to provide all of Canada's pandemic vaccine and is producing adjuvanted pandemic flu shots.

And the findings may not be put into application in the U.S. either, if it is shown that swine flu vaccine on its own will produce an adequate immune response. U.S. officials have repeatedly hinted they may forgo use of adjuvant if it isn't needed to get the job done.

But the U.S. has planned for contingencies, buying bulk adjuvant in case there isn't enough vaccine and supplies need to be stretched. Having some evident for the FDA that mix and match would work means the backup plan could be activated if needed.

"Nobody's going to do that (trial) but us," Fauci says. "I can tell you that for sure."

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He did mention no:uhoh21: 'serious adverse' effects but what were the 'adverse' effects-he knew we would wonder right?

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Australia - Human Trials of Vaccine Begins

http://afludiary.blogspot.com/2009/07/australia-human-trials-of-vaccine-begin.html

http://news.yahoo.com/s/ap/20090721/ap_on_re_as/as_australia_swine_flu

Tomorrow CSL Ltd will begin the first round of human testing of their H1N1 pandemic vaccine. This limited test will involve 240 volunteers, and should give us . . . perhaps a month from now . . . the first working data on how well the vaccine protects.

The two things we are most interested in from these human studies are the safety of this vaccine, and the most appropriate dose. Since the antigen needed to make the vaccine will be in short supply, the lower the dose, the more people that can be vaccinated.

Right now, it is anticipated that it will take two shots . . .3 to 4 weeks apart, to generate sufficient immunity. This study should help answer that question regarding the CSL vaccine, and probably give us some clues over how other vaccine candidates will behave.

The safety question is one that will be more difficult to ascertain. Generally, serious side effects only appear in 1 out of 10,000 or perhaps 1 out of 100,000 people.

Detecting that kind of a rare reaction with a sample of just a few hundred people is unlikely. Luckily, flu vaccines usually have a low incidence of adverse side effects. The notable exception of course was 33 years ago.

During the 1976 swine flu vaccination program (see Deja Flu, All Over Again) as many as 500 recipients (out of 40 million people) developed a rare neuromuscular disease, and 25 died.

There are hopes that the world can deliver several billion doses of flu vaccine to the arms of its population over the next 12 months, a feat that has never been attempted before.

With that many people receiving jabs, it is likely that at least a few hundred serious vaccine-related side effects will be generated.

We really won't know exactly how safe or effective this (or any) vaccine is until it has been given to millions of people, and proper surveillance and follow-up has been done.

There are no guarantees in life, and certainly no guarantees when it comes to vaccines. Like all drugs, even aspirin, there is a risk - reward tradeoff involved.

In most cases, however, the risks of getting influenza far outweigh the risks of getting the vaccine (see Flu Math).

This year, of course, there are a couple of complicating factors.

First, some countries intend to use adjuvants, or proprietary immune boosters, to lower the amount of antigen required to immunize someone.

Adjuvants have been used to boost the effectiveness of flu vaccines in the elderly in Europe, but have not been widely used in young adults or children. Some doctors and scientists have expressed concerns over their use, particularly in children, until more studies are conducted.

The United States, while purchasing adjuvants, seems reluctant to use them unless it is deemed absolutely necessary.

Second, normally it takes several months of human trials, and analyzing data, before a vaccine is certified for use. There are plans in some countries to try to `fast-track' this process, in order that vaccinations begin as soon as possible.

While it is unlikely that serious problems will crop up with this vaccine, we really won't know until it has been given to millions of people.

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Efforts to improve swine flu vaccine yields drawing a blank, experts warn

http://ca.news.yahoo.com/s/capress/090721/national/flu_vaccine_woes_1

It may take substantially longer to make the full amounts of swine flu vaccine countries have contracted to buy because efforts to improve the yield of the vaccine seed strains aren't bearing fruit, experts say.

Three of the laboratories involved in the work are sounding increasingly pessimistic that the yield problem can be fixed in the short term. Vaccine manufacturers have reported they are getting between 50 per cent and 75 per cent less vaccine with the new H1N1 virus as they do when they make seasonal flu vaccine.

"It's not looking very bright at the moment," John Wood, principal scientist at Britain's National Institute for Biological Standards and Control, said in an interview Tuesday.

"In effect, it means if we continue like this, manufacturers will have to keep on producing (pandemic) vaccine for longer to make the number of doses needed."

The flu laboratories at the U.S. Centers for Disease Control have made three new seed strains and are in the process of completing the paperwork needed to ship them to the manufacturers.

The head of the CDC's influenza division said while the new vaccine candidate viruses are growing well in the hands of her scientists, there's no guarantee they will produce a better yield when manufacturers start to work with them.

Dr. Nancy Cox said the issue isn't simply about growth, but also about how well the vaccine viruses hold up during the various steps of the manufacturing process.

"I think it is possible we won't have a better yielding virus," she admitted from Atlanta.

"(But) I think that it's still too early to say how this will impact the amount of vaccine that's available."

Each flu virus has its own characteristics and vaccine makers are accustomed to working with new strains, fine-tuning processes to try to coax maximum yield from a virus.

A spokesperson for vaccine giant Sanofi Pasteur said the company feels it hasn't yet exhausted efforts to improve the yield of the seed strain for the pandemic vaccine. Still, Len Lavenda suggested Sanofi doesn't expect those efforts to fully correct the problem.

"Although we think it's too soon to project what the final yield will be, we anticipate it will remain lower than seasonal vaccine yield," Lavenda said from Sanofi's headquarters in Swiftwater, Pa.

"Certainly if the yield doesn't increase it means it will take longer to produce the vaccine. (But) I think at this point in time we remain hopeful that we'll be able to increase the yield and think it's premature to throw in the towel, so to speak."

The various companies making pandemic vaccine have been working with a seed strain produced at New York Medical College in Valhalla, N.Y. Its laboratory pioneered the process of engineering vaccine viruses to maximize growth decades ago and scientists there have produced many of the vaccine seed strains used since.

Its first swine flu seed strain was overwhelmingly viewed as the best yielder by vaccine manufacturers. But even at that manufacturers said they got about half of the yield generated with seasonal flu production.

Doris Bucher, who heads the lab, says her team is trying other options, but they haven't seen anything promising yet. And she's heard manufacturers' efforts aren't paying off either.

"Usually they tweak it and it grows better. But it hasn't responded to tweaking. ... (That's) the feedback I'm getting."

Seed strains are hybrid viruses that have the surface genes of the virus the vaccine is meant to protect against merged with the internal genes of an old flu virus that is known to grow well in eggs.

Typically those hybrids - called reassortants - are made up of six genes from the high-growth virus with two genes from the target virus, which in this case is the new H1N1.

Seed strains can be made by two different processes. One, called the classical method, involves co-infecting growth medium with the two types of viruses and letting them swap genes on their own. The other involves a patented process called reverse genetics that essentially allows scientists to piece together the desired constellation of genes.

Bucher's first seed strain was made using the classical method, which means any vaccine made from it wouldn't require manufacturers to pay royalties for the seed strain.

But the new CDC-produced seed strains were made using reverse genetics. If manufacturers switch to use one of them, royalties for every dose of vaccine sold will be due to the U.S. vaccine company MedImmune, which holds the patent.

Bucher said her original seed strain was made with three genes from the swine flu virus and five from the high-growth virus. Her team is now trying to see if a six and two constellation would work better.

But she and others admitted the yield problem may be due to something inherent in the swine flu viruses.

"It possibly is," admitted Wood, whose lab also generated seed strains in the first round of production.

"This is unusual, having all the labs who usually do this work and there still being a less than satisfactory outcome. Usually, we get at least one virus which is good. Average to good. And this time none of them are."

(hat tip Avian Flu Diary)

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Canada: No Plans To Force HCW Vaccinations

http://afludiary.blogspot.com/2009/07/canada-no-plans-to-force-hcw.html

OTTAWA-The Public Health Agency of Canada has no plan to deal with front-line health-care workers who refuse to be vaccinated against swine flu, a scenario that some infectious-disease experts believe could accelerate the spread of the flu pandemic in the coming months.

The question of whether doctors and nurses should be forced to take flu vaccines has long been a contentious issue in the public-health community. In 2002, the Ontario government withdrew legislation that made it mandatory for paramedics to get flu shots, after the paramedics' union launched a legal challenge under the Charter of Rights and Freedoms.

The Canadian Medical Association, which represents tens of thousands of doctors nationwide, will introduce a resolution at its annual meeting next month that encourages physicians to get the swine-flu vaccine, which is expected to be ready in the fall. But the association will stop short of endorsing mandatory vaccinations, said CMA president Dr. Robert Ouellet.

"We think there should be informed consent," Ouellet said in an interview. "Everyone should have the right to refuse a vaccination if they think it's not right for them."

(Continue . . . )

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