AFD - Vaccines - Studies and Developments

[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

October 8, 2008

South Korea Develops Human H5N1 Vaccine



# 2370


South Korean officials have announced that researchers in that country have developed an H5N1 vaccine for use on humans.


Given the length of this story, the lack of actual detail is remarkable. More precise information will hopefully emerge after the researcher gives his presentation on Friday.


Claims that - With the breakthrough, Korea can immediately produce vaccines with germ cells if the super flu breaks out. - read like `forward looking statements' from a prospectus.


Intriguing, but it's probably best to wait to see the fine print on this one.


In any event, here is how the Korean newspapers are covering the story. This from The Dong-A Ilbo.

H5N1 Human Vaccine Developed in Korea


OCTOBER 08, 2008 09:10

Korean researchers have developed a human vaccine for the highly pathogenic H5N1 subtype of the Influenza A virus.

Chungnam National University professor Suh Sang-hee said yesterday that his research team produced a human vaccine against the highly pathogenic bird flu strain by genetic recombination of H5N1 viruses transmitted to humans.

The team confirmed the vaccine?s effectiveness through ferrets that show the same symptoms as humans contracting flu viruses.

The vaccine is the first of its kind in Korea and the fourth in the world after the United States, the United Kingdom and Japan, said Suh.

Suh named the vaccine "CNUK-H5N1-08-01" and reported it to the government. He will present a thesis on the breakthrough in a symposium at the Korea Military Academy Friday.

His team in May became the first in Korea to obtain permission from the World Health Organization and the U.S. Centers for Disease Control and Prevention for dealing with human-infecting avian influenza germ cell lines. After gaining government approval for a biosafety level 3 to allow animal experiments, the team started vaccine development in July.

The vaccine is expected to protect the public from a ?super flu? pandemic.

Super flu occurs when H5N1 transmitted from birds mutates in a human body and becomes capable of infecting other humans. The 1968 Hong Kong flu killed more than one million people worldwide, the 1957 Asian flu two million, and the 1918 Spanish flu 50 million.

According to Suh, the efficiency of Tamiflu, an oral anti-viral drug used to treat influenza imported by domestic pharmaceutical companies, is unknown against a "super flu" outbreak. In addition, Tamiflu-resistant strains of H5N1 have emerged in Southeast Asia.

With the breakthrough, Korea can immediately produce vaccines with germ cells if the super flu breaks out. DNA sequences of super flu can vary, so stockpiled vaccines are 70 to 80 percent effective.


​

 

[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

Study: Bird Flu Vaccine -- A Double Jab Will Do Ya



# 2372


For several years it has been widely assumed that it would take two inoculations with an H5N1 vaccine, at least 4 weeks apart, to stimulate an adequate immune response in a recipient.


While there are various competing vaccines under development, early studies have shown that it has required a disappointingly high amount of antigen, and two shots, to confer a reasonable level of immunity.


While adjuvants may eventually help solve the high antigen requirements, the need for two shots could prove a logistical nightmare during a pandemic.


The idea of priming people before a pandemic with a `generic' H5N1 vaccine -and then providing them with a `booster shot' of a pandemic-specific vaccine when a pandemic erupts - is gaining traction.



Earlier this summer we learned of a study, published in the August edition of The Journal of Infectious Diseases , which showed that people who received an experimental H5N1 vaccine in Hong Kong 8 years ago developed a strong immune response after receiving a single booster shot of a clade 1 H5N1 vaccine.

Normally it takes two shots over a 30 day time span to achieve an acceptable immune response. In this case, a single `booster shot' produced an encouraging 64% immune response.
​

Japan, which has a sizable stockpile of pre-pandemic vaccine that is rapidly approaching the end of its shelf life, hopes to `store the antigen in people', by giving millions of essential workers a pre-pandemic jab. Their plan is to provide booster shots when a pandemic erupts.




Now we get word of a study from The University Of Leicester (UK) that suggests that people who were initially vaccinated years ago against the H5 virus, and are now given a booster shot, "are quickly protected against a broad range of avian strains following their booster vaccine, even strains they were not initially inoculated against."



If the author's conclusions are correct, then this would be a major development.

Here is the press release (reparagraphed and highlighted for readability)

New study determines double flu jab needed against bird flu pandemic


Scientists recommend stockpiling influenza vaccine


An international study led by University of Leicester researchers has determined that vaccination will be the best way to protect people in the event of the next influenza pandemic ? but that each person would need two doses.


In an article in the New England Journal of Medicine published on October 9, researchers from the University of Leicester and University Hospitals of Leicester report on a study carried out at the Leicester Royal Infirmary.


Dr Iain Stephenson, Consultant in Infectious Diseases at the Infirmary and a Clinical Senior Lecturer at the University of Leicester carried out the research with Professor Karl Nicholson, Professor of Infectious Diseases at the University of Leicester and Consultant Physician at the Leicester Royal Infirmary.


The research was carried out in collaboration with Katja Hoschler, and Maria C. Zambon of the Health Protection Agency, Kathy Hancock, Joshua DeVos, Jacqueline M. Katz, from the Centers for Disease Control and Prevention, Atlanta, Michaela Praus and Angelika Banzhoff, from Novartis Vaccine, Germany. It is published in a letter to the NEJM.


An influenza pandemic occurs when a new influenza strain emerges (one to which humans have no immunity), mutates and spreads globally as a virus. Although it is not possible to predict the actual pandemic influenza strain, global health authorities have identified H5N1 avian influenza as a strain with the greatest pandemic potential in humans.

H5N1 is currently circulating in birds and has caused serious illness in more than 380 people worldwide with a mortality rate, among people known to have been infected, of greater than 60 percent.


Dr Stephenson said: "In the event of the next influenza pandemic, vaccination will be the best way to protect people. Because of manufacturing capacity constraints, vaccines ideally need to be as a low dose as possible so that limited antigen material can be optimally used.


"In addition, it generally takes two doses of vaccine to give a good response, so if a pandemic occurred it would take some time to produce vaccine and then administer 2 doses to protect people. Therefore stockpiling of vaccines has been suggested to overcome some of these difficulties. However, subjects will still require 2 doses to generate protection and if the pandemic spreads rapidly this could be challenging to deliver."


The Leicester study looks at boosting those people who were vaccinated up to 7 years ago in the first H5 vaccine trials conducted in Leicester with a new updated H5 vaccine, in comparison to vaccinating subjects for the first time.


"We have found that a single low dose booster vaccine, given 7 years later, generated a very rapid response and within 1 week of vaccination, over 80% subjects had an excellent response to all strains of the H5 virus. In comparison, the unprimed subjects who were vaccinated for the first time needed two doses of vaccine and achieved protective levels of antibody after 6 weeks as expected.


The results indicate that regardless of which avian strain individuals are originally primed with, they are quickly protected against a broad range of avian strains following their booster vaccine, even strains they were not initially inoculated against.

These results potentially provide a rationale to prevent pandemic influenza by proactively immunizing the public with stockpiled pre-pandemic vaccines.


"Therefore the importance of this study is to help policy makers decide how to use the stockpiled vaccine. We find that proactively priming subjects (such as key personnel and first responders) to generate long lived memory immune responses that could be boosted rapidly many years later could be used as a potential vaccination strategy."

​

Conventional wisdom, for as long as I've been blogging on influenza, has been that a vaccine must be well matched to whatever mutated pandemic virus we end up facing.


That while a poorly matched vaccine might `prime' the immune system, it would require a closely matched booster shot to convey serious immunity.


This press release seems to indicate otherwise - intimating that broad protection against all H5 viruses was achieved - although I'm hesitant to read too much into the wording of a press release.


Even if a well-matched vaccine is required for a booster shot, the logistical advantage of only having to deliver one shot during a pandemic crisis, instead of two, would be immense.


There are many considerations that may prevent this priming strategy from being used for the general population; including the costs of vaccinations, and the potential liability for side-effects.


But for high risk groups, such as first responders and medical personnel, this may be an attractive option.


All in all, a tantalizing bit of news.

 

[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

China To Produce H1N1 Vaccine



# 3310


As punctuation to the level of concern around the globe over the emerging H1N1 virus, China has announced their intention to begin work on a pandemic vaccine for the fall.

This People?s Daily Online article indicates that, under optimum conditions, China could produce as many as 360 million doses of vaccine in a year.

There are still many unanswered questions regarding the immune response to any H1N1 vaccine, the amount of antigen required, and whether it would require one shot or two to convey immunity.
​

Even under the most generous scenario, China could produce only enough vaccine for about 1 person in 4 in their nation.

The real number is likely to be considerably less.

China starts batch production of A/H1N1 vaccine
Sinovac Biotech Company, a vaccine-focused biotech company in China, started efforts to manufacture A/H1N1 influenza vaccine for human use on Monday, after it received the flu strain samples from the WHO, reported Beijing News Tuesday.

There are another 10 Chinese drug companies that will obtain the flu strain samples "NYMCX-179A" from the WHO this week. China has a total of 11 drug companies that can produce seasonal flu vaccines, but Sinovac Biotech Company is the only one that can make pandemic flu vaccines.

On Monday, Sinovac Biotech Company announced it will share key techniques and cooperate with other flu vaccine producers in a bid to rapidly expand the vaccine production.

Also on the same day, the State Food and Drug Administration held a press conference, announcing it will organize and coordinate 11 drug companies in manufacturing vaccines in case of a pandemic of A/ H1N1 influenza.

Head of the biology production department under the State Food and Drug Administration, Yin Hongzhang, ensured the vaccines, which could be directly injected into the high-risk population, would be yielded by October 1. But he added that the experiments on the vaccine's safety and effectiveness are necessary before batch production.

Yin Hongzhang also predicted in case of a global epidemic, China's annual vaccine production capacity is expected to reach 360 million if all the eleven domestic drug companies are approved for the batch production of A/H1N1 vaccines.

Earlier, the drug administration noted that the WHO was not sure yet whether the A/H1N1 flu should be categorized as seasonal or pandemic, which was a problem for drug makers.


​

 

[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

Flu Vaccines: A Tough Sell



# 3399


The uptake of influenza vaccines in the United States and Canada is pretty low, with just over 1/3rd of Americans getting shots, and slightly less than 1/3rd of Canadians taking the jab.

Even more concerning is the very demographic ? teenagers and young adults ? who are the most severely affected by this pandemic strain are traditionally the least inclined to get a flu shot.

Complicating matters, it will probably take two shots, 3 or 4 weeks apart, to convey immunity.

That means 2 visits to a clinic.

Which may be a tough sell after all we?ve heard from officials about how `mild? this virus is and how `it?s no worse than seasonal flu?.

How receptive the public is going to be to any mass immunization plan is going to be a big question.
​

The Canadian Press has the results of a recent poll showing the rates of vaccination from last flu season.

Flu shot data points to swine flu challenge: Young adults don't get flu shots

Fri, 2009-06-26 12:28.
By: THE CANADIAN PRESS
TORONTO - New data on who got a flu shot in Canada last year underscores a challenge public health officials may face as they plan for a mass swine flu vaccination campaign: most young adults don't get flu shots.

Just under a third of Canadians aged 12 and older got a flu shot last year, Statistics Canada reported Friday in data drawn from the Canadian Community Health Survey, an annual effort to collect health information on a broad cross section of Canadians.

But that average was drawn upwards by the fact that 67 per cent of people 65 and older were vaccinated against influenza last fall.

The rates were substantially lower among people in their teens, 20s, 30s and 40s - the group which currently appears to be at highest risk of catching the novel H1N1 flu virus and of having severe disease or dying if infected.

Only 26 per cent of those aged 12 to 64 took the preventive seasonal flu vaccine in 2008, Statistics Canada said.

Among healthy males, about 21 per cent of teens, 15 per cent of those 20 to 34 and 19 per cent of those aged 35 to 49 had a flu shot. Among healthy females, the rates were a bit higher in most age categories: just over 20 per cent of teens, 23 per cent of 20 to 34 year olds and 25 per cent of those aged 35 to 44 got a flu shot.

(Continue . . .)
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[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

The Critical Path To A Vaccine



# 3401

In my post-paramedic career I was an estimator and project manager on a number of large commercial construction projects.

One of the skills you learn is Critical Path Analysis and the use of PERT (Project Evaluation and Review Technique) and Gantt Charts (a bar chart that illustrates a project schedule)

A sample Gantt chart is depicted below, followed by a PERT chart.





These complex appearing charts can often mean the difference between success and failure of an entire project.

A few years later, when I became a computer consultant and custom software programmer, I found myself using the same techniques when I was designing large software projects.

In any complex project there are steps, or actions, that can only be taken once other steps have been completed, while others can run in parallel.

When building a house, you can?t pour the slab until the plumber has roughed in the plumbing and the building inspector has signed off on it.

But you can schedule the drywall and the landscaper at the same time. And you can have the roofer putting on shingles while the electrician is roughing in the wiring.
​

Of course, you could just wait and do each item in sequence. But you lose precious days, weeks, or even months that way, and for most projects, that would mean prohibitive cost overruns.

Which is why the CPM (Critical Path Method) is so important.

And when you are talking about rolling out a massive vaccination program against a novel influenza, wasted time could cost many lives.

First, a news article about the proposed vaccination program for the United States, and then some thoughts about the critical path to getting it done.

Massive Swine Flu Vaccination Campaign Being Discussed

Posted on: Saturday, 27 June 2009, 06:35 CDT

According to officials, an unprecedented 600 million doses of swine flu vaccine may be given this fall even though officials have not yet developed a way to administer such a large number of shots.

The campaign would be much larger than the normal 115 million doses of seasonal flu vaccine administered each year, said officials at a national vaccine advisory committee meeting.

Currently, no decision has been made as to whether the swine flu vaccination will take place.

According to health officials, the campaign could be here soon.

As many as 60 million doses of the vaccine could be ready for distribution by September, if the vaccine can be tested and produced.

Despite the unknowns, officials are preparing for a massive vaccination campaign, and are fearful that the illness could accelerate by winter. Discussions on the massive campaign dominated a three-day meeting of the Advisory Committee on Immunization Practices, which guides the U.S. on vaccination policies.

(Continue . . .)
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Despite the `forward looking? statements about delivering 600 million doses of vaccine to Americans this fall, an awful lot must happen before that can become even a remote possibility.

The projection of 60 million doses of vaccine ready for distribution in September is also highly speculative, given that we don?t have any animal or human studies yet, and we don?t know how much antigen will be required to invoke an immune reaction.

Until we know that, we can?t really know how many doses will be available, or when.

The CDC, to their credit, has continually resisted giving any timetable for the American public seeing mass vaccinations against the pandemic flu.
​

Although the first batches of vaccine have been ordered for about 20 million critical infrastructure workers, the decision to manufacture enough vaccine for the entire nation has not been made.

Why not?

First, until we have animal and human studies showing that this pandemic vaccine is safe and effective, you really don?t want to be ordering up 600 million doses of an unproven vaccine.

Second, until we know how much antigen is required (and whether it will take 1 or 2 shots per person), we don?t even know how much vaccine to order.

There?s a big difference between needing 300 million doses and 600 million.
​

Third, scientists are waiting as long as possible before ordering the bulk of the vaccine because they fear the virus could mutate over the summer, which might make any vaccine produced now less effective in the fall.

Fourth, we honestly don?t know how long it will take to produce enough vaccine for 600 (or even 300) million doses.

Suggesting that it could all be done `by fall?, as the above article does - given the global competition for available vaccine production runs - would seem to be more than a little optimistic.
​

Fifth, authorities aren?t quite sure how they can deliver up to 600 million doses of vaccine (assumes 2 shots, 3 weeks apart) to 300 million people in a short period of time.

And that?s on top of administering roughly 120 million seasonal flu shots.
​

It?s never been done before.

The last time it was tried, in 1976, it ended up being a public health debacle (see Deja Flu, All Over Again). No one is anxious to see a repeat of that fiasco.

Health Departments around the country have been hit hard by budget cuts over the past few years, and no one knows where the money and personnel will come from to accomplish this monumental task.

And assuming that high risk groups will be prioritized to receive the vaccine, that will add another layer of complexity to the program.

Tracking recipients, and possible adverse effects, adds another wrinkle.

With 50 states, and thousands of county health departments involved, there are an incredible number of logistical problems involved in any national vaccination program.


And Sixth, it isn?t clear how many Americans would be willing to take a swine flu vaccine.

The constant reminders from many officials that this virus is `relatively mild? and `no worse than seasonal flu? may come back to haunt officials in the fall, should they decide to push the vaccine. Especially if the virus picks up virulence.
​

How much sway the anti-vaccine crowd and the conspiratorial websites will have, is also unknown. But you can bet that they, and the media, will play up any reports of side effects from the vaccine.

Selling the idea that ? in addition to a seasonal vaccine, people need to get two pandemic jabs ? isn?t going to be easy.
​

The serpentine route to developing and deploying a vaccine to an entire nation is fraught with numerous twists and turns, and no one can foresee them all in advance.

I certainly can?t.

And even armed with the best PERT and Gantt charts they can devise, the planners in our public health departments can?t either.
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In an extraordinarily complex operation such as this, there are simply too many opportunities for problems to arise, and delays to occur. Which is why the CDC is wisely refraining from making promises regarding delivery of a vaccine.

Despite these (and many other) obstacles, I remain in favor of developing and deploying a swine flu vaccine this fall.

I bring up these issues, not to discourage a vaccine, but to make sure people have a realistic idea of what they can . . . and can?t . . . expect this fall.
​

I fully expect that, barring some major problem in the clinical trials, some quantity of pandemic vaccine will be available this fall. I further expect that over the winter, more vaccine will become available.

How much?

I don?t think anyone knows right now. Hopefully enough to protect those at greatest risk from this virus.

But I wouldn?t put much money on the idea that ? as the above article suggests ? 600 million doses of vaccine could be given to all 300 million Americans this fall.
​

Call me a cynic, but I just don?t see a path that gets that done by the end of this year.

 

[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

Branswell On The Adjuvant Controversy


# 3416


Memories of the Swine Flu vaccine debacle of 1976 run pretty deep among public health officials, and politicians, here in the United States. Even those who are too young to actually have been a part of that event have certainly heard the cautionary tales.

For reasons still unexplained, a significant number of adverse side effects cropped up among people taking the vaccine. Most notably, Guillain-Barr? Syndrome (GBS), which causes a form of paralysis.

When the anticipated pandemic failed to arrive, officials were left with more dead and damaged people from the vaccine than from the swine flu.

The lawsuits that followed, along with the political outfall, are well remembered to this day. (For more information, see Deja Flu, All Over Again)

All of this makes public health officials just a wee bit nervous when they contemplate another massive pandemic immunization drive. Vaccine technology is better and more reliable today, of course, and so a repeat of 1976 isn?t considered likely.

But that assumes we don?t do something different with this pandemic vaccine ? like add an adjuvant.
​

Adjuvants are chemicals that are added to vaccines to increase the recipient?s immune response, and can lower the amount of antigen needed in a vaccine. In Europe, adjuvants have been approved for some vaccines given to those over 65 for years.

For a world facing a major pandemic vaccine shortage, adjuvants are an attractive option. But not everyone is sold on the use of adjuvants, particularly for children and teenagers.

Helen Branswell picks up the story over this debate. Follow the link to read it in its entirety.

Canada-U.S. may go different routes on pandemic vaccine production


By: Helen Branswell, THE CANADIAN PRESS
30/06/2009 2:50 PM | Comments: 0

TORONTO - Canada and the United States may go separate ways when deciding whether powerful boosting compounds called adjuvants should be added to swine flu vaccines, experts suggest.

Canada will likely use adjuvanted swine flu vaccine, says Dr. David Butler-Jones, head of the Public Health Agency of Canada.

But it is not a slam-dunk that regulatory authorities south of the border will clear adjuvanted flu vaccines for a U.S. mass vaccination campaign - if one takes place - this fall, some American experts say.

"The risk-benefit of using an adjuvant in a population in which you don't have a lot of data, i.e. younger people . . . has to be balanced against ... what's going on," says Dr. Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases.

"What's going on in our summer here? In the Southern Hemisphere's winter there? All of those things are going to be playing into the decision of what you're going to use or not use."

Ultimately decisions on whether to license pandemic vaccines with adjuvants will be the job of each country's regulatory agency - Health Canada here and the Food and Drug Administration in the U.S.

They and sister agencies elsewhere will face tough decisions in the weeks ahead, decisions that will likely have to be made with less data than such bodies typically require for the licensure of new vaccines or drugs.

(Continue . . . )
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[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

Branswell: Swine Flu Vaccine Yield Less Than Optimal


# 3477

One of the persistent rumors mentioned by flu reporters and bloggers for more than 2 months has been that the seed viruses being used to manufacture the swine flu vaccine aren?t growing particularly well in eggs.

Ten weeks ago, Maryn McKenna ? writing for CIDRAP ? in a piece entitled Path to swine flu vaccine has major hurdles, wrote:

Rumors are circulating among some flu scientists that the strain being used at the CDC for the vaccine seed strain is not growing well in eggs. The WHO and CDC appeared to acknowledge this Friday, disclosing that they are preparing two seed strains for manufacturers: one that was naturally reassorted by allowing viruses to mix in eggs, and another tuned via a patented process called reverse genetics that cuts and pastes genes from the swine virus with a non-pathogenic virus in order to achieve the highest possible growth rate. Manufacturers will be allowed to choose, the agencies said.
​

In my own article from early May, called A Vaccine Reality Check, I listed a number of possible obstacles to seeing large amounts of vaccine in the fall. One of them was:

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

Since then, there have been fleeting mentions by other reporters, and statements from the WHO regarding the need to incorporate dose-sparing (read: adjuvant) technology ? which suggested yields might be suboptimal. But nothing definitive.

Tonight Helen Branswell of the Canadian Press brings us a long and informative article with news that the virus yield from egg based manufacturing has been 1/2 that normally seen with seasonal flu viruses.

Unless this problem can be overcome (they are working on it), the amount of antigen available to make vaccines this fall and winter is likely to be far below what was originally hoped for.

As always, Ms. Branswell does a terrific job bringing us the details. Follow the link to read the article in its entirety.

Swine flu vaccine production hits a snag: yield so far is 'less than optimal'
By Helen Branswell ?

TORONTO ? Swine flu vaccine production has hit a snag, with manufacturers reporting a disappointingly low yield when vaccines viruses are grown in eggs.

The World Health Organization says so far the yield for egg-based production is half or less what manufacturers get when they make vaccine to protect against seasonal H1N1 viruses. The lion's share of influenza vaccine is made by companies that grow the viruses in eggs.

New seed strains are being made in the hopes of increasing the vaccine yield, a report by the WHO's vaccine chief, Dr. Marie-Paule Kieny says.

But if the yield cannot be increased, it will slow the rate at which pandemic vaccine comes out of the production pipeline, adding to the time it takes to protect populations in countries like Canada that have purchased vaccine. And countries that haven't pre-ordered pandemic vaccine would face substantial delays before manufacturers have product to sell to them.

"There's nothing to suggest it will take longer to make vaccine, if in fact everything goes as planned. The question is: How much?" says Dr. Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.

"There is nothing magical about making this virus. The questions will be: How much? When? and Where will it be available?"

The yield problem is revealed in presentations WHO staff made to last week's special meeting of the expert panel that advises the Geneva-based global health agency on vaccine issues.
(Continue . . .)
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[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

Branswell On Possible Fix For Low Yield Vaccine Production


# 3594


Helen Branswell brings us a detailed story tonight on new hopes that a seed strain of the novel H1N1 virus, developed in a British Lab, may solve the low-yield problem that most manufacturers have been battling this summer.

Ms. Branswell is one of the best science reporters in the world, so I?ll simply get out of the way.

Follow the link to read the entire article.

Possible fix found for problem of low yield in pandemic vaccine production
By Helen Branswell Medical Reporter (CP)
A British laboratory may have found a fix for the low yield problem that has been plaguing companies making swine flu vaccine, a scientist from the lab revealed Wednesday.
John Wood of the U.K.'s National Institute for Biological Standards and Control said an improved version of the seed strain his lab produced in May seems to generate a virus yield that is on a par with what manufacturers get when they make seasonal flu vaccine.
While Wood cautioned the increased yield has to be confirmed by manufacturers, any improvement would be welcome news. Manufacturers have been clamouring for the new seed strain, which the lab started shipping out Wednesday.
(Continue . . .)

 

[sharon sanders]

Re: AFD - Vaccines - Studies and Developments

WHO Pandemic Briefing # 6: Vaccine Safety



# 3595

A monograph from the WHO this morning designed to allay the public?s fears over the fast tracking of a pandemic vaccine.

This is going to be a huge issue this fall and winter, with the internet anti-vaccine propaganda machine already railing against taking the pandemic jab.

`Selling? the idea to the public that a fast tracked and largely untested vaccine is safe will require more than just a `trust us, we know what we?re doing? message such as the one below.

But every information campaign has to start somewhere.
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I expect that the heavy lifting on this matter will be left to each country?s public health department. No doubt the CDC and HHS will unveil a number of pro vaccination PSA (Public Service Announcements) this fall.

The real challenge will come once vaccinations begin, and the inevitable claims of adverse reactions start to appear in the press and on anti-vaccine websites.

Some will be legitimate, of course.

Flu vaccines have been known to cause rare, but sometimes serious, side effects. An increased incidence of Guillain-Barr? syndrome (GBS) was linked to the 1976 swine flu vaccine, with more than 400 cases reported and 25 deaths.

But many reports will simply be coincidental to taking the vaccine.

Since pregnant women are a high risk group, they are at the head of the line when it comes to taking the vaccine.

Normally, somewhere between 10% and 20% of all pregnancies end in miscarriage. Most of these spontaneous miscarriages occur in the first trimester.


How many of these will occur in the weeks following vaccination?
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Quite a few I should imagine. Probably thousands in the United States alone. And I?m guessing that the vaccine will be presumed guilty, without any scientific foundation, by a lot of people.

Bad publicity could seriously erode public health?s ability to dispense any pandemic vaccine, which makes public education on these matters (along with providing a safe vaccine) of paramount importance.

Here then is the WHO?s first salvo in what I expect to be a long, and bitter, public relations war.

Safety of pandemic vaccines

Pandemic (H1N1) 2009 briefing note 6

6 AUGUST 2009 | GENEVA -- WHO is aware of some media reports that have expressed concern about the safety of vaccines for pandemic influenza. The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.

Vaccines are among the most important medical interventions for reducing illness and deaths during a pandemic. However, to have the greatest impact, pandemic vaccines need to be available quickly and in large quantities.

During the 1957 and 1968 pandemics, vaccines arrived too late to be used as an effective mitigation tool during the more severe phases of the pandemics. Influenza vaccines had not yet been developed when the 1918 pandemic swept around the world, eventually killing an estimated 50 million people.

In 2007, as part of preparedness for an influenza pandemic, WHO worked together with health officials, regulatory authorities, and vaccine manufacturers to explore a broad range of issues surrounding the regulatory approval of pandemic vaccines. [1]

Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines. Different regulatory pathways were assessed, and precautions needed to ensure quality, safety, and effectiveness were set out in detail.

Fast-track procedures for approval

Regulatory authorities have shown great flexibility in developing procedures for fast-tracking the approval and licensing of pandemic vaccines.

In some cases, pandemic vaccines are not regarded by regulatory authorities as entirely ?new? vaccines, as they build on the technology used to produce vaccines for seasonal influenza, established procedures for testing and regulatory control, and an extensive body of safety data.

In such cases, approval procedures are similar to those applied to ?strain changes? made each year when seasonal vaccines are modified to match circulating viruses in the Northern and Southern Hemispheres.

Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.

In the European Union, the European Medicines Agency uses a rolling review procedure whereby manufacturers can submit sets of data for regulatory review as they become available, without having to wait until all data can be submitted together in a single formal application.

Also in Europe, some manufacturers have conducted advance studies using a so-called ?mock-up? vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.

Special safety concerns

Influenza vaccines have been used for more than 60 years and have an established record of safety in all age groups. While some serious adverse events have been reported, these have been rare.

Nonetheless, special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.

Some adverse events will be coincidental ? that is, associated in time with vaccine administration, yet not directly caused by the vaccine. Genuine adverse events directly caused by the vaccine may also occur, but cannot be predicted in advance. Given the safety record of seasonal vaccines, such events are expected to be rare.

Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.

For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans in place for doing so. On the positive side, mass vaccination campaigns can generate significant safety data within a few weeks.

International sharing of data from such post-marketing surveillance will be vital in guiding risk-benefit assessments and determining whether changes in vaccination policies are needed. WHO has developed standardized protocols for data collection and reporting in real-time, and will communicate findings to the international community via its web site.
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[1] Regulatory preparedness for human pandemic influenza vaccines. Report of a WHO Expert Committee on Biological Standardization. Geneva: World Health Organization, 2007 [pdf 625kb]
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