Vaccine or lack of

[Eliza]

http://www.cbsnews.com/stories/2009/08/17/eveningnews/main5247937.shtml

Massive Shortfall Seen for H1N1 Vaccine

Officials Expected 120 Million Doses by October, but Now Say They'll Get Fewer than Half That Many;

Children First in Line

H1N1 Vaccine Timetable

With flu season approaching, the Centers for Disease Control says a vaccine for the dreaded H1N1 virus could be ready by October. But there may be less doses available.

Dr. Jennifer Ashton reports.


H1N1 Concern Grows as School Time Nears
Weighing Possible H1N1 Vaccine Risks

(CBS) The H1N1 flu virus is expected to make a comeback this fall. But America's timetable for treatment is changing. Health officials had predicted having 120 million doses of vaccine ready by mid October.

Now they say it will be more like 45 million. And with two doses needed to be effective, the nation's protection blanket will start out much smaller than the experts hoped, as CBS News medical correspondent Dr. Jennifer Ashton reports.

Just two weeks into a national testing program to see if the H1N1 vaccine is actually safe, comes word that there will be far fewer shots available in the fall, when a national vaccination program is scheduled to get started.

"We're in a race between vaccine and virus," said Dr. William Schaffner of Vanderbilt University Medical Center. "This gives the virus a bit more of an advantage. We'd like to start in as many people as soon as possible."

In July, it was projected that 120 million doses would be available by October, with another 80 million in the following months. Now, citing production delays, the government has been told by manufacturers that only 45 million doses will be ready by October 15, with approximately 20 million doses being delivered each week thereafter.

"The fact that we have fewer doses I think actually will focus attention," Schaffner said. "it will mean that we all will have to be much more specific about whom we will ask to show up."

The government says that it still expects to receive the same amount of vaccine as originally planned, just on a somewhat longer schedule. Experts say that now kids may jump to the front of the line.

Schaffner says that's both because children are more at risk to become sick from the virus - and because they're more likely to help spread it.


"Children excrete more virus. They are less hygienic. And they're very enthusiastic about kissing mom, dad, grandma, and aunt Susie," he said. "They are the great distributors."

[Eliza]

If this pandemic follows the parameters of the 1957 pandemic, the elderly will be perishing in large numbers during the winter.

I don't buy all of the previous MSM hoopla that the seniors have immunity.

Most of those who have died we're unfortunate souls that were suffering from chronic conditions.

The young, with healthy immune systems, should be the strongest and the most likely to survive.

The weak and elderly, the most likely to perish from secondary pneumonia if infected with H1N1.

Sounds as though Obama has already been implemented. Babysitters, have a higher priority to be vaccinated against H1N1 than the elderly.

Now, there isn't enough medicine in time. What happened?

Just my view.

[Eliza]

Australia pulls sovereign rank on drug maker delaying shipments to US.


HHS has long predicted it would have 120 million doses on hand by Oct. 15, but now expects just 45 million by that date. It now appears to be more of a delay than a shortage: More will arrive rapidly, about 20 million more doses shipped every week, by Robinson's new calculations.

Another supplier, Australia's CSL, recently notified the U.S. that its shipments will arrive later than promised because it first must provide batches to its home country, where the flu season is winding down. Although the U.S. signed a contract with CSL first, "there was always the possibility they could do that," Robinson said. "Our laws can do the same thing. We don't, but we could."

Dr. Robin Robinson, is the Department of Health and Human Services official in charge of vaccine procurement.

[Eliza]

Hmmmm.

www.anpa.org/Newsletter_063009_2.php - [Cached Version]
Published on: 6/30/2009 Last Visited: 8/6/2009
A lot, says Robin Robinson, PhD, director of BARDA, the Department of Health and Human Services (HHS) branch responsible for ensuring production, procurement, and delivery of biomedical supplies crucial to national preparedness.

If all goes as planned, Robinson says, manufacturers will have 60 million vaccine doses on hand at the end of October, with 100 million more doses by the end of November and 80 million more doses each month thereafter through March 2010.
...
Adding an adjuvant would delay vaccine production to November, Robinson says, although it might be possible to start making regular vaccine and then switching to production of the boosted product.
...
Robin Robinson, PhD, director, Biomedical Advanced Research & Development Authority; assistant secretary for prepardness & response, Department of Health and Human Services.

[Eliza]

Crucell wins $41 million flu contract from U.S. government

Tue Aug 18, 2009 2:54am EDT

AMSTERDAM (Reuters) - Dutch biotechnology firm Crucell said on Tuesday it had been awarded a $40.7 million U.S. government contract for the development of monoclonal antibodies for treating influenza.

Crucell said the contract from the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH) could be worth up to $69.1 million if additional funding is released by the NIH.

"With the world now at pandemic alert level six, and recent reports of A/H1N1 oseltamivir resistance occurring, the timing of this contract is extremely important" said Jaap Goudsmit, Crucell's chief scientific officer.

Crucell will be the primary contractor in the new NIH contract with additional services supplied by Quintiles Guys Drug Research Unit and RetroScree in London as well as Viroclinics and Central Veterinary Institute, both located in the Netherlands.

Crucell has been looking to tap market demand for effective treatment and prevention for both seasonal and pandemic influenza.

Last week it said it planned to kick off clinical Phase I studies of an experimental antibody-based flu drug next year amid strong government interest.

The company's chief executive, Ronald Brus, said clinical trials of its product mAb CR6261 will start in 2010, but the exact date depends on the regulatory authorities.

[Eliza]

UPDATE 1-Sinovac says one-shot swine flu vaccine effective

Tue Aug 18, 2009 11:09am EDT

* Chinese group first to complete H1N1 vaccine trial

* Single shot means more people can be vaccinated

* Sinovac shares up 10 pct

(Writes through, adds detail, shares, background)

LONDON, Aug 18 (Reuters) - An H1N1 swine flu vaccine developed by China's Sinovac Biotech (SVA.A: Quote, Profile, Research, Stock Buzz) is effective after just one shot, its developer said on Tuesday.

The news boosted shares in the Chinese vaccine company by 10 percent in U.S. trading.

Until now, experts have predicted that two shots will be needed to provide swine flu immunity. But Sinovac, which is the first company worldwide to complete clinical trials for an H1N1 vaccine, said a single dose of its vaccine proved sufficient.

Leading flu vaccine makers including Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz), GlaxoSmithKline (GSK.L: Quote, Profile, Research, Stock Buzz), Novartis (NOVN.VX: Quote, Profile, Research, Stock Buzz), Baxter (BAX.N: Quote, Profile, Research, Stock Buzz), CSL (CSL.AX: Quote, Profile, Research, Stock Buzz) and Solvay (SOLB.BR: Quote, Profile, Research, Stock Buzz) are racing to develop a vaccine against swine flu.

The H1N1 flu outbreak, which was declared a pandemic on June 11, has spread around the world and could eventually affect 2 billion people, according to the World Health Organisation.

Officials are concerned that supplies of vaccine will prove tight, but an ability to vaccinate people once instead of twice would stretch stocks substantially.

Sinovac said immunogenicity after one dose of its vaccine had "reached the international criteria for vaccines". There were no signs of severe adverse reactions, it added.

Its clinical trials were initiated in Beijing in July and inoculation was completed on Aug. 15, with a total of 1,614 participants over three years receiving the vaccine.

Regulators around the world are expected to start approving swine flu vaccines next month as more clinical trial results come in, allowing governments to start mass vaccination programmes from September, according to the WHO.

Medical experts say vaccines need to available quickly and in large quantities to have the greatest impact.

Vaccines arrived too late in the 1957 and 1968 flu pandemics to be of much use and flu vaccines had not been developed in the 1918 "Spanish flu" pandemic which killed an estimated 50 million. (Reporting by Ben Hirschler; Editing by David Holmes)

[Eliza]

FDA clears CSL's vaccine-finishing facility in US

Lisa Schnirring Staff Writer


Aug 18, 2009 (CIDRAP News) – The US Food and Drug Administration (FDA) today approved a vaccine filling and packaging facility in Illinois owned by CSL Biotherapies, one of the five companies under contract to make novel H1N1 vaccines for the United States, the company announced.

The facility, based in Kanakee, includes a high-speed,single-dose vaccine filling line and is intended to help the company expand its capacity to make flu vaccine for the US market. The company, based in Australia, said in a press release that it completed production of its seasonal flu vaccine, Afluria, in early July and will deliver more than 8 million doses, most of it in thimerosal-free prefilled syringes, for the upcoming season.

On May 29 CSL signed a $180 million contract with the US Department of Health and Human Services (HHS) to produce novel H1N1 antigen. Today's FDA approval will enable the company to package the antigen, produced at the company's headquarters in Australia, if requested by HHS. A company spokeswoman said in an e-mail sent to journalists today, "Today's approval of this facility is particularly important as it will allow CSL to fill and package their vaccine against the novel influenza A/H1N1 virus in the US."

On Aug 14 during a National Biodefense Safety Board teleconference to update US officials on pandemic preparations, an HHS official scaled back the predicted initial supply of novel H1N1 vaccine from 120 million doses to 45 million doses by mid October, with 20 million doses arriving weekly thereafter. The official cited a US shortage of vaccine fill-and-finish sites, which are just finishing production of seasonal flu vaccines, as one of the reasons for the vaccine delay.

Bill Hall, an HHS spokesman , told CIDRAP News today that the FDA's approval of CSL's new facility is clearly good news and is part of HHS's strategy to maximize vaccine production and speed delivery. "However, it's too early to predict at this point exactly how much this particular approval will enhance our overall production capacity and vaccine availability," he added.

Another reason cited for the reduced forecast regarding initial H1N1 vaccine supply was CSL's contractual obligation to produce novel flu vaccine first for its home country, Australia, which is in the midst of its winter flu season. Officials also said one of the companies making seasonal flu vaccine is having problems finishing up production.

When the Kanakee facility opens, it will have the capacity to fill and package 10 million doses of CSL's seasonal flu vaccine each year, the company said. Once the site reaches full capacity it will be able to fill and package 20 million thimerosal-free prefilled syringes annually.

Wally Casey, senior vice president and general manager of CSL's Kanakee facility, said in a press release that the FDA's approval today enables the company to rapidly deliver ready-to-administer flu vaccines to US healthcare providers. "It also underscores our support to enhance vaccine administration safety through the use of ready-to-use prefilled syringes," he added.

CSL said in a May 29 press release that it also has a fill-and-finish facility in Marburg, Germany.

[Eliza]

Posted on Tue, Aug. 18, 2009
Plans set for St. Louis County’s initial swine flu vaccine supply

ST. LOUIS | The first 100,000 batches of swine flu vaccine will be distributed in St. Louis County at the end of October, the county’s Health Director, Dr. Dolores Gunn, said Tuesday.

Gunn said emergency personnel and health care providers would get the first doses, followed by pregnant women and people under the age of 24. Any doses left from the original batch would then be distributed to the public at large.

Gunn said that after the initial stock is depleted, the federal government would continue to supply about 25,000 doses each week to meet demand.

“Ultimately, we have been assured that there will be enough doses so that everyone in the county who wants the vaccine will get it,” Gunn said Tuesday afternoon at a caucus meeting of the County Council.

Gunn said the federal government has pledged to give the county $3 million over the next three years for the vaccinations, but that it was not clear when the money would arrive.

In the meantime, Gunn has asked the council for permission to withdraw $450,000 from the health department’s emergency appropriations fund to pay for the inoculations.

Gunn said pregnant women and children are particularly susceptible to swine flu.

Clinical trials to test the vaccine’s short-term safety and effectiveness are currently under way at St. Louis University and seven other sites in the United States. The government expects to have about 160 million doses available this fall if the Food and Drug Administration gives final approval, which is expected.

Typically, someone who is immunized against a flu virus either will not catch it or get a milder case.

[Eliza]

Swine flu vaccine orders pass one billion: WHO

By Marlowe Hood

(AFP) –

PARIS — Northern hemisphere countries have so far ordered more than one billion doses of swine flu vaccine, the World Health Organisation said Tuesday, sparking warnings over shortages.

Some countries -- notably Greece, The Netherlands, Canada and Israel -- have ordered enough double doses to inoculate their entire populations.

Others, such as Germany, the United States, Britain and France, have put in orders that would cover between 30 and 78 percent of people.

"Pandemic vaccine orders put in by northern hemisphere countries stand at over one billion," WHO spokeswoman Melinda Henry told AFP.

"In the early days, there will be a very limited supply of vaccine. There won't be sufficient supply to vaccinate whole populations, or even huge proportions of populations," Henry said by phone.

Intense demand coupled with production delays could create shortages, forcing governments that are preparing for a second, possibly more deadly, wave of flu to make hard choices about who to vaccinate first, experts have warned.

In July, the WHO said that the 25 drug companies which had announced their intention to manufacture vaccines could crank out up to 94 million doses per week starting in mid-October.

The global health body revised these numbers sharply downward when the top half-dozen vaccine makers -- accounting for 85 percent of global production -- reported that the swine flu strains with which they were working did not reproduce as quickly as expected.

"The current vaccine strain would only yield 25 to 50 percent" of the original estimate, as low as 23 million doses per week, said Henry.

Clinical tests have not yet confirmed whether new strains under development will produce higher yields, and initial results for at least one, reviewed by WHO Tuesday, are not encouraging.

There remains a big question mark, Henry said, as to whether one or two doses will be needed for effective vaccination.

A Chinese drug company, Sinovac Biotech, announced Tuesday that it had completed clinical trials showing that its new vaccine "induces good immunogenicity after one dose."

But many experts have said that double doses will be needed because most people have no immunity to the so-called "novel" A(H1N1) virus.

A shortfall in supply would essentially oblige national health authorities to ration the vaccine.

US health officials said Tuesday they expected a large shortfall in swine flu vaccines, with only 45 million doses due to be ready in time for the start of a vaccination programme in mid-October.

Last month officials there said 120 million doses would be available to vaccinate those considered most at risk.

"Policy makers are still coming to terms with who the target groups should be," said Mark Miller, an epidemiologist at the Fogarty International Centre of the US National Institutes of Health.

Virtually all international and national health authorities say health sector professionals should be vaccinated first, because they are frequently exposed to the virus but above all to insure that health facilities can operate at maximum efficiency during peak periods of infection.

Beyond that, there are no universal guidelines.

"Individual countries have to look at their own conditions and adapt. They have to decide whether they want to stop transmission, protect essential infrastructure, or reduce illness and death," Henry said.

Each of these priorities imply different strategies, and entail protecting different sectors of society.

Some experts recommend vaccinating all school-age children and their parents to stop the flu from spreading, while others say vulnerable populations must be first in line.

But even knowing who is vulnerable is a problem, experts say.

Historically, during seasonal flu epidemics, priority has gone to the elderly and those with chronic diseases, such as asthma or other lung conditions.

"But we know from our research that it is actually younger populations which are more affected during pandemics -- it is one of the signature features of pandemics," Miller told AFP.

In a study published last August, Miller showed that each of the 20th century's major pandemics would have required a different vaccination strategy in order to save the maximum number of "years of life lost."

[Eliza]

August 19, 2009
State Requires Flu Vaccination for Caregivers

By ANEMONA HARTOCOLLIS
The State Health Department is requiring tens of thousands of health care workers across the state to be vaccinated for flu, amid fears that swine flu will return in the fall.

The new regulation, quietly adopted as an emergency on Thursday, affects workers at hospitals, in home health care agencies and in hospice care, but, because of a technicality in state law, not in nursing homes.

The regulation raised protest Tuesday from New York’s largest health care union, 1199 S.E.I.U. United Healthcare Workers East, whose president, George Gresham, said that the policy was “completely unprecedented” and could become punitive if the religious or cultural beliefs of workers prevented them from being vaccinated.

“Health care workers on the front lines of providing care deserve the dignity and respect of thoughtful consideration before a regulation like this can just be rushed through and put into effect,” Mr. Gresham said.

Until now, flu vaccination has been voluntary, and fewer than half of health care workers have been vaccinated in a typical season, state health officials said.

The new regulation, which requires vaccination against seasonal flu and the H1N1 virus, would affect workers and volunteers who come into direct contact with patients, including nurses, doctors and aides, and even nonmedical staff members like food service workers if they enter a patient’s room, a Health Department spokeswoman, Diane Mathis, said.

Ms. Mathis declined to comment on Mr. Gresham’s criticism, but said that health officials had met with the union and other professional associations to discuss the proposal before it was adopted.

She said that vaccination was “clearly a patient safety issue.”

[Eliza]

Opinion only!

The CDC should rethink its H1N1 vaccination strategy, study says

August 20, 2009 | 12:00 pm

The Centers for Disease Control and Prevention has recommended that when the H1N1 flu vaccine is ready, the first people to get it should be children and young adults between age 6 months and 24 years. That strategy is expected to result in 59 million swine flu cases, 139,000 deaths and cost $67 billion.

But there is a better way, according to researchers from Yale and Clemson universities.

If vaccine doses were first distributed to children between age 5 and 19 and to adults age 30 to 39, there would be 15 million fewer infections and 31,000 fewer deaths, write mathematician Jan Medlock and epidemiologist Alison Galvani in Friday's edition of the journal Science. Their strategy would also save $14 billion, they calculate.

In their mathematical model, Medlock and Galvani assume H1N1 will be deadlier than the 1957 flu pandemic but tamer than the 1918 pandemic. They also assumed that each person infected with H1N1 will spread the virus to 1.4 additional people (if they are unvaccinated), as has been previously estimated.

To gauge how H1N1 will spread, they examined patterns in 97,904 personal interactions recorded by 7,290 people in a single day. That data led them to conclude that the strongest mixing occurs among people of similar ages, followed by mixing between school-age children and people in their parents’ age group. And children are known to be “responsible for a disproportionate amount of influenza transmission,” they write in their study.

All of that led Medlock and Galvani to conclude that the most important groups to immunize are 5- to 19-year-olds and their parents, typically between the ages of 30 and 39. This “optimal” vaccination strategy would require 62 million to 63 million doses of vaccine.

U.S. health officials have said 45 million doses will be ready by Oct. 15, with an additional 20 million doses coming online each week after that. It is not yet clear whether people will need one or two doses to get full protection.

The CDC will study the paper, but spokesman Tom Skinner told Nature News that he didn’t expect the public health agency to rethink its strategy.

“Our immunization recommendations really are not based on one single model,” he told Nature. “Models are based on many assumptions. They can be a helpful tool for identifying possibilities, but it’s really not possible to know how any specific model might play out.”

-- Karen Kaplan

[Eliza]

Swine flu: Who will get vaccinated first?

8/22/09

By Marlowe Hood (AFP)

PARIS — Governments bracing for a second, possibly more lethal, wave of swine flu are all grappling with the same unforgiving dilemma: with not enough vaccine to go around, who is going to get jabbed first?

Any lingering hopes that pharmaceutical companies could rapidly fill orders for more than a billion doses from northern hemisphere countries alone were quashed this week by the World Health Organisation (WHO).

"We need to gather advice on priority groups for initial protection," WHO head Margaret Chan said Friday.

"This is one of the most difficult decisions governments around the world will need to make, especially as we know that supplies will be extremely limited for some months to come."

But national leaders looking for guidance from international health authorities on how to best distribute vaccines that will not be available in most cases before early October, at best, are bound to be disappointed.

The European Union has yet to issue any guidelines specific to the new strain of A(H1N1) influenza that has swept across the globe, infecting hundreds of thousands and claiming at least 1,800 lives.

The WHO does suggest that health care workers should be given priority, a policy embraced by most states, but stops short of making further recommendations.

"Individual countries have to look at their own conditions and adapt," WHO spokesman Melinda Henry told AFP from Geneva.

"They have to decide whether they want to stop transmission, protect essential infrastructure, or reduce illness and death."

The problem is that these strategies each target a different segment of society, which means -- in a context of shortage -- that there simply won't be enough vaccine to protect everyone during the first critical months.

And that's not all: there is also disagreement among epidemiologists, who study how infections spread, as to which approach would save the most lives.

Researchers writing this week in the journal Science argue that the best way to halt the spread of the virus for pandemic flu is to vaccinate school age children and their parents first.

The study makes projections for the United States, but the model could be applicable in other developed nations, and perhaps across the board.

In Japan, the systematic vaccination of school children prevented more than 40,000 deaths across all age groups every year from the 1960s until the policy was dropped in 1994, according to an earlier study in the New England Journal of Medicine.

This strategy, however, is sharply at odds not only with the one adopted by most countries for fighting seasonal flu, but the one taking shape for the 2009 pandemic as well: prioritising what have long been identified as high-risk groups.

These usually include very young children older than six months, pregnant women, persons with chronic lung conditions, and the very elderly.

But pandemics don't behave like seasonal flu outbreaks, and don't always attack the same targets, experts say.

"The shift in mortality toward younger age groups was the most striking characteristic of the 20th-century pandemics," notes Mark Miller, a researcher at the Fogarty International Center, part of the US National Institutes of Health.

Early indications suggest the current pandemic -- while far less deadly than earlier ones, at least so far -- fits this pattern.

"With this virus the severe outcomes happen to people between 20 and 50 a lot of the time, which is very uncharacteristic of (seasonal) influenza," said Lone Simonsen, an epidemiologist at George Washington University and one of the architects of the US Influenza Genome Sequencing Project.

"There are some unusual risk factors too, such as severe obesity," she told AFP. Pregnant women seem to be at greater risk in all cases, she added.

And data from Mexico, the epicentre of the pandemic, shows that persons born before 1957 seems to have in-built immunity to the new strain, which could mean that the elderly, as a group, are less rather than more vulnerable.

Even tallying up potential lives lost is not a straight-forward process.

Are the deaths of a small child and a septuagenarian simply two lives lost, or does the child's weigh more heavily because of the greater number of "life years lost"?

"Which strategy countries choose is ultimately a political and ethical decision," the European Centre for Disease Prevention and Control said in a statement last year, before the current pandemic struck.

[Eliza]

Feds to Launch H1N1
Vaccination Campaign

Updated: Sunday, 23 Aug 2009, 11:04 PM EDT
Published : Sunday, 23 Aug 2009, 10:54 PM EDT

Doug Evans
Edited By: Leigha Baugham | myfoxatlanta.com
WASHINGTON (MyFOX ATLANTA) - The government plans to launch a major H1N1 flu vaccination campaign this fall. The goal is to vaccinate at least half the country's population.

The World Health Organization issued a warning that the spread of the H1N1 flu could speed up in the next few months. Health officials said they will only get one-third of the H1N1 vaccinations they had hoped for by mid-October.

Even before the medicine arrives, a government public relations push will encourage people to get the shot.

One concern is that the vaccines that are being made now may not be effective for everyone.

The costs involved with the massive campaign to get at least half of American vaccinated in months could go through the roof.

Close to $2 billion has already been spent to buy up to 195 million doses of the vaccine.

One of the main fears is that the H1N1 virus, which first popped up in the U.S. in April might change while it spreads, which could then make the vaccination efforts useless.

"The virus may mutate, it may be that the vaccine that they're making for delivery in November won't even work against the new mutated swine flu, the main thing to remember is that it is a relatively benign infection for most people," said Fox News medical consultant Isadora Rosenfeld.

The Centers of Disease Control announced this week that the H1N1 flu strain doesn't appear to be mutating as it makes its way through the southern hemisphere.

While clinical trials continue, health officials also say there have been no safety concerns as of yet during the test runs of the vaccine.

Vaccinations will be voluntary according to the CDC which is putting together a $4.8 million multimedia campaign to get the word out that people should get the H1N1 shot if it is available as well as a regular flu shot.

[Eliza]

Swine flu vaccine plans are up in the air

Doctors expect an onslaught of patients when serum is available

By CINDY GEORGE
HOUSTON CHRONICLE
Aug. 23, 2009, 10:28PM

Even though school resumes across Texas this week, plans to dole out the H1N1 vaccine to guard against inevitable back-to-school swine flu outbreaks continue to be hammered out.

The vaccine, still under development, is expected to be available by mid-October, federal health officials said during a recent media briefing.

The government will provide the serum, syringes and associated supplies for the vaccine, but hasn't detailed how providers who inject the shots will be paid.

Local health departments won't be allowed to turn away people who can't afford the administration fee for their H1N1 flu shots. Medicare and Medicaid patients will be covered, but those with private health insurance could be asked to make co-payments for an office visit.

Primary care physicians are preparing for the onslaught of vaccine seekers. Doctors affiliated with UT Physicians, the medical practice of University of Texas Medical School at Houston, for example, gave roughly 30,000 seasonal flu shots from last September through February.

This year, with the H1N1 vaccine, “we could easily approach over 100,000 injections,” said Andrew Casas, vice president and chief operating officer.

UT Physicians has already decided that insurance co-payments won't be required for established patients to receive the H1N1 vaccine.

“They're our patients,” Casas said. “We want them to be protected.”

After the H1N1 virus was identified in April, widespread illness in several Houston-area schools cut the academic year short for some students. Unlike seasonal flu that appears in late fall and tapers off with spring warmth, H1N1 virus — the swine flu — continued to circulate this summer.

The international pandemic flu has taken its toll on children and largely spared seniors, the population hardest hit by seasonal flu.


14 children have died
According to the state health department, at least 14 Texas children have died from flu-related complications in the last year. Most, if not all, had underlying health problems. A 14-year-old who died earlier this month had a staph infection and tested positive for H1N1.

That's why children, pregnant women and others at high risk of infection and severe disease are first in line for H1N1 shots.

Some states have decided to use school nurses to vaccinate students. But health officials in local school districts, including HISD, Alief, Katy, Pasadena and Cypress-Fairbanks, said there are no current plans for mass student vaccinations.

“What our role is going to be ... has not been defined,” said Evelyn Henry, HISD's director of health and medical services. “Some of that depends on when the vaccine is released and if it's going to be a one-dose regimen.”

Scientists are still determining whether the H1N1 vaccine will require one shot or two separate doses, officials said.

Double doses
Experts say parents shouldn't wait for the H1N1 vaccine to get their children vaccinated against seasonal flu as soon as possible. That vaccine should be available next month.

Children under 9 who have never had a seasonal flu vaccine should have two doses, experts said.

“Some children may need to get up to four vaccines to cover them this flu season,” said Dr. Jason Terk, a member of the Texas Medical Association's Council on Public Health.

And there's an extra wrinkle: There hasn't been any specific guidance about whether seasonal flu and H1N1 shots can be given at the same time or if the H1N1 can be administered with other routine vaccinations.

“We're going to have to provide the seasonal as soon in the season as we can, so we can get the process done,” Terk said. “The vaccine manufacturers are going to stop providing the seasonal influenza vaccine in the middle of October and shift all of their production to H1N1 — and that will make any opportunity to order any more seasonal vaccine null.”

cindy.george@chron.com

[Eliza]

Posted on Sun, Aug. 23, 2009 10:52 PM
Swine flu shots on track so far

By ALAN BAVLEY
The Kansas City Star

Everything so far is on schedule to begin delivering swine flu shots to the public by October.

Government officials already are working with manufacturers to package the vaccine in vials — the “fill and finish” stage — for distribution to doctors and clinics and hospitals.

About 50 million vaccine doses should be ready by mid-October, officials are saying.

Swine flu vaccine tests started on adults about two weeks ago at medical centers across the country, including St. Louis University. Tests on children began last week at Children’s Mercy Hospital and other locations.

Scientists are still monitoring safety data. And they don’t yet know if we’ll need one shot or two to gain enough protection against this H1N1 virus.

“It’s possible we’ll see two peaks,” one of swine flu and one of seasonal flu, said Norman Edelman, chief medical officer of the American Lung Association.

Swine flu recently subsided in the U.S. When the new flu season starts, there could be an upsurge in cases.

Or maybe not.

And while most cases so far have been relatively mild, swine flu has put almost 8,000 people in the hospital and caused more than 500 deaths in the United States.

Here’s what we do know:

Who has top priority for the first available doses of swine flu vaccine?

The Centers for Disease Control and Prevention has adopted a list of people who should get the vaccine first when supplies are limited:

•Pregnant women.

•People who live with or care for children younger than 6 months of age.

•Health care and emergency services personnel.

•Young people 6 months to 24 years old.

•Anyone 25 to 64 who has a medical condition, such as heart disease or diabetes, that puts them at higher risk from flu.

Why are older people not included among the priority groups?

Older people usually are among the most vulnerable to flu. But this time, the young top the list.

There’s been a high swine flu infection rate among children, and children and young adults have accounted for more than half the swine flu deaths, said Jay Butler, director of the CDC’s H1N1 vaccine task force.

Older people may have some swine flu immunity from their experience with previous flu seasons.

“There’s no level of immunity among children,” Butler said.

And as children come in close contact at school, we run the risk of amplifying the spread of the virus, said Sharon Frey, a physician who is leading one of the vaccine studies at St. Louis University.

“The older people are doing better (with swine flu) than the younger people. The younger people are at greater risk,” Frey said.

“The children haven’t seen it, so they’ll be infected by it, and they spread it among themselves and then to their parents.”

Is the swine flu vaccine safe?

The preliminary evidence looks promising.

“There are no red flags regarding safety,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

The first couple of weeks of testing on adults has not turned up any side effects, other than occasional pain and swelling where the vaccine is injected into the arm.

The same things can happen with regular seasonal flu vaccine.

After reviewing the initial findings from the first week of tests on adults, a federal safety panel cleared the way for tests to begin on children.

If I get the swine flu vaccine, will I be protected against regular seasonal flu?

[Eliza]

Asia way short of vaccine to fight swine flu: WHO

Tue Aug 25, 2009 8:26am EDT
By Tan Ee Lyn

HONG KONG (Reuters) - Asia is going to be way short of the new H1N1 vaccine to fight swine flu when the next surge of infections hits during the cold season this year, a spokesman for the World Health Organization said on Tuesday.

Australia and China are due to begin producing the vaccines in September, but these would be used domestically and the rest of the region is unlikely to benefit.

"Nowhere is ready ... there is going to be massive underproduction of vaccines as compared to the needs and demand," said Manila-based WHO spokesman Peter Cordingley.

Although the virus causes mild symptoms in many people, experts have warned against complacency because severe complications and deaths have occurred to pregnant women, young children, people with underlying health problems like obesity and diabetes, and worryingly, even healthy young adults.

The H1N1 is largely treatable using oseltamivir but vaccines are recommended as a population-wide method of prevention.

"We are going to see at least in Australia and China the start of the production of vaccines. Of course that doesn't make any difference at all to the rest of Asia because I think it is predictable that Australia and China will use their vaccines domestically," Cordingley told Reuters by telephone.

"Nobody is going to do very well, it'll be a long time before production comes up to even answering Australia's problems."

In Japan, the flu season has already arrived while its drug companies have not even started producing the new vaccine.

Cordingley said the lack of vaccines in developing countries was of particular concern.

"They don't have resources, they have populations that are at such high risk in cramped conditions in squatter villages, with no health services, no access to a doctor, lots of pregnant women, we are very worried about it."

PREPARATION PATCHY

Some governments in Asia have purchase contracts with major vaccine makers, but when these will arrive is still in question.

Japan wants to provide enough H1N1 flu vaccine to treat 53 million people, nearly half its population. But Japanese makers are expected to be able to produce enough vaccine to treat only 13-17 million people.

"The reality is that if we do not have enough, we have to bring them in from somewhere else," Chief Cabinet Secretary Takeo Kawamura said, adding that funds will need to be secured.

Indonesia, with a population of 226 million, has not signed any contract with foreign vaccine makers, said Tjandra Yoga Aditama, the health ministry's chief of disease control.

State-owned Bio Farma is one of 23 drug companies in the world approved by the United Nations to produce the new vaccine. But it is learning how to make seasonal flu vaccine before it can move on to manufacture H5N1 and H1N1 vaccines, the company said.

China plans to have enough vaccine to cover only 5 percent of its population by year-end, according to state media. Initial tests have shown the vaccine to be "safe and reliable."

Singapore, which has a contract with Australia's CSL Ltd to supply it with the new vaccine, is negotiating with other major vaccine manufacturers to diversify its supply.

"The key consideration in procuring pandemic vaccine is the safety and efficacy of the vaccine. Singapore is still studying the experiences of other countries and will stage our vaccine orders to take into account latest developments," it said.

Hong Kong invited vaccine makers to supply it with vaccines that will cover 2.5 million people, or a third of its population, but that plan fell through. It will open another tender soon.

(Additional reporting by Olivia Rondonuwu in Jakarta, Yoko Nishikawa and Yoko Kubota in Tokyo, Ben Blanchard in Beijing, Nopporn Wong-Anan in Singapore; Editing by Sanjeev Miglani)

[Eliza]

Judge denies group's flu vaccine request

8/26/09

By NEDRA PICKLER (AP) –

WASHINGTON — A judge on Wednesday denied an advocacy group's bid to prevent the government from giving pregnant women flu vaccines with a preservative that contains mercury.

Leaders of the Coalition for Mercury-Free Drugs say their effort took on a new urgency when a government advisory committee recently recommended that pregnant women be among the first people to get swine flu vaccinations when the vaccine becomes available this fall.

A small amount of the mercury-containing preservative thimerosal is in most influenza shots, including swine flu vaccines, but some are produced thimerosal-free. The coalition argued that pregnant women should only get the thimerosal-free version because of a risk that the mercury in the shot could poison a fetus and cause medical problems, including autism.

But U.S. District Judge Reggie Walton ruled against the group's request for a preliminary injunction because he said the group couldn't prove that pregnant women they represent would get vaccines containing thimerosal.

Walton said he would consider further written arguments in the next month about whether the lawsuit can continue.

Thimerosal used to be used in a number of vaccines, but manufacturers began removing the preservative from all routine child vaccines in 2001 as a precaution. But numerous large studies have shown no link between thimerosal and autism, or other health problems.

[Eliza]

H1N1 Vaccine Takes Off

August 28, 2009 - 12:46 PM | by: David Lewkowict


Atlanta based AeroClinic announced it will start offering the H1N1 flu shot to travellers at a series of concourse based kiosks at Hartsfield Jackson International Airport.

AeroClinic will have seven location set-up to offer the vaccine as soon as it becomes available. Starting September 15 the privately held company will begin offering the seasonal flu vaccine.

Dr Martin Cetron, of the Centers for Disease Control and Prevention says airports are a natural place for H1N1 to spread with thousands of inbound and outbound passengers in close proximity.

The CDC's Dr. Anne Shuchat says they are on track to have 45 million to 52 million units of the H1N1 vaccine available mid-October. Most Americans will need at lease 2 doses between 21 and 28 days apart.

[Eliza]

China set to approve 1-dose swine flu vaccines

9/02/09

(AP) – 13 minutes ago

BEIJING — China will soon approve domestically developed swine flu vaccines that manufacturers say can protect people against the virus with only one dose, an encouraging development for health officials racing to prepare for an expected spike in cases this winter.

Many health authorities are assuming two doses of vaccine are necessary while they await the results of trials by drug makers around the world to determine the appropriate dosage.

China's State Food and Drug Administration said on its Web site it will make a decision this week on approving two vaccines that completed clinical trials last month and passed reviews by panels of about 40 experts. Four other vaccines are being reviewed, it said.

The vaccine makers, Sinovac Biotech Ltd. and Hualan Biological Engineering Inc., said the clinical trials show their products are effective in single doses when used on people aged three to 60 years. More than 3,000 people participated in the trials.

Sinovac says it has the capacity to produce up to 30 million doses of swine flu vaccine in a year while Hualan said it can make 160 million doses.

Stockpiling vaccines is China's latest move in its aggressive approach to contain the spread of swine flu in the country of 1.3 billion people and relatively limited medical resources. It has quarantined travelers on suspicion of contact with infected people and ordered schools to test students' temperatures.

The Health Ministry says around 3,700 cases of swine flu have been confirmed on the mainland — none fatal.

China aims to have enough swine flu vaccine for 5 percent of the public by the end of the year, and although health officials have not released detailed vaccination plans, they have said health workers, public service workers and students are priority groups.

International health experts say swine flu has not been as severe as initially feared. At least 2,185 people have died, but most cases are mild and require no treatment. Worries remain that a rash of new infections could overwhelm hospitals and health authorities, particularly in poorer countries.

[Eliza]

www.chicagotribune.com/news/local/chi-f ... 5014.story

chicagotribune.com
H1N1 swine flu: Vaccine faces setbacks

Production issues mean fewer doses are likely to be ready in October, and younger recipients may need 2 shots

By William Mullen

Tribune reporter

September 8, 2009

As the swine flu spreads across the Chicago area this fall, doctors at Elmhurst Clinic plan to quickly notify pregnant women, children and other high-risk patients about the need for a vaccination, using the facility's new all-electronic database.

Yet questions about the vaccine's production leave them guessing about their ability to deliver the doses.

"We know the vaccine is coming, but we don't know when or in what quantities, which makes planning difficult," said Donald Lurye, a physician and CEO of the west suburban clinic.

The development of enough safe and effective vaccine is key to preparations for combating the expected proliferation of the H1N1 virus. Around the world, the health industry is busy producing and testing it while officials race in other ways to prepare the nation's hospitals, clinics and public health agencies -- not to mention public schools and college campuses that are filling up once again.

But just as the extent of the flu's eventual spread is unpredictable, it is unknown how quickly sufficient vaccine can be produced and whether millions of people may be delayed in getting it because of nagging production complications.

The vaccine has been slower to manufacture than expected, and fewer doses are likely to be ready in October. Doctors also are warning that each patient may require more than one dose. Another unknown is the public's willingness to take the vaccine, partly due to concerns about side effects and memories of a 1976 vaccine program that was abruptly halted.

Health officials are heavily promoting the inoculations. So far this year, fewer than 600 deaths have been attributed to H1N1 in the U.S., and swine flu was less lethal than feared during the southern hemisphere's recent winter months. But federal officials say that up to 40 percent of the U.S. population could develop symptoms during the coming winter flu season, and tens of thousands of deaths could result.

"This is one of those times that we should expect the worst and hope for the best," said Kenneth Alexander, a pediatric infectious disease specialist at the University of Chicago Hospitals. "We could be called alarmists, but I would rather be called an alarmist than be called a fool for being underprepared."

Ever since the 2009 H1N1 flu strain appeared in April in Mexico and quickly traveled to the U.S., scientists have been working to formulate a vaccine. Pharmaceutical companies around the globe are gearing up to mass produce it.

In the U.S. the vaccine is now undergoing testing for efficacy and safety at eight sites. The Obama administration last month urged an expedited timetable, but experts said the slow, deliberate methodology of perfecting the vaccine called for patience.

The vaccine is made by growing the live virus in millions of chicken eggs, then killing and purifying it. This strain, though, has not been growing as quickly as others. Manufacturers, who had hoped to release 100 million individual doses in October, have scaled back their initial estimate to between 45 million and 52 million.

The government's aim is to ultimately deliver 200 million or so doses throughout the flu season. The federal government is paying for production of the vaccine and will deliver it to 90,000 health-care provider sites around the country, said Melaney Arnold, spokeswoman for the Illinois Department of Public Health.

That includes just fewer than 3,000 sites in Illinois outside of Chicago, which will oversee its own distribution program. City officials have said they would be selecting "an assortment" of sites based on criteria such as "geography and types of providers."

The vaccine will be administered both in public hospitals and private clinics, Arnold said. If circumstances warrant, she said, both her department and Chicago have contingency plans for mass inoculations, probably through schools, public clinics and churches and temples.

And because the H1N1 virus is "so new and novel to us," in Alexander's words, Americans younger than 50 have no natural immunity to it and may need two inoculations, health officials said.

The second dose may come two or three weeks after the first.

"We have the possibility or even the likelihood that it will be a two-dose series for children, at least, and perhaps for others," Thomas Frieden, Centers for Disease Control and Prevention director, said last week.

The two-dose possibility raises the question of whether 200 million doses will be enough for everyone on the initial priority list. On its Web site, the CDC said it does not expect a shortage but that there is "some possibility that initially the vaccine will be available in limited quantities."

The CDC has identified five population segments that should get the vaccine first: pregnant women, parents and caregivers of infants, health-care workers, children and youths from ages 6 months to 24 years and anyone age 25 to 64 who has a medical condition that puts them at higher risk.

That totals about 159 million people. If there is not enough vaccine, the priority list may be reduced to as few as 42 million, primarily by limiting inoculations to children ages 6 months to 4 years and to children and adolescents ages 5 to 18 who have complicating medical conditions.

The list is far different than CDC's priority list for normal seasonal flu, which is particularly deadly, for example, for elderly people with underlying diseases. But swine flu appears to be far less so, probably because elderly people have built up immunities from previous exposure to viruses similar to swine flu.

The other challenge for health experts is persuading skeptical or skittish Americans to get vaccinated. They have battled concerns that the vaccine actually causes the flu, which doctors say is impossible, and they are grappling with persistent memories of 1976's troubled flu vaccine program.

That year, President Gerald Ford ordered a massive drive to inoculate as many Americans as possible after a swine flu virus affected soldiers at an Army post on the East Coast.

But the vaccination program was halted after about 500 people out of 45 million inoculated came down with Guillain-Barre syndrome, a serious nervous system disorder.

Ever since, people have cited fear of possible side effects as a reason for not wanting a flu shot, though subsequent studies have shown that the chances of side effects are minuscule -- and far less serious than the risk of flu-related death.

"You have to weigh the risks," Alexander said. "We can't be 100 percent certain about some things, like the slight chance of adverse side effects in a flu vaccine, but we are 100 percent certain that the vaccine will work to stave off the flu."

wmullen@tribune.com

[Eliza]

Swine Flu Shots in October Won’t Curb First U.S. Wave of Cases

By Elizabeth Lopatto

Sept. 10 (Bloomberg) -- Swine flu vaccinations planned to start in October will come too late to prevent the first wave of fall infections, said researchers who did a study on the best way to tame the pandemic.

If at least 70 percent of the U.S. had been vaccinated against swine flu this month, the spread of the disease could have been slowed to that of a mild seasonal flu, according to a study published today in the journal Science. If widespread vaccination starts next month, that may still blunt the impact of the swine flu pandemic this winter.

A targeted program that starts in children and reaches 70 percent of the population would be the most effective way to curb swine flu, according to the research led by Ira Longini, a professor of biostatistics at the University of Washington. Pandemic flu strains often cause more deaths and hospitalizations for several seasons after the first wave.

“There is some uncertainty when the peak will occur,” said Longini, in an e-mail today. Vaccination in October “would still be valuable for future population level protection. There could be a second winter wave.”

The study found children are especially important because during a school outbreak each child infects an average of 2.4 people, the researchers wrote.

Vaccines in Production

More than 20 manufacturers are planning to produce swine flu vaccines, and medical trials for safety and effectiveness have already started in people, the authors wrote.

Vaccines are slated to arrive in mid-October, a time health officials say could be the peak of outbreaks, and may not provide immunity until November, too late to hold off outbreaks triggered by students returning to schools.

“If the peak is in late October, the vaccinations, which will probably cover 15 percent of the population, will be too late to mitigate the first fall wave,” Longini added in a telephone interview today. About half the population will contract the swine flu virus in the first wave, so October vaccinations may still protect the other half against later waves, he said.

The median age of those with the pandemic virus has been 12 to 17 years, according to the World Health Organization in a statement on July 24 citing data from Canada, Chile, Japan, U.K. and the U.S.

45 Million Doses

The U.S. will receive 45 million vaccine doses by mid- October, and 20 million more each week after that until the full order of 195 million doses from five companies has been received, said Bill Hall, a spokesman for the U.S. Department of Health and Human Services on Aug. 19. Some cities, such as New York, will provide free swine flu vaccinations at schools, fair grounds and union halls.

Swine flu, known as H1N1, may infect 30 percent to 50 percent of the U.S. population, according to a planning scenario released Aug. 24 by outside advisers to the White House.

About 30 percent to 40 percent of the flu transmissions occur when one member of a household infects another, today’s research report said. Another 20 percent of transmission takes place in school and the rest happen in other settings, such as the workplace, according to the report.

To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net.

[Eliza]

Vical Pandemic Influenza Vaccine Demonstrates Cross-reactivity Against California,..

Thu Sep 10, 2009 6:30am EDT

Vical Pandemic Influenza Vaccine Demonstrates Cross-reactivity Against California, Texas and Mexico H1N1 Strains

SAN DIEGO, Sept. 10, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL)
announced today that the company's DNA vaccine against A/H1N1 pandemic influenza
(swine flu) has demonstrated robust immune responses in 100% of vaccinated
animals against virus strains isolated from recent outbreaks in three distinct
geographic locations -- California, Texas and Mexico.

Vical's plasmid DNA vaccine contains the H1 hemagglutinin gene sequence provided
by the U.S. Centers for Disease Control and Prevention (CDC) for the
swine-origin A/California/04/09 pandemic influenza virus, and after two doses
produced immune responses well above the accepted protection threshold in 100%
of vaccinated mice and rabbits using HI assays against the swine-origin
A/California/07/09 x-179a, A/Texas/15/09 and A/Mexico/4108/09 influenza viruses.
Hemagglutination inhibition (HI) titers were well above the protection threshold
of 40, ranging from 320 to 2,560 in mice, and from 640 to 2,560 in rabbits
against the California strain. Results against the Texas and Mexico strains were
essentially equivalent, ranging from 640 to 2,560 in both mice and rabbits.
Vical's vaccine would also be expected to provide similar robust immune
responses against other swine-origin A/H1N1 influenza virus subtypes, supporting
selection of a single A/H1N1 virus strain as the basis for the vaccine.

"Cross-reactivity is consistent with previous CDC reports that circulating
strains of swine-origin A/H1N1 pandemic influenza have remained antigenically
homogeneous," said Vijay B. Samant, President and Chief Executive Officer of
Vical, "but future viral changes are unpredictable and could be far more
substantial. The inherent speed of our DNA vaccine platform both in initial
development and manufacturing could be extremely important in addressing the
potential shortfalls of conventional vaccine approaches."

Vical has entered into a Cooperative Research and Development Agreement (CRADA)
with the U.S. Naval Medical Research Center (NMRC), a biomedical research
organization within the U.S. Navy, to develop a vaccine against H1N1 influenza.

"We are working with the U.S. Navy to secure funding to advance our H1 vaccine
into human clinical testing," added Mr. Samant. "Based on the sustained threat
from the ongoing H1N1 pandemic, we have initiated critical-path manufacturing
activities to allow initiation of a Phase 1 trial in as little as four to six
weeks after funding is secured."

About Vical

Vical researches and develops biopharmaceutical products based on its patented
DNA delivery technologies for the prevention and treatment of serious or
life-threatening diseases. Potential applications of the company's DNA delivery
technology include DNA vaccines for infectious diseases or cancer, in which the
expressed protein is an immunogen; cancer immunotherapeutics, in which the
expressed protein is an immune system stimulant; and cardiovascular therapies,
in which the expressed protein is an angiogenic growth factor. The company is
developing certain infectious disease vaccines and cancer therapeutics
internally. In addition, the company collaborates with major pharmaceutical
companies and biotechnology companies that give it access to complementary
technologies or greater resources. These strategic partnerships provide the
company with mutually beneficial opportunities to expand its product pipeline
and address significant unmet medical needs. Additional information on Vical is
available at www.vical.com.

The Vical Incorporated logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from those
projected. Forward-looking statements include statements about Vical's vaccine
technologies and their potential application in a vaccine against H1N1
influenza, potential human clinical testing of such a vaccine, the Vical/NMRC
CRADA, potential changes in circulating strains of influenza, potential
government regulatory and procurement activities, as well as the company's
focus, collaborative partners, and product candidates. Risks and uncertainties
include whether the company's technologies will be successfully applied for the
development of an H1 DNA vaccine; whether such vaccine will advance to clinical
testing quickly, if at all; whether funding will be secured to support a Phase 1
trial; whether Vical, NMRC or others will continue development of any influenza
DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA
before achievement of its objectives; whether the company's DNA vaccine
candidate will be effective in protecting humans against H1N1 or any other
strains of influenza; whether H1N1 pandemic influenza will undergo substantial
strain changes; whether Vical's pandemic influenza vaccine will advance
sufficiently to be considered for licensure during future pandemics; whether
results in animal testing will be predictive of results in human testing;
whether any product candidates will be shown to be safe and effective; the
timing, nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market any product candidates; whether
Vical or its collaborative partners will succeed in marketing any product
candidates; and additional risks set forth in the company's filings with the
Securities and Exchange Commission. These forward-looking statements represent
the company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking statements.

-0-
CONTACT: Vical Incorporated
Alan R. Engbring
(858) 646-1127
www.vical.com

[Eliza]

Sebelius: Swine flu shots may start early October

(AP) – 8 hours ago

WASHINGTON — The nation's health secretary says Americans could begin receiving swine flu vaccine shots as early as the first week of October — which is sooner than expected.

Kathleen Sebelius says the bulk of the vaccine is still scheduled for release nationwide by mid-October. But she says some early doses should begin rolling out sooner. She says the vaccine will be distributed directly to locations across the country and made available for immediate use.

Sebelius says she is confident the swine flue shots will be available soon enough to effectively target the illness. She says success of a one-shot dose for healthy adults and a 10-day immune response to the vaccine will help contain the spread of the flu.

Sebelius appeared on ABC's "This Week."

[Eliza]

www.chicagotribune.com/news/local/chi-f ... 6547.story

chicagotribune.com
Swine flu: H1N1 vaccine skepticism spreads among young parents


In some cases, wariness is fueled by distrust of drugmakers, media outlets and the federal government


By Melissa Healy

Tribune newspapers

September 15, 2009

LOS ANGELES

-- Tammy Reed, 28, the mother of a toddler, is not given to belief in conspiracy theories and is not the type to be rattled by the phrase "pandemic flu."

She is the kind of mom who gathers a good deal of her medical intelligence on government Web sites, trusts a friend who is a nurse practitioner and is raising her bright, strong-willed daughter with all the confidence of a former nanny. She's the kind of mom who thinks that, when the vaccine for H1N1 influenza becomes available for her daughter, she may just take a pass on it.

"It's a different brand of flu, but it is still the flu, and I think she's already built a pretty strong immune system," Reed says of her blond, blue-eyed 14-month-old. At the same time, the tests on the vaccine in development against H1N1 aren't even completed yet, and that, to Reed, sounds like a formula for unforeseen problems down the road.

"I'm really more concerned about the long-term effects and lifelong damage it could do to her," Reed said.

So for now, at least, she's made her peace with the prospect that her daughter, Coral, could have a few miserable days and a lifetime immunity from this novel strain of flu. She'll seek her pediatrician's opinion next month when Coral is due for a checkup, Reed said. "But I don't think it'll sway me at this point."

As the nation braces for a season of pandemic contagion, omnipresent vaccine clinics and debate over health-care reform, the myriad doubts of parents and citizens like Reed represent a new and potent strain of vaccine ambivalence.

Physicians said they are hearing young parents -- many of whom have neither seen nor suffered any of the once-common diseases of childhood -- express doubts about inoculating their children against the novel strain of influenza.

This new generation of vaccine skeptics has been forged by the persistent belief -- discredited by a welter of studies -- in a link between vaccines and autism. It is further fueled by a mix of distrust of drug manufacturers, media outlets and the federal government.

"A significant proportion of our population don't want to get it," said Mikayel Abramyan, a pediatrician in Sherman Oaks, Calif. "I don't even know whether I will advocate for it right now." Though Abramyan said he rarely lets the no-vaccine preference go unchallenged, "it's a reasonable position, and ... I understand where they're coming from."

Americans in their 20s, 30s and 40s have been largely spared the yearly deliberations over seasonal flu vaccine, either for themselves or their kids. School-age children and their parents are mostly in robust health.

Until very recently, they have been an afterthought in vaccination drives, which have focused instead on reaching the very old and very young -- populations at highest risk of complications from seasonal flu.

The new H1N1 virus has changed that. Epidemiologists have found that children, young adults and pregnant women who catch the new flu run a greater risk than the elderly of developing complications; as a result, all three groups top the list of those recommended to get H1N1 vaccine this year. Even before the strain emerged, many epidemiologists embraced the view that vaccinating schoolchildren, the most prolific spreaders of germs, may be the best way to ease the seasonal flu's hold on the entire population.

The collective doubts of this generation of parents, said experts in infectious disease control, could stymie the efforts of government officials and the medical establishment to stem the spread of a new contagion, and to ready for other infectious diseases that may emerge down the road.

"Swirling around parents this fall will be a lot of myths, misinformation and legitimate and factual communications," said Sandra Quinn, a University of Pittsburgh public health professor.

mhealy@tribune.com

[Eliza]

EU states may share scant H1N1 vaccine supplies


Tue Sep 15, 2009 11:00am EDT
* Commission encourages vaccine sharing between EU states

* Some countries may have excess supply, others short


LONDON, Sept 15 (Reuters) - European states may share scarce supplies of H1N1 swine flu vaccine under a European Commission plan, allowing for redistribution of supplies from the "haves" to the "have nots".

The realisation that one shot of pandemic vaccine, not two, is likely to suffice for most people means governments that placed early orders could have excess stocks while others face a shortage or even a complete lack of vaccine.

The European Union's executive arm said it would encourage "a common approach to cross-border sharing and voluntary sale within the EU".

Some countries have already included a provision in contracts with manufacturers stating that unused vaccines can be sold to other countries, it added.

"We need to remain vigilant and continue to coordinate our preparations to respond to the pandemic in the months ahead," EU Health Commissioner Androulla Vassiliou said in a statement.

The Commission also proposed an eventual joint procurement mechanism for countries ordering vaccines, since this could lead to economies of scale, although initially the aim will be to bundle together calls for national tenders.

The new H1N1 strain of flu, declared a pandemic on June 11, could eventually infect 2 billion people, according to World Health Organisation estimates.

But manufacturing capacity constraints mean there will only enough vaccine to protect a fraction of those at risk this year.

Still, a few countries that booked early could have a surplus. Britain, for example, ordered enough vaccine to give two doses to its population.

"There is a certain amount of discontent amongst other EU governments about the success of the UK government in locking up the initial supplies through its advance purchase agreements," Robert Dingwall of the University of Nottingham told reporters on Monday.