Swine Flu News

[torinsmom]

We started school August 25 and so far, we have had 4 kids out with flu like illness, not counting one who was sent home Friday and another who went home looking like death warmed over that afternoon. This is in a class of 20 kids. Only one was tested that we know of and she did have H1N1. So far, it seems to be mild in our class, taking 2-3 days for the kids to feel well. Some cases started with a bad headache and fever, while some started with the kids feeling lethargic and dizzy. I am kind of hoping that some of our kids get it out of the way during this long weekend(Is that terrible? At least parents won't miss work). We have been washing tables with clorox wipes and spraying all the work with lysol every afternoon. Hand sanitizer is required to enter the classroom(I squirt them), and anytime we hear a cough or sneeze, we send the offending child to the sink to wash hands.

I hope this passes quickly at our school. We only have 250 kids. I am so scared of getting this stuff. I don't do sick well.

Marsha

 

[Pennykay]

Swine flu worse than seasonal infection
More healthy people being struck down
Ella Lee
Sep 05, 2009

Swine flu is more dangerous than seasonal flu because about 30 per cent of those who develop severe complications have had no underlying diseases, a leading microbiologist said yesterday.

University of Hong Kong microbiology department head Professor Yuen Kwok-yung said he believed that swine flu would cause more deaths in the city as it spread in the community.

Meanwhile, the Hospital Authority plans to tighten admission criteria for children to relieve pressure on public hospitals.

Hong Kong reported 370 new swine flu cases yesterday, involving people aged between six months and 76 years. This brings the total to 13,318.

The (A)H1N1 virus has killed 10 people in Hong Kong so far.

A total of 125 people are being treated in public hospitals, with 107 in stable condition, nine serious and nine critical.

Yuen's team has analysed data relating to 22 serious cases, including four people who died. The study found that 29 per cent of those patients had a clean bill of health before they contracted swine flu.

"Swine flu is more dangerous than seasonal flu. While seasonal flu usually kills only those with chronic diseases, swine flu can strike healthy people and causes very severe complications," Yuen said.

"The new virus can cause much more serious infections in the lower respiratory tracts."

The study showed that many of the patients who became seriously ill had a low fever in the early stages of infection. The median time between the onset of illness and when the patients sought treatment at hospital was about five days. Their conditions deteriorated rapidly and they were place on ventilators a median of seven days after manifesting symptoms. The four patients who died did so a median of 10 days after the onset of infection.

"When those patients suffered breathing difficulties, their lungs were already severely damaged and Tamiflu was no longer effective on them," Yuen said.

He advised doctors to use Tamiflu more promptly, especially for high-risk patients including young children, elderly people and those with chronic diseases.

He said public awareness about swine flu had gradually dropped since the outbreak began in May. "Many people have dropped their guard and are treating swine flu as seasonal flu. That is wrong," he said.

The Hospital Authority, facing an increasing number of patients, is considering new treatment protocols. Apart from limiting laboratory tests to inpatients and those who do not respond well to antiviral treatment, the authority wants to tighten admission criteria for young children in a bid to make more beds available in public hospitals.

"The current admission criteria for young flu patients are rather loose," one doctor familiar with the situation said.

He said the number of severe and fatal cases would continue to rise as more people were infected.

"While there are more virus carriers in the community, the chances of high-risk people becoming infected are getting higher," he said. "Those with underlying diseases and pregnant women should avoid going to crowded places."

University of Hong Kong microbiologist Professor Ho Pak-leung called on the authority to improve communications with the public and private doctors. He said many patients seeking help at government flu clinics expected laboratory tests and to be prescribed Tamiflu.

"In fact, the authority only provides those services to high-risk patients. The misunderstanding causes conflicts between patients and frontline staff. There should be clearer messages to the public on what they should do and where to turn to if they get flu symptoms," Ho said.

According to the Centre for Health Protection, 16 schools reported swine flu outbreaks yesterday. Five schools have closed because of swine flu, including the Sha Tin Junior School, which closed yesterday.

Undersecretary for Food and Health Gabriel Leung said yesterday that the mortality rate for swine flu in Hong Kong was lower than in other countries. The number of schools that had closed was within government expectations.

 

[Tinijocaro]

This is good news for those who are planning to get the swine flu vaccine. I also think that the fact that many, many people will not get the shot also increases supply considerably for those who want it.


Swine Flu Shots Require Just One Dose in Study, Doubling Supply
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By Tom Randall

Sept. 10 (Bloomberg) -- One dose of swine flu vaccine was enough to protect most people from contracting the pandemic virus, according to a study that may double the anticipated stockpiles and help people get immunized faster.

A two-dose vaccine, administered three weeks apart, was widely anticipated to be necessary by scientists at the U.S. Centers for Disease Control and Prevention in Atlanta and the World Health Organization in Geneva. Today’s results suggest one dose of the formula used by drugmakers including Paris-based Sanofi Aventis SA and London-based GlaxoSmithKline Plc should offer swine-flu protection similar to the seasonal flu shot.

Twenty-one days after a first shot was given, about 95 percent of the 240 patients had achieved levels of protective antibodies sufficient to fight off the disease, according to the study published online today in the New England Journal of Medicine. The study was conducted by Melbourne, Australia-based CSL Ltd., which makes 19 percent of the U.S. stockpile and Australia’s sole supplier of pandemic vaccine.

“I’ve heard it referred to as jaw-dropping,” said Paul Perreault, president of CSL Biotherapies, CSL’s vaccine unit. “It’s pretty similar to the seasonal vaccine, which is very good news. There’s enough data here to indicate that it’s probably going to be one dose.”

CSL has agreed to provide 21 million doses to Australia and 36 million doses to the U.S., Perreault said. The U.S., which contracts with five companies, anticipates 45 million doses of its 195 million available for use by mid-October.

No Adjuvant

The vaccine in today’s study didn’t use ingredients called adjuvants included by some countries in formulations to boost effectiveness. No serious side effects were reported in the study.

Swine flu has become the world’s fastest-moving influenza pandemic, sweeping across 177 countries in the four months since it was first identified, the CDC said. More than 1 million people have already contracted the virus in New York alone, according to estimates by the city’s health department.

“In our current global situation, in which demand for influenza vaccine greatly exceeds supply, dose-sparing strategies are needed,” said Kathleen Neuzil, an infectious disease specialist at the University of Washington in Seattle, in an editorial that accompanied the journal study.

Today’s study was conducted in Australia, though U.S. regulators will use it as part of their evaluation of the vaccine, Perreault said. The U.S. National Institutes of Health is conducting separate studies.

To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

 

[MickeyMomTo2]

This is good news for those who are planning to get the swine flu vaccine. I also think that the fact that many, many people will not get the shot also increases supply considerably for those who want it.

That is great news! That also means everyone who gets the vaccine will reach immunity faster that they would with two shots!

 

[Tinijocaro]

That is great news! That also means everyone who gets the vaccine will reach immunity faster that they would with two shots!

From what I read today, it will still take two weeks for full immunity.

 

[MickeyMomTo2]

From what I read today, it will still take two weeks for full immunity.

I read 10 days, but either way, that is much faster than having to wait until after the second shot (the second shot would come 2-3 weeks after the first shot, and then you would have to wait 2 more weeks from that to reach immunity). I am just glad to hear some positive swine flu news! We are in the southeast, and it is everywhere. I worry every time I hear people coughing, when I touch shopping carts, credit card scanners, etc... I didn't used to be such a germaphobe! I know my kids wonder when I turned into the "Here, let me give you some hand sanitizer" lady. That's all they hear me say! I am excited that more people will be able to get the shot earlier and that more people will reach immunity faster. My kids will just be glad they only have to have two flu shots instead of three (seasonal plus one H1N1).

 

[Tinijocaro]

You guys are really getting hit down there. I'm in the northeast and I'm pretty sure most people don't think it is coming our way. The superintendent of my kid's and dh's school said he felt it is all overblown by the media. That makes me feel good. All it will take is one death of someone who is in your kid's district, or town to make people stand up and take notice.

 

[MickeyMomTo2]

You guys are really getting hit down there. I'm in the northeast and I'm pretty sure most people don't think it is coming our way. The superintendent of my kid's and dh's school said he felt it is all overblown by the media. That makes me feel good. All it will take is one death of someone who is in your kid's district, or town to make people stand up and take notice.

You are exactly right. A five-year-old died in the district next to ours. People started paying much more attention then. I am still amazed by people who are out and about who will say, "I have a touch of stomach flu" or "I have a really bad cold", and they don't even consider that they are spreading the flu around. Thankfully, with the exception of the little boy, I haven't heard of other serious cases in our immediate area, and there are A LOT of cases. Doctors offices and clinics are completely flooded right now.

We have been in school since Aug. 13. I know you start later in the northeast, so I would expect it to pick up there soon (although I hope it doesn't!). Of course, the northeast was hit harder in the spring when it first started than we were, so maybe that will help to keep your cases down some.

 

[MickeyMomTo2]

http://www.nhs.uk/news/2009/09September/Pages/Firstresultsfromvaccinetrial.aspx

In this clinical trial in Australia, they were surprised to find that 30% of the younger population already had some immunity to swine flu BEFORE they were vaccinated, even though a serious effort was made to only include people who had not been exposed. The article explains that this could be because many people have been exposed and they don't realize it AND/OR the 2009 seasonal vaccine offers some cross-protection. Be sure to read the results of the study further down in the article to see this info. I am getting my seasonal shot this weekend, so I hope it does offer some protection, even if it is only a little!

 

[Val]

My DS13 was one of the unlucky kids who had complications from the swine flu- he has developed an antiobiotic resistant pneumonia that kept him out of school the last 10 days. We ended up hospitalized and they pumped him full of IV antibiotics and sent him home on omnicef....he's better, but quiet weak. This kid is a long distance runnner, very physically fit, and never sick.....really, really knocked him down.

That being said, he is recovering quickly and actually ran a few laps around the track today- and he was in the hospital on Wednesday! My DD11 and DD17, as well as my DH and I had a touch of the flu, but nothing like DS.

My point is that is CAN be quite serious. We were poo-pooing all of this, but I now take this flu a little more seriously. Never know who it can strike down!

 

[MickeyMomTo2]

My DS13 was one of the unlucky kids who had complications from the swine flu- he has developed an antiobiotic resistant pneumonia that kept him out of school the last 10 days. We ended up hospitalized and they pumped him full of IV antibiotics and sent him home on omnicef....he's better, but quiet weak. This kid is a long distance runnner, very physically fit, and never sick.....really, really knocked him down.

That being said, he is recovering quickly and actually ran a few laps around the track today- and he was in the hospital on Wednesday! My DD11 and DD17, as well as my DH and I had a touch of the flu, but nothing like DS.

My point is that is CAN be quite serious. We were poo-pooing all of this, but I now take this flu a little more seriously. Never know who it can strike down!

I am so glad your son is doing better. I am sure that was a scary experience. I have asthma, so I have been taking it very seriously, but the stories of healthy people getting sick like this are truly worrisome. Glad your family is on the mend!

 

[LuvOrlando]

My poor DS has been suffering a flare up with his Asthma so we've been at the Dr's recently, as in Wednesday. I asked about the Flu shot for both of my Asthmatic kids and they are getting theirs 10/2 but when I asked about the H1N1 all I got was a shrug. No-one knows anything for certain about where I will be able to get the vaccines or when. From speaking to the office I understand The Federal Government is running this show and that they have been very secretive about what they are doing. The office told me it looks like Dr's offices have to apply to a lotto system to be able to provide the H1N1 and my office isn't doing it because its so convoluted. When I said, "So where do I go to get my high risk kids the shots will the hospital have a clinic?" I was told: "We're still not really sure, it looks like the best place will be in the schools around here." I said, "So at the schools themselves or the School District building? Who is in charge? Do I need a note from you to make sure they reserve a dose for my kids?" and they said, "It doesn't look like there is going to be way to do that. Truth is no-one really knows yet" THEN I went and called the school and the district and the people there had zero idea of what I was talking about!

SERIOUSLY, I HAVE BEEN PATIENT BUT THIS IS WEEKS AWAY AND STILL NO-ONE KNOWS ANYTHING FOR CERTAIN, WHY IS IT A SECRET? WHAT AM I SUPPOSED TO DO, WILL I BE WAITING ON LINE OUT IN THE COLD WITH 2 HIGH RISK KIDS BEHIND PANICKY PARENTS OF PERFECTLY HEALTHY KIDS WHO MAY GET THE DOSES MY KIDS NEED

Uggh, the level of incompetence here is unparalleled, on one hand you have experts sending out all these warnings on why we need the vaccine and on the other hand you have the people in charge of handing it out without any plans on how to do it. What a mess. Can I get a shout out to the powers that be to GET YOUR ACT TOGETHER!

Sebelius: Swine flu shots may start early October

Sep 13, 9:38 AM (ET)

WASHINGTON (AP) - 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."

 

[AlexWyattMommy]

There is a saying for this and it isn't family friendly.


Each state has to decide for itself HOW to distribute the shots. Our state, you have to sign up to be a site, but there is not guarantee that you will be one. I still don't know how they will do it for Ohio.

And to make it even more confusing -
http://www.commercialappeal.com/news/2009/sep/13/50-at-st-jude-work-feverishly/

St. Jude scientists trying to solve H1N1 vaccine challenges
Sunday, September 13, 2009

Outside his sixth-floor office at St. Jude Children's Research Hospital, Dr. Richard Webby steps from the crowded aisles of a laboratory into a small, out-of-the-way room containing one of the elemental ingredients in the effort to decipher and defeat the H1N1 swine flu virus -- chicken eggs, hundreds upon hundreds of them.

At St. Jude, one of the federally designated "centers of excellence" for influenza research, some 50 scientists are at work trying to solve two of the main challenges posed by a virus that touched off a global pandemic whose victims so far include about 600 dead in the U.S.
Dr. Richard Webby checks incubating eggs that will be part of influenza experiments at St. Jude Children's Research Hospital.

As if to underscore the importance of their work, a White Station Middle School eighth-grader last week became Shelby County's first swine-flu fatality. The 13-year-old's funeral was Saturday.

In the maze of molecular biology labs at St. Jude, Webby and other researchers are trying to figure out why the virus -- unlike most from swine and other animals -- has spread so readily among humans.

They're also trying to find ways to accelerate a vaccine-production process for the H1N1 flu that so far has been frustratingly slow.

That's where the eggs come in.

The H1N1 vaccine now in production at about a half-dozen manufacturers in the U.S. and other countries is created when the virus seed strain is injected into eggs, where it grows before it is extracted and processed. In the people receiving it, the finished vaccine triggers the production of antibodies that fend off illness by preventing H1N1 from attaching to red blood cells.

But the H1N1 virus grows only about half as fast as many seasonal flu viruses, slowing the production process significantly. As result, the federal government expects only about 15 million individual doses -- out of a projected eventual production of some 200 million -- to be available when the first batch is released in October.

At St. Jude, researchers are trying to solve the slow-growth problem by injecting H1N1 and components of other viruses into egg after egg. With the repeated injections, they hope to create hybrids or instigate mutations that lead to faster virus growth.

Scientists, in that way, might be able to trace where the mutation occurred within the eight strands of genetic material called ribonucleic acid contained in a virus.

"If we could identify which molecular markers are responsible (for the faster growth), we could potentially introduce those into our seed strain," said Webby, associate member of the department of infectious diseases at St. Jude.

Webby acknowledges these and other efforts to accelerate growth of the seed strains have met with frustration so far.

"We don't have anything yet," he said.

The limited availability of the vaccine during next month's initial distribution means local officials "will be implementing a priority approach," said county Health Officer Dr. Kenneth S. Robinson. Higher-risk groups, including pregnant women and caregivers for children, will be among the first vaccinated.

St. Jude was selected by the National Institutes of Health to play a critical role in the H1N1 research because the hospital "established what is probably the best known laboratory in the world for avian influenza," said Dr. Michael Shaw, associate director of laboratory science in the influenza department at the Centers for Disease Control and Prevention in Atlanta.

Using a process known as reverse-genetics, St. Jude researchers in 2003 developed a vaccine for the H5N1 avian flu virus. Although the vaccine for H1N1 came from a New York lab, St. Jude is one of the focal points of genetic research into the virus, Shaw said.

The slow growth is just one of the mysteries surrounding H1N1.

"We don't understand why some grow more slowly," Shaw said.

If successful, the St. Jude work could speed up vaccine production beginning next flu season. That could result in lower costs, allowing even the poorest nations to receive the vaccine, Shaw said.

The problem with H1N1 lies in its exotic origins and unique mix of genes.

Scientists say H1N1 was the product of a "triple reassortment" of genes from humans, birds and swine. Pigs served as the "mixing vessel" for the virus.

"We've never seen this particular blend of virus genes before," Webby said.

Six of the eight gene-carrying RNA in the H1N1 virus have been circulating in North American pigs for more than a decade. The other two were introduced recently from Eurasian swine. That's a reversal of the usual route of viruses, which normally follow the export of breeding-stock swine from the U.S. to other continents.

"That was a big surprise," Shaw said.

Most animal-borne flu viruses have "dead-end" transmission routes, meaning no more than a few people directly exposed to the animals get sick before the virus dies out.

Researchers aren't sure why H1N1 has spread so well in humans. Not only does it readily move from person to person, it is able to penetrate more deeply into the lungs than most viruses, creating a secondary risk of pneumonia, Shaw said.

The virus hasn't been as virulent in the U.S. as some health officials initially feared. But Shaw said that may reflect the fact that older, more frail people have largely been spared infection.

"You have to bear in mind, it's mainly hitting children and young adults, which generally are the healthiest members of our population," he said.

Fatalities mostly have occurred among people with underlying health problems, such as immune deficiencies and heart or respiratory problems.

"If it hits a child with asthma, it's very bad news," Shaw said. "It can cause very severe symptoms very quickly."

Shaw speculates that sometime earlier in their lives older people were exposed to a virus that gave them a degree of immunity from H1N1.

At St. Jude, Webby and other scientists are conducting genetic research on H1N1 to identify the components that make it such a threat. Then they'll be able to look for those same genes in other animal-borne flu viruses.

"When you look at these influenza viruses, there's an unlimited diversity," Webby said. "The problem is, we don't know which of these viruses poses any threat to humans -- which can get into humans and be successful."

Identifying them, he said, could enable the government to get a head start on vaccine production and stockpiling -- an advantage clearly missing in the fight against H1N1.
---------------
So from 45-50 million to 15 million being available at first. I am so hoping it was a misprint.

 

[C.Ann]

My poor DS has been suffering a flare up with his Asthma so we've been at the Dr's recently, as in Wednesday. I asked about the Flu shot for both of my Asthmatic kids and they are getting theirs 10/2 but when I asked about the H1N1 all I got was a shrug. No-one knows anything for certain about where I will be able to get the vaccines or when. From speaking to the office I understand The Federal Government is running this show and that they have been very secretive about what they are doing. The office told me it looks like Dr's offices have to apply to a lotto system to be able to provide the H1N1 and my office isn't doing it because its so convoluted. When I said, "So where do I go to get my high risk kids the shots will the hospital have a clinic?" I was told: "We're still not really sure, it looks like the best place will be in the schools around here." I said, "So at the schools themselves or the School District building? Who is in charge? Do I need a note from you to make sure they reserve a dose for my kids?" and they said, "It doesn't look like there is going to be way to do that. Truth is no-one really knows yet" THEN I went and called the school and the district and the people there had zero idea of what I was talking about!

SERIOUSLY, I HAVE BEEN PATIENT BUT THIS IS WEEKS AWAY AND STILL NO-ONE KNOWS ANYTHING FOR CERTAIN, WHY IS IT A SECRET? WHAT AM I SUPPOSED TO DO, WILL I BE WAITING ON LINE OUT IN THE COLD WITH 2 HIGH RISK KIDS BEHIND PANICKY PARENTS OF PERFECTLY HEALTHY KIDS WHO MAY GET THE DOSES MY KIDS NEED

Uggh, the level of incompetence here is unparalleled, on one hand you have experts sending out all these warnings on why we need the vaccine and on the other hand you have the people in charge of handing it out without any plans on how to do it. What a mess. Can I get a shout out to the powers that be to GET YOUR ACT TOGETHER!

Sebelius: Swine flu shots may start early October

Sep 13, 9:38 AM (ET)

WASHINGTON (AP) - 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."

Didn't I read somewhere that FEMA was to be in charge of the distribution of this vaccine - as well as determining "who" would receive it and "when"?

If so, I'm not the least bit surprised that no one knows what's going on.. FEMA doesn't exactly have a stellar reputation for the left hand knowing what the right hand is doing..

Our schools in the northeast have just opened last week and we're all holding our breath now to see if the predicted outbreaks will occur soon..

 

[honugirl]

I got my yearly flu shot last Friday at our local pharmacy and I asked if they were going to get the H1N1 shots after the nurse (gotta love small town pharmacies!) told me that the regular shot wouldn't protect me from it. Her response was that they didn't know if they were going to get any vaccine, she had no idea when or where I could get it and to call the local health department.

 

[JessicaR]

CDC Novel H1N1 Vaccination Planning Q&A
September 2, 2009, 11:45 AM ET

Vaccine Distribution
Q. When will the decision to administer vaccine be made?
A. For planning purposes, it should be assumed that vaccine will be administered beginning in the fall.

Q. When will vaccine shipping begin?
A. Planners should assume shipping of vaccine will begin mid-October, although there is a possibility that some vaccine will be available for shipping starting late September.

Q. How many manufacturers are producing vaccine?
A. Five manufacturers are producing vaccine for the U.S.: Sanofi Pasteur, Novartis, GSK, Medimmune and CSL.

Q. How will vaccine be shipped to projects areas (CDC Public Health Emergency Preparedness grantees)?
A. Vaccine will be shipped to clinics, offices, health departments, and other project area-designated sites which may include a mix of public health and private sector sites via centralized distribution. This is the same process that is used to ship vaccines for the childhood immunization program to immunization providers. CDC's centralized distribution mechanism will be substantially enhanced to provide capacity for this activity in addition to shipping of other vaccines.

Q. Will project areas (CDC Public Health Emergency Preparedness grantees) be able to limit the amount of vaccine they receive?
A. Yes, project areas will be able to determine what proportion of their allocation they wish to receive.

Q. How frequently will vaccine shipments arrive?
A. As details of distribution are finalized, CDC will communicate with states about the anticipated time period between placing vaccine orders and receiving shipments.

Q. How many sites can be designated as vaccine receiving sites?
A.One of the key benefits of using a centralized, third party distributor to support H1N1 vaccine distribution is that it allows distribution of doses to a much larger number of providers sites than would be feasible with direct manufacturer distribution. Thus, we will be able to serve a significantly larger provider base than the original state ship to sites, and are planning to be able to accommodate more providers than are currently served by the VFC program. More information, including any limitations in the number of vaccine receiving sites, will be shared with state planners as soon as it becomes available.

Q. Will vaccine be in multi-dose vials?
A. The majority of vaccine will be in multi-dose vials, the remainder in single dose syringes or nasal sprayers. The aim is to have enough vaccine in single dose syringes (i.e. preservative free) for young children and pregnant women.

Vaccine Purchase
Q. How will novel H1N1 vaccine be purchased?
A. Novel H1N1 vaccine will be procured and purchased by the federal government and made available for vaccinators at no cost. See section below titled “Vaccine administration fees” for information on cost of administration.

Vaccine administration fees
Q. Will insurance plans reimburse private providers for administration?
A. CDC asked America's Health Insurance Plans (AHIP) and on behalf of its members, AHIP provided this response:
"Every year health plans contribute to the seasonal flu vaccination campaign in several ways:

a) Health plans communicate directly with plan sponsors and members on the current ACIP recommendations and encourage immunization; they also provide information on where to get vaccinations, and who to contact with any questions.

b) Just as health plans have provided extensive coverage for the administration of seasonal flu vaccines in the past, public health planners can make the assumption that health plans will provide reimbursement for the administration of a novel (A) H1N1 vaccine to their members by private sector providers in both traditional settings e.g., doctor’s office, ambulatory clinics, health care facilities, and in non-traditional settings, where contracts with insurers have been established"

Q. Will private providers be able to charge patients for vaccine administration if they are uninsured?
A. Yes, providers may charge patients if they are uninsured. The administration fee cannot exceed the regional Medicare vaccine administration fee.

Q. Can persons be charged for vaccine administration in public health-organized large scale vaccination clinics?
A. There will be no administration fee for vaccination in public-health organized large scale vaccination clinics.


Vaccine Allocation
Q. How will vaccine be allocated among project areas (the CDC PHEP grantees)?
A. Vaccine will be allocated to each project area in proportion to its population (pro rata).

Q. Will there be a separate allocation for active duty DOD?
A. Yes, there will be a separate allocation for active duty DoD. It is not included in the project area allocations.

Q. Will there be a separate allocation for DoD dependants, retirees and civilian employees?
A.There is no separate allocation for these groups. Military facilities may be willing to vaccinate these groups, but will need to be allocated vaccine for these populations by the project areas.

Q. Will there be a separate vaccine allocation for IHS-served populations and other tribal communities?
A. There will be no separate allocation. States and local areas need to work with their tribal populations to ensure access to vaccine.

Ancillary Supplies
Q. Which ancillary supplies will be provided with vaccine?
A. HHS will provide needles, syringes, sharps containers and alcohol swabs.

Q. How will ancillary supplies be distributed?
A. Ancillary supplies will be distributed to the same project area-designated sites as vaccine. Plans for ensuring the distribution of these products are currently being developed.

Vaccine Administration
Q. Will two doses of vaccine be required?
A. This will not be known until the late summer- early fall, once clinical trials are completed. For planning purposes, planners should assume that two doses will be needed.

Q. What will be the recommended interval between the first and second dose?
A. This will not be known until clinical trials are complete. For planning purposes, planners should assume 21-28 days between the first and second vaccination.

Q. How much Thimerosal-free vaccine will be available?
A. It is anticipated that enough thimerosal-free vaccine in pre-loaded syringes will be available for young children and pregnant women.

Q. Will there be federal requirements to recall persons for their second dose, if a second dose is needed?
A. There will be no federal requirement to send out recall notices. Providing information on second dose at the time of the first dose, as well as using the media to disseminate this message will be the primary means of educating persons about who needs a second dose administered.

Q. Will it be necessary for the first and second dose to be the same product?
A. Ideally, first and second doses would be from the same product. However, practical considerations make this difficult to implement. Planners should assume they will be interchangeable.

Q. Can seasonal vaccine and novel H1N1 vaccine be administered at the same time?
A. Clinical trials are exploring this question. It is anticipated that seasonal vaccine and novel H1N1 vaccines may be administered together.

Q. Will vaccine be adjuvanted?
A. It is unlikely H1N1 vaccine will be adjuvanted. Definitive information will be available once clinical trial data are available.

Q. If vaccine is adjuvanted, how will it be formulated?
A. Formulation will vary by provider. For Novartis, vaccine may be preformulated with adjuvant. For CSL, GSK and Sanofi Pasteur, mixing of vaccine and adjuvant at the site of administration will be necessary. Specific information on storage requirements and procedures for mixing vaccine and adjuvant will be provided by CDC. Medimmune vaccine will not be adjuvanted.

Q. Will the vaccine be administered under EUA (Emergency Use Authorization)?
A. EUA will not be used for unadjuvanted vaccine if FDA licenses the vaccine under the current BLA (Biologics License Application) as a strain change.

Q. For whom will novel H1N1 vaccine be recommended?
A. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) met on July 29th to develop recommendations on who should receive the novel 2009-H1N1 vaccine when it becomes available, and to determine which groups of the population should be prioritized if the vaccine is initially available in extremely limited quantities. The committee recommended that vaccination efforts initially focus on 5 target groups: vaccination for pregnant women, people who live with or care for children younger than 6 months of age, healthcare and emergency medical services personnel, persons between the ages of 6 months through 24 years, and people ages 25 through 64 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems. We do not expect that there will be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities. So, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the CDC press release CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1. Once the demand for vaccine for the prioritized groups has been met at the local level, programs and providers should also begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons age 65 or older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older. (see http://www.cdc.gov/h1n1flu/vaccination/acip.htm)

Q. Will there be flexibility in how states implement the recommendations?
A. The ACIP recommendations leave room for flexibility at the local level depending on the local vaccine supply situation.

Q. Given the potential for large amounts of vaccine available during the first month of vaccine shipments, are priority groups needed?
A. It is not expected that there will be a shortage of novel H1N1 vaccine, but availability and demand can be unpredictable, and there is some possibility that initially the vaccine will be available in limited quantities and priority groups may be needed.

Q. Will there be requirements regarding documentation of priority group membership?
A. There will be no federal requirements for vaccinators to require documentation of priority group status such as a doctor’s note documenting pregnancy or risk status.

http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm

 

[JessicaR]

LA Times 09/14/09
Questions remain in H1N1 vaccine distribution

As the United States gears up for one of the largest vaccination programs ever conducted, the broad outlines of the campaign to vaccinate nearly 100 million Americans against pandemic H1N1 influenza virus by Christmas are beginning to fall into place.

Many key questions remain, however, including precisely when the vaccines will become available and exactly where the public will be able to get shots. The situation is further complicated by the need to vaccinate about the same number of people against seasonal flu during roughly the same period. One key question was cleared up Friday when it became apparent that only one dose of the swine flu vaccine will be required.

The seasonal flu vaccination effort will be handled as usual, but the "unprecedented" effort against H1N1 is "very complicated logistically," said Dr. Jonathan Fielding, Los Angeles County's health officer. The only reason it is possible at all, he added, is because the 2003 outbreak of severe acute respiratory syndrome, or SARS, and the subsequent fears of an avian flu pandemic led public health officials to prepare plans for a mass vaccination program such as that now being undertaken.

The key difference between the current H1N1 campaign and past immunization programs is that the federal government is paying for the vaccine this time, rather than sticking the consumer and local health departments with the bill. The U.S. Department of Health and Human Services has ordered the ingredients for 195 million doses of vaccine against the virus, commonly known as swine flu.

The government has also ordered corresponding quantities of syringes, needles, sharps disposal containers, alcohol swabs and other paraphernalia required for swine flu immunization. All "will be provided at no cost to those who will vaccinate," said Dr. Pascale Wortley, chief of the Centers for Disease Control and Prevention's health service research and evaluation section.

Who will vaccinate? Most everyone who normally provides seasonal flu shots, and a lot of other people as well.

The distribution chain for the vaccine is like a massive pyramid, with the CDC at the top and pharmacies, physicians, clinics, hospitals, schools and others below.

Those people and institutions will place their orders for vaccine with county and state health departments, which will triage the requests to make sure the vaccine is allocated fairly and to ensure that the most crucial vaccine targets receive it first. Those targets include pregnant women; healthcare providers; caretakers of young children; children and young people between the ages of 6 months and 24 years; and non-elderly adults with underlying medical conditions, such as heart problems and diabetes. Healthy adults will be able to get it after the target groups needs are met.

The high-priority group totals 159 million people. But no one expects all of them to show up for shots. In a normal flu season, about half those eligible for vaccination receive it, and that percentage is likely to be considerably smaller for the vaccination against the new flu strain because of unsubstantiated concerns about the safety and testing of the vaccine.

If there proves to be a shortage of the vaccine, the CDC has a priority list of about 40 million people who should go to the head of the line -- pregnant women; parents and caretakers of children younger than 6; healthcare workers with direct exposure to infected patients or to the virus; children between 6 months and 4 years of age; and those ages 5 to 18 with underlying risk factors.

Most hospitals in the area are providing the vaccine free to employees and strongly encouraging them to get it. Vaccination is typically voluntary, but UC Irvine Medical Center is mandating it for all employees, said media relations director Cathy Lawhon. Past experience at most hospitals indicates that 50% to 70% of employees receive flu vaccines. Those who don't must, by state law, sign a letter of declination.

Colleges and universities will offer the vaccine to students and, in many cases, to faculty as well, either free or for a nominal charge of perhaps $10 to $15 to cover administrative costs.

Most elementary and high schools will not offer the vaccines, however. "Schools have told us that it is too logistically complicated to send a permission slip home and have it returned," Fielding said. Some schools may serve as vaccination sites, but only as part of a broader community program. Orange County has not yet determined whether it will run school programs, said county health director Dr. Nancy Bowen.

Other vaccination sites in Los Angeles County may include fairgrounds, civic centers, community centers and other facilities that can handle a high traffic flow, provide security and have sufficient parking. They should also be near bus stops or Metro stations, Fielding said. At most sites, the vaccines will be free, but pharmacies and physicians will most likely charge a small fee for administration of the vaccine.

To administer the shots, the health department will mobilize all of its employees, each of whom has been trained as a first responder and can give vaccinations. The county also has a reserve group of physicians and nurses that it can call on, and it will enlist students at nursing schools and other county agencies. Moreover, it will need help from the police to help secure the facilities and from other agencies to help coordinate logistics, he said.

http://www.latimes.com/features/health/la-he-vaccines14-2009sep14,0,7766715.story

 

[LuvOrlando]

Thanks for that JessicaR, it is very nice of you to pass this on.

But, and this is a criticism of the people who put this out not of JessicaR for providing it, my biggest questions are still not answered in all those words.

Who exactly will offer this vaccine where I am and how will I find them?
Will there be a website where I can pop in my zip code to find locations? Will there be appointments or will it be first come first serve?

How exactly do they plan on designating the first priority recipients from the general public? Do I need to ask my Dr for a note or is this an honor system? The authorities can say whatever they want but if there is no way to check into authenticity of people' claims anyone could claim to be in one of the groups and lie about pregnancy or caring for a child under 6 months for example.

When will all of this be finalized?
At the moment everything is so vague it could mean anything and so it means absolutely nothing.

For goodness sake, this has so many holes in it it's a wonder they bothered to release anything at all. I want dates, locations, names of who is in charge, a phone number and website as streamlined and as centralized as this program is supposed to be, and I want it soon. This is supposed to roll out in a few weeks which SHOULD mean everything is in place and we are just waiting for shipments... I mean if this is as logistically troubling as everyone seems to expect shouldn't everything already be in place? Sure they can't send the vaccine yet, but shouldn't the needles and other supplies be making their way to their destinations already so sites don't end up with vaccines in hand but no means to distribute it because of shipping delays? Also, shouldn't all the people expected to administer these shots already be hired and know both when and where they are supposed to report to do their jobs? Uggh, the distinct possibility that this will be messed up is very troubling to me.

 

[jrmasm]

Thanks for that JessicaR, it is very nice of you to pass this on.

But, and this is a criticism of the people who put this out not of JessicaR for providing it, my biggest questions are still not answered in all those words.

Who exactly will offer this vaccine where I am and how will I find them?
Will there be a website where I can pop in my zip code to find locations? Will there be appointments or will it be first come first serve?

How exactly do they plan on designating the first priority recipients from the general public? Do I need to ask my Dr for a note or is this an honor system? The authorities can say whatever they want but if there is no way to check into authenticity of people' claims anyone could claim to be in one of the groups and lie about pregnancy or caring for a child under 6 months for example.

When will all of this be finalized?
At the moment everything is so vague it could mean anything and so it means absolutely nothing.

For goodness sake, this has so many holes in it it's a wonder they bothered to release anything at all. I want dates, locations, names of who is in charge, a phone number and website as streamlined and as centralized as this program is supposed to be, and I want it soon. This is supposed to roll out in a few weeks which SHOULD mean everything is in place and we are just waiting for shipments... I mean if this is as logistically troubling as everyone seems to expect shouldn't everything already be in place? Sure they can't send the vaccine yet, but shouldn't the needles and other supplies be making their way to their destinations already so sites don't end up with vaccines in hand but no means to distribute it because of shipping delays? Also, shouldn't all the people expected to administer these shots already be hired and know both when and where they are supposed to report to do their jobs? Uggh, the distinct possibility that this will be messed up is very troubling to me.

Have you tried calling your state Dept of Health? Check your local news websites? What about calling your family Dr?

 

[honugirl]

At this point in time, I am unable to get any info from our local health department. If they can't tell us, who can? I'm with LuvOrlando on this. It's too close to vaccination time for them to be unable to tell us this info.

I love that people in my high risk category are not part of the 40 million on the dedicated list in case of shortages. Brilliant. Thanks. Nice to know that high risk young adults are going to go without.