Friday, September 4, 2009

Mr Treyfish goes to Washington





I am writing this for my flu site friends so they can get a glimpse of what I saw and the interworkings of the gov't on this pandemic..I did not speak nor ask a single question. This is not an expose' and no I am not bought and sold. Only what I saw and how I feel about this meeting and the pandemic at this time..

Wheres the **** hotel? What are they gonna talk about? Who is gonna be there? I rolled around so much, I wore a hole in the sheets..sleep was only a dream away. Finally my woman couldn't take it anymore and got up... leaving more room to roll around.
We knew we would be leaving early and already it was time for me to get up. She had the directions written down and away we went to get stuck in D.C. traffic. The first 2 hrs went smoothly, then we met the big slowdown. I arrved at 8:40am, 10 mins late, gave her a kiss and ran for the front door.

Inside I went past 3 bellhops and other hotel staff, the place was bustling wth activity as I hurried past. Down the steps to the ballroom there was a table for people to get their programs, name tags and get signed in. Another area with coffee and other drinks was further down. Just as I walked in Anthony Fauci was walkin by and we shook hand and exchanged greetings. I haven't been there for 1 minute and already I was shaking hands with one of the very smartest people in the vaccine world..not bad for a long haired carpenter.

I signed in, grabbed a well needed coffee and bam, ran right into Dem from the Wikie, another smart dude. We talked about the rapid loss of pregnant woman, and I told him I remembered that at the last meeting we were at, how he told me how we have to work with who we got and try to do what we can. He was right. None of us or them have ever lived through real pandemic as this and we knew we were in uncharted waters.

Sharon finds me a moment later and we start chattin it up as the main crowd started filing in.
she tells me where my seat is and we go into he big room. Tables are set in the middle in a u shape with a podium and big screen at one end. Other chairs and tables are on the outside of them in a second ring and more at the other end of the room. 50 people sat at the ring with micrphones. Almost every other chair was filled, I sat behind Sharon and beside a man from the EPA. No microphone for me..probably a good thing.

The big hall slowly filled with the stars of the vaccine and pandemic world stage and I saw many from the last meeting I went to 2 years ago. I didn't see any falling asleep at this one.

John O Brennan, Assistsant to the President for Homeland Security and Counterterrorism got the ball rolling. A big man, you could tel he wasn't for no stuff and spoke of the seriuosness of the pandemic and being ready for the fall and any unknowns.

Next was Secretary Katheen Sebelius from HHS at the podium. She is she spoke of the many scientists and making sure the pubic gets realtime info and that all actions are directed by the best science we have. The healthcare system may be overwhelmed and that vaccines are our best option and all need the seasonal vaccine also. There may be some attempts to tie vaccine to normal deaths that occur naturally.

She is right on this also as we already know that there will be plenty of natural and abnormal deaths going on all throughout this pandemic, that will add to the total number of deaths. Some will just not be able to be saved, due to severety of injuries or already overcrowded conditions. I don't envy the drs that will have hard work and decisions cut out for them. Sebelous also said she wants the public will be provided with complete information and the last exercise led them to revamp quarintine procedure at the CDC.

The next speaker was Anne Schuchat MD,Assistant Surgeon General, US Publc Health Service Director,National Center for Immunization and respiratory Diseases.
She gave us the current update which is also no different than you already know.
There is no mutation from the south as of yet.
The vaccine is a good match.
Young people are affected worse than others.
The vaccine is voluntary.
They are sill evaluating the vaccine.


To which I add is normal also and the vaccine and later effects and the whole vaccination program will be evaluated for years to come.

The virus jumped in spring, stayed steady all summer and is now having an uptick, mainly in the southeast due to school openings.

..Here I will add I don't think keeping schools open is a good idea, at least until all the kids can be vaccinated and get an ideas as to how this pandemic is gonna play out. I am a parent of a diasabled child and am in no hurry to send him straight into the firestorm. .and don't think I will until he has been vaccinated. They will have a hard time convincing me all is good with this thing, now that his kind are at the top of the list for vaccination.
If kids can be at home for 3 month and didn't starve to death or become competely useless, I think the parents can stand them a few more months. If they are afraid the econmy will be worse off than it is now, because a parent may be at home more often to take care of the child, Imagine how bad it will get when they are in the street bitchin that their kid is dead and it's the gov't fault for keeping the schools open.
...Jus saying, other countries are delaying the start of school until that happens, and this country has the technology to teach them at home.

As pointed out before the list of people prioritized are:

HCW
Pregnant
Those that live with infants 6 month or younger
6m to 24 yrs
25 to 64 with medical conditions


Now I see that chldren with Neurological conditions should be first in line. This includes my son,which may mean my family of 4 should probably be included or what the hell give it to him for. If any of the others got sick before he had both shots, if 2 are still required, then he would get sick anyway, defeating the purpose and wasting the shot. I did not hear of any talk of this at the exercise.

Next was Bill Hall who told us from here on out we were off the record so everyone was free to speak. He ntroduced Forrest Sawyer as the moderator again as he was at the other meeting. Off the recrod, for the record, is a good idea but was unexpected I think by a lot of people, not just me. It is a way for the decision maker to realy go at it and be challenged not only by the mod, but by the tons of media peple there.

Not a compete list but from my scribbled notes..
Flutrackers
Flu Wikie
AFD
CIDRAP
Dept of Homeland Security
HHS "Health and human services"
CDC
NIAD
H1N1 Task Force
EPA
White House media
Dept of Education
Va dept of Health
Maryland dept of Health
CNN
NBC
ABC
CBS
Time MAG
REUTERS
NPR
USA Today
Newshour/with Jim Lehr
ABC Radio
There were also Drs, Data recroders, onlookers and a few other technical types and Photographers/cameramen.
The room was full.

There was quite a bit of robust discussion and it was started out by no other than DEM from Ct. He got the first question from Sawyer and the ball was rollin. The exercise had started and didn't let up for about 3 hrs, till we took a break around 11.
Since we weren't to talk aout who said what, I think in general terms I can try to give a picture of what the exercise was about.
The scenario's were more or less how certain things would be handled in the case of adverse events not in the gov'ts direct control. How would they handle a incident overeas and a whole myriad of other situations, many I had never invisioned.
I tell ya, these guys are thinking and really put or health officials to the test. To see how they handled them was a credit to strong training and quick thinking. Not everything went so smooth all the time and there were a few laughs from everyone at times and it broke the tension in the atmosphere. Serious bizz these pandemic exercises..

Breaktime..
went for a smoke and to find my lady.She was asleep in the car and payin High $$ to park. Without her taking care of me you wouldn't get very much news from me. She is as competely involved and knows as much as you do about Panflu 09.
Another kiss and not much time so I ran back downstairs and caught up with the gang and lisa frm Cidrap. She is cool as hell and we talked about the Egypt coinfection thing and she complemented FT for the work they did on translations and Sharon tell us of some news of what Egypt was doing with the pigs and then break was over..more coffee and we went back in for

round 2.

Forrest Sawyer goes back to the screen and we follow in the book. The next scenario is about who will get the vaccine and why and what order. These things are already known but they are tested by the media guys and the media is asked how they will report on certain problems that arise. Some media said they would ride the problem like a rented mule. During these times I said to myself...What?.. and take Michael Jackson off the t.v. screen! You mean you would talk about a pandemic for more than 20 seconds! If you could have seen my eyes roll when they said that!
I see the news and read the reports everyday and I know who reports what. If I saw actual realtime facts on tv...oh nevermind.
Lunchbreak and time for a smoke..

I had lunch at the table with Sharon, Mike, Maggie Fox and another guy not sure who he was and not sure if they knew who I was. Good lunch, ran for a smoke, Got a kiss and back we went for
round 3

The last part of the exercise was the wrap up and the part called a hotwash. A vaccine truck crashed and how were they gonna handle it. They really put these guys to the test and the media types were no slouches for the most part.
There were some that said very little and others that had the hard questions for the health guys and gals and Forrest Sawyer was relentless on them.
Of course none of the answers were writtin in stone, but most seemed **** good to me.
A lot of the answers to questions asked were already known to me and to you. Nothing added to any vaccines if not absolutely neccesary and all vacs are voluntary. This is an evolving situation and as much as we dont like it, or don't want to face it, we have no choice in the matter. Time to man up.

There will always be risks of problems in some cases of any vaccine use, but the benefits outweigh the risk. After all, this is a full blown pandemic and a vaccine is really all we are gonna have. At the end, everyone at the table had a chance to give a little summary on what they thought of the operation and what they liked and disliked about it, general statements and such.
EXERCISE OVER
Man was I glad..tired but glad to attend this meeting, as I think it will my last for a long time. I stand to strech out for a couple minutes and Mr. Fauci walks right by and we shake hand again real good and exchange a few words. I tell sharon good bye and thank you and that i will be home in 3 hrs and you know what I will be doing.
I head for the steps and reach for asmoke and when I get outside, I see Dr Schuchat. I shake her hand and tell her I have few ideas that may be helpful and she says great, email me and she gives me her email. She hops In a black gov't ride and I head for the Trooper and my ever faithful girl... we have a long ride home.

The pandemic is here now and I know for myself, that we won't go down without a fight.
These people are doing the very best they can under the circumstances. After Tamiflu wears it's usefulness out, what are you gonna have? You can't stay in your house and away from people forever. I can't drink cow urine. I dont have a cow.
You can kick and you can scream and say it's a lie, but scientist and vaccine makers have families too.They are not making something, they themselves don't believe, won't be helpful to mankind.
I won't apologize for any previous lack of preparedness messages and I do think they could do better in that dept. Hopefully they will start to.

Feds engage media on pandemic vaccine communication

Sep 3, 2009 (CIDRAP News) – In advance of the expected pandemic H1N1 vaccination campaign this fall, the US Department of Health and Human Services (HHS) yesterday invited the media to join federal officials in a tabletop exercise to prepare for some possible communications challenges.

About 40 members of the national press took part in the Washington, DC, event, which included some online flu blogs and news services, as well as state and local public health officials. Representatives from several federal agencies participated.

Discussions during the three exercise modules were off the record so that federal officials could freely discuss their responses to potential communications problems.

Forrest Sawyer, a former news anchor with ABC and NBC, moderated the discussion. He said the exercise was designed to "pressure test" the response to communications issues that may arise as the vaccine campaign launches and moves forward.

Yesterday's event was HHS's seventh such pandemic communications tabletop exercise with the media. Past events featured fictional scenarios that revolved around H5N1 influenza. The last one, which was the first to include online media, was held in March 2008.

Before yesterday's exercise began, HHS Secretary Kathleen Sebelius said now that many schools are back in session, parents are starting to ask when the novel H1N1 vaccine will be available.

"Leveling with the public about the need to get the shot is very important," she said, adding that one communications challenge will be explaining baseline rates of health events such as neurological conditions and miscarriage so that the public will have accurate information to assess vaccine safety concerns.

Sebelius said the tabletop exercises have been very useful in the past and, for example, prompted efforts by the Centers for Disease Control and Prevention (CDC) to further train its quarantine staff.

Many of the scenario discussions circled back to safety perceptions after the rollout of the immunization campaign. Other themes touched on the complexity of some of the pandemic flu health messages and how difficult it can be to portray risks.

After the exercise, several federal officials said the exercise was helpful. Jesse Goodman, the Food and Drug Administration's acting chief scientist and deputy commissioner for scientific and medical programs, said, "This reinforces that we can never communicate too much," The challenge is to clearly communicate complex issues, he said.

Bill Hall, news director for HHS, said, "The public wants a simple message, but nothing about flu is simple."

He said it was helpful for federal officials to see that safety topics kept cropping up during the exercise and that the risk perception discussions were productive. "If we can educate the public more on the nature of the risks, that may help us with behavior change."

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the tabletop exercise was helpful because it gave voice to the fears and risks that are staples of "real world public health." The media have to communicate the science part of the flu in that environment. "When you filet out and look at all of the uncertainties, you have a common appreciation for the difficulties we are facing," he said.

Bruce Gellin, MD, director of the National Vaccine Program at HHS, said the exercise was meaningful, not just for issues specific to the pandemic H1N1 vaccine, but for immunization issues in general.

As a frequent voice of the CDC at press conferences, congressional hearings, and public webcasts, Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, said she appreciated having the chance to spend a day mainly listening. "The more we understand your needs, the better we can respond to them," she told the media.

See also:

Mar 19, 2008, CIDRAP News story "HHS includes online services in pandemic communication drill"

CDC report sheds light on pandemic H1N1 deaths in children

Sep 3, 2009 (CIDRAP News) – Though the pandemic H1N1 virus never faded from the scene during the summer, illnesses are starting to pick up again, particularly in the southeastern states where school has already started, Thomas Frieden, MD, director of the US Centers for Disease Control and Prevention (CDC) said today.

Frieden's comments came the same day the CDC released a report on pediatric deaths from novel H1N1 infections in children, which seem to be striking those with neurodevelopmental conditions the hardest and showing a bacterial pneumonia coinfection pattern, even in previously healthy children. The report appears in the Sep 4 issue of Morbidity and Mortality Weekly Report (MMWR).

Though there's no sign that novel H1N1 is becoming more deadly, the CDC is vigorously monitoring the virus and is prepared to change its approach to fighting the virus if needed, Frieden said.

The Department of Health and Human Services (HHS) today also issued an update on the pandemic H1N1 virus activity in five southern hemisphere countries, available on the flu.gov Web site. Though patterns there resemble the experience the United States had in the spring, the assessment suggests that indigenous populations may be disproportionately affected, he said.

"This information, plus the information on children, shows who is at highest risk and who we need to reach out the most," Frieden added.

The MMWR report includes 36 pediatric deaths that occurred from April through August 8. About two-thirds of the children had at least one underlying medical condition, such as cerebral palsy, muscular dystrophy, or chronic cardiac problems, which is higher than the percentage reported during recent flu seasons. CDC investigators found that, of 23 children who had lab results reported, 10 (43%) had bacterial coinfections. (Three involved methicillin-resistant Staphylococcus aureus.)

Of 31 children for whom medication treatment is known, 19 received antivirals, but only 2 were treated within 2 days of illness onset when the drugs are known to be most effective.

Frieden said though the pneumonia findings aren't unexpected, it's important for physicians to consider prescribing antibiotics for young patients who were ill and seemed to be recovering but then come back in with a high fever.

"The take-home message is that kids with underlying conditions are first in line when the vaccine is available," he said, adding that he will have his own kids receive the vaccine when campaigns begin. "I recommend all school kids get the vaccine."

In advance of the vaccine's arrival, expected in mid October, the CDC will be making efforts to give the public more information to assess vaccine risks, Frieden said. For example, the baseline rate for miscarriages the week after women receive the seasonal flu vaccine is just over 1,000 in 500,000 who receive the shot, about the same as the rate in unvaccinated women.

Until the vaccine arrives, the CDC is also asking Americans to take extra efforts to reduce the number of illnesses and the burden on the healthcare system, he said. Staying home when sick, hand washing, and proper cough and sneeze hygiene are vital, he said.

Most people, except for those with underlying conditions, will typically recover without testing and treatment. However, those who have severe symptoms such as trouble breathing or a recurrence of fever should contact their doctors.

CDC. Surveillance for pediatric deaths associated with 2009 pandemic influenza A (H1N1) virus infection, United States, April-August 2009. MMWR 2009 Sep 4;58(34):941-7 [Full text]

Institute of Medicine IOM affirms CDC guidance on N95 use in H1N1 setting

Robert Roos News Editor

Sep 3, 2009 (CIDRAP News) – The Institute of Medicine (IOM) today affirmed existing federal guidance that healthcare workers caring for H1N1 influenza patients should wear fit-tested N95 respirators, not just surgical masks, to protect them from the virus.

At the same time, the IOM called for additional research on flu transmission and the effectiveness of various respiratory protection tools in clinical settings, along with efforts to develop new respiratory protection technologies to enhance safety and comfort.

"Based on what we currently know about influenza, well-fitted N95 respirators offer health care workers the best protection against inhalation of viral particles," said Kenneth Shine, chair of the committee that wrote the report, in an IOM news release.

"But there is a lot we still don't know about these viruses, and it would be a mistake for anyone to rely on respirators alone as some sort of magic shield," added Shine, who is executive vice chancellor for health affairs in the University of Texas System, Austin, and former president of the IOM.. "Health care organizations and their employees should establish and practice a number of strategies to guard against infection, such as innovative triage processes, hand washing, disinfection, gloves, vaccination, and antiviral drug use."

But the IOM report drew criticism today from a representative of the Association of Professionals in Infection Control and Hospital Epidemiology (APIC), who said the recommendation to wear N95s fails to recognize the many practical and logistical problems related to N95 use, including discomfort, costs, shortages, and the difficulty of fit testing.

In the face of unclear science concerning flu virus transmission, the IOM prepared the report at the request of the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA).

The panel, which was given just 8 weeks to write the report, held a 4-day meeting, including a 1 1/2-day public workshop, in August. The panel's assignment specifically excluded the economical and logistical considerations related to personal protective equipment (PPE).

The report notes that the current CDC guidance on protection for health workers caring for H1N1 patients differs from guidance from the World Health Organization (WHO) and Canadian guidance. The CDC recommends use of N95s for all healthcare workers who enter the rooms of patients in isolation with confirmed or suspected H1N1 infection. The same advice goes for emergency medical personnel who come in close contact with such patients.

In contrast, the WHO recommends "standard and droplet precautions (including a medical mask, gown, gloves, eye protection, hand hygiene) for those working in direct contact with patients and additional precautions for aerosol-generating procedures including wearing a facial particulate respirator," the report says. The recommendation allows for "the need for sustainability" in different countries.

Similarly, recently released Canadian guidelines call for using N95s only during aerosol-generating procedures and recommend using medical (surgical) masks in other situations, according to the report.

On the murky question of the extent to which flu viruses spread through the air, the IOM committee concluded that studies show that "airborne (inhalation) transmission is one of the potential routes of transmission."

-snip- [click on title for full article]

CDC study: Swine flu deaths higher in older kids

By Mike Stobbe Associated Press
Thursday, September 3, 2009

ATLANTA (AP) - About one in 13 U.S. swine flu deaths have been children and most of the kids have been of school age, the federal government said Thursday in its first study of the new flu’s youngest victims.

Neighbors wears masks as they mourn the death of non-resident Indian Pravin Patel who died of swine flu in Ahmadabad, India, Sunday, Aug. 9, 2009. Patel, a 43-year-old who arrived in the city from Atlanta on July 31, died of swine flu early Sunday, a senior official said. With two deaths reported from Pune and one in Mumbai, Patel's is the country's fourth swine flu fatality according to news reports. (AP Photo/Ajit Solanki)

Neighbors wears masks as they mourn the death of non-resident Indian Pravin Patel who died of swine flu in Ahmadabad, India, Sunday, Aug. 9, 2009. Patel, a 43-year-old who arrived in the city from Atlanta on July 31, died of swine flu early Sunday, a senior official said. With two deaths reported from Pune and one in Mumbai, Patel's is the country's fourth swine flu fatality according to news reports. (AP Photo/Ajit Solanki)

More than 40 U.S. children have died from the virus since it was first identified in this country in April. The report from the U.S. Centers for Disease Control and Prevention takes a comprehensive look at the first 36 deaths, and found some important differences in the pediatric death toll from swine flu as compared to seasonal flu:

- Normally, half or more of the children who die from flu are age 4 and younger. But more than 80 percent of the kids who died with swine flu were 5 or older.

- Almost two-thirds of the children who died with swine flu had epilepsy, cerebral palsy or other neurodevelopmental conditions. In a previous flu season, only a third of pediatric deaths had those conditions.

- Bacterial co-infections were a big danger, and were blamed in most of the deaths of otherwise healthy children. Co-infections usually occur when a patient, weakened by a virus, then gets hit by a bacterial bug.

The CDC released the report through one of its publications, Morbidity and Mortality Weekly Report.

Swine flu has caused more than 1 million illnesses in the United States, the CDC estimates. More than 550 deaths and 8,800 hospitalizations have been reported to date.

It’s hard to say whether children have accounted for a higher proportion of deaths from swine flu than they normally do from seasonal flu, though CDC officials say that seems to be true. The CDC doesn’t monitor seasonal flu deaths as closely as it does swine flu, and it has no comprehensive count of annual seasonal flu deaths to enable such a comparison.

The new report focuses on lab-confirmed swine flu deaths reported through Aug. 8. The CDC hasn’t been able to do as complete an analysis of cases that have come in since then, said Dr. Cynthia Moore, a CDC medical officer who was one of the study’s co-authors.

Through Aug. 8, there were 477 total swine flu deaths, including 36 in children.

Only about 20 percent of those children were age 4 or younger. That’s unusual: Often 50 percent or more of seasonal flu deaths are in infants and toddlers, who have less mature immune systems and smaller air passages and are generally in more danger from respiratory infections.

“There’s a lot of school-aged children” in the death count, said Dr. Beth Bell, a CDC epidemiologist who is a leader in the agency’s swine flu response efforts.

It’s not clear why such a large percentage of the swine flu pediatric deaths are in kids aged 5 and older. It simply may be because older children were more likely to encounter the virus - at schools, summer camps - than very young children who spend more time at home, Bell said.

The initial numbers in the report are small and the CDC will need to look at more reports to see if the trends hold up, CDC officials said.

Two-thirds of the children who died had high-risk medical conditions. Nearly all of them had an illness related to the nervous system, including mental retardation, cerebral palsy and epilepsy and other seizure disorders.

Years ago experts recognized that children with neurodevelopmental conditions are at higher risk of serious complications from the flu. But the proportion of swine flu victims with that kind of underlying condition was swine flu percentages are high compared to a previous flu season, CDC officials said.

It’s not clear how significant that finding is, because many of the children had other medical problems that had weakened their bodies, CDC officials said.

Of the children who were healthy before they got swine flu, many were probably killed by a one-two punch of swine flu working with a bacterial co-infection, CDC officials said.

Bacterial co-infections have been an increasingly noticed danger since the government started tracking pediatric flu deaths in 2004. So their occurrence with swine flu was not a surprise, but emphasized the needs for parents and doctors to be alert to the danger and give the child antibiotics when appropriate, CDC officials said.

Wednesday, September 2, 2009

Government Pharmaceutical Org. in a race against time and virus mutation

[Opinion piece.]

Published: 2/09/2009 at 12:00 AM

Thailand has taken the unprecedented step of speeding up the manufacturing of vaccines to fight the type-A H1N1 flu pandemic. However, increasing concern over the vaccine's safety and its fast-track process could end up hurting the credibility of the much-awaited vaccine project, as well as the public's hopes of easy access to the domestic preventive tool.

The Government Pharmaceutical Organisation (GPO) earlier this year adopted the Russia-developed live-attenuated technology from the World Health Organisation as it allows a production of 30 times more vaccine doses than the inactivated technology.

The agency also plans to make the first lot of vaccines available by December, according to its original timeline.

Unfortunately, a recent report on mutation of the seed virus used for the vaccine production sent waves of concern among the experts. The incident caused them to wonder if the vaccine manufacturing process being undertaken at a pilot plant in Silpakorn University's faculty of pharmaceutical sciences in Nakhon Pathom province, should continue.

"Virus mutation and genetic changes in various spots have been detected during laboratory testing. Since the product is not heat-resistant, it may fail to protect people when it is sprayed in through the nose," said Thiravat Hemachudha, a virological expert at Chulalongkorn University's faculty of medicine.

The doctor suggested the government switch to using seed virus from China which is believed to be more stable, and renovate another vaccine plant, run by the Department of Livestock, at Pak Chong district in Nakhon Ratchasima. Its production capacity of 86 million flu vaccine doses would be sufficient for all Thai people, while the pilot plant at Nakhon Pathom has a maximum capacity of only 540,000 doses per month.

Other scientists and researchers criticised the low yield rate of the first batch of vaccine viruses. The disappointing result may have stemmed from both defects in the hen eggs imported from Germany and used for virus culture, or a lack of collaboration from partners involved in the project apart from the Public Health Ministry.

Witit Artavatkun, GPO managing director, defended the seed virus. He maintained that it had not changed or mutated into a virulent form.

"We did not see any significant genetic changes in the position that controls virulence of the seed virus," he said.

He disagreed with Dr Thiravat's recommendations. He said the seed virus from China was not certified by the WHO, and its egg-based production technology was not up-to-date. He also argued that it was impossible to convert the animal vaccine plant for the new purpose. The Department of Livestock plans to produce three animal vaccines. It could not stop its work just to allow the H1N1 project to take over.

The GPO has worked closely with both domestic and international partners. The WHO helps supervise every step of the vaccine manufacturing. The UN agency has actually granted the GPO US$4 million to develop a pilot plant from scratch.

According to the original schedule, Mahidol University's faculty of tropical medicine would be responsible for clinical trials set for early this month.

Vaccine development is considered a major scientific undertaking especially when it comes to global pandemic fears. This time the importance of making available a pandemic flu vaccine is higher than ever for both rich and poor nations.

The WHO has regarded the type A (H1N1) influenza as the most prevalent flu strain.

The virus could spread four times faster than other viruses and 40% of the fatalities are young adults in otherwise good health. Up to 30% of people in densely populated countries risk getting infected. Evidence from outbreak sites also shows the virus has rapidly established itself in the areas and become the dominant influenza strain in most parts of the world. The pandemic will persist in the coming months as the virus continues to move through susceptible populations. So far more than 2,185 people around the world have died from the virus since it emerged in April, according to the latest WHO figures. Thailand reported more than a hundred deaths from the type A (H1N1) pandemic.

Until now, the fatality rate of this influenza is still considered quite low. But history teaches us that the situation could take a turn for the worse during the next wave of the pandemic.

Since only a few countries in the world have plants for manufacturing influenza vaccine, and three companies - Glaxo-SmithKline, Sanofi-Pasteur and Novartis - account for most of the world's manufacturing capacity, the inconvenient truth is that the vaccine amount would not be nearly enough for everyone in the world.

WHO's director-general Margaret Chan said the world's production capacity would be only at 900 million doses a year compared to a global population of 6.8 billion.

Despite the hindrances, Thailand's efforts to make available domestic antiviral stockpiling and producing potentially life-saving vaccines should be applauded rather than booed.

For the first time the country will be able to successfully develop one of the key interventions for reducing local flu infections and deaths without solely relying on imported products. The government's support for the project also brings hope to the possibility of developing a sustainable system of healthcare and scientific research long neglected by previous policy-makers.

Dr Chan even said that political leadership is among the most important things in the battle against the virus.

Surely the safety and effectiveness of the vaccine cannot be compromised. At this point, both good governance and sincere effort from every stakeholder is much needed in seeking ways to overcome the obstacles and challenges of the vaccine manufacturing process. Cooperation is key to ensuring our national health security, that Thailand will be equipped with sufficient "weapons" to combat the virus and that the pandemic will not take too high a toll on the population.

Tuesday, September 1, 2009

Obama Urges Common Sense In Fighting Swine Flu

September 1, 2009 4:00 PM

Until the first several million doses of swine flu vaccine are available in at least a month, President Obama is urging Americans to take precautions that might help slow the spread of H1N1.

Wash your hands frequently. Sneeze and cough into your shirtsleeves. Stay home if you or your kids get infected by H1N1.

“Every American has a role to play in responding to this virus. We need state and local governments on the front lines to make antiviral medications and vaccines available, and be ready to take whatever steps are necessary to support the health care system,” Obama said today in the Rose Garden after being briefed on the federal effort to try to contain swine flu.

“We need hospitals and health care providers to continue preparing for an increased patient load, and to take steps to protect health care workers. We need families and businesses to ensure that they have plans in place if a family member, a child, or a co-worker contracts the flu and needs to stay home,” Obama added.

Obama is getting some help spreading the word from Sesame Street’s lovable Muppet Elmo:

- Ken Bazinet

THE WHITE HOUSE

Office of the Press Secretary

FOR IMMEDIATE RELEASE

September 1, 2009

2009-H1N1 National Preparedness and Response Overview

The health and safety of the American people is the first priority of President Barack Obama. Since the novel 2009-H1N1 flu virus emerged in the United States during the third week of April, the President has received regular briefings and asked his Cabinet to spare no effort in addressing this national security challenge. The Secretary of Health and Human Services is leading the way on public health preparedness and response efforts, the Principal Federal Official for domestic incidents, the Secretary of Homeland Security, is coordinating the supporting activities of Federal departments and agencies and facilitating response actions with State, local and territorial governments and tribal and private sector partners, while other Cabinet officials are leading complementary initiatives in their area of responsibility. It is a well-coordinated, all hands on deck approach. All Federal efforts are aimed at reducing the impact of 2009-H1N1 on the health and well-being of Americans and on the economy and functioning of society. Key elements of our preparedness and response efforts include:

Preparing for a fall wave of H1N1 flu with great team work across the Nation

Implementing a National Framework for 2009-H1N1 preparedness and response, including the four pillars of surveillance, mitigation, vaccine, and communications Partnering with Congress, governors, mayors, territorial and tribal officials, state and local health departments and emergency managers, the medical community, private-sector entities, and community-based groups for an effective response Issuing medical, science-derived public guidance for K-12 schools, institutions of higher education, businesses and employers, and families across the country available 24/7 on www.flu.gov

Making steady progress on developing a safe, effective, and voluntary H1N1 flu vaccine

Preparing for a voluntary, but strongly recommended, H1N1 flu shot program to be available to all Americans that wish to participate over a period of time

Encouraging Americans to act on a shared responsibility to reduce the impact of H1N1 flu

Calling on individuals and families to plan for the fall flu season and to take steps to prevent the spread of the H1N1 flu

To learn more about this virus, please go to www.flu.gov or talk to your doctor.


Read more: http://www.nydailynews.com/blogs/dc/2009/09/obama-urges-common-sense-in-fi.html#ixzz0Ptkz5LSO


hat-tip Sally

Monday, August 31, 2009

Return of swine flu: What’s ahead for Americans?

By LAURAN NEERGAARD
The Associated Press
Monday, August 31, 2009 3:13 AM



WASHINGTON — The alarm sounded with two sneezy children in California in April. Just five months later, the never-before-seen swine flu has become the world’s dominant strain of influenza, and it’s putting a shockingly younger face on flu.

So get ready. With flu’s favorite chilly weather fast approaching, we’re going to be a sick nation this fall. The big unknown is how sick. One in five people infected or a worst case - half the population? The usual 36,000 deaths from flu or tens of thousands more?

The World Health Organization predicts that within two years, nearly one-third of the world’s population will have caught it.

"What we know is, it’s brand new and no one really has an immunity to this disease," Health and Human Services Secretary Kathleen Sebelius says.

A lot depends on whether the swine flu that simmered all summer erupts immediately as students crowd back into schools and colleges - or holds off until millions of vaccine doses start arriving in mid-October.

Only this week do U.S. researchers start blood tests to answer a critical question: How many doses of swine flu vaccine does it take to protect? The answer will determine whether many people need to line up for two flu shots - one against swine flu and one against the regular flu - or three.

The hopeful news: Even with no vaccine, winter is ending in the Southern Hemisphere without as much havoc as doctors had feared, a heavy season that started early but not an overwhelming one. The strain that doctors call the 2009 H1N1 flu isn’t any deadlier than typical winter flu so far. Most people recover without treatment; many become only mildly ill.

Importantly, careful genetic tracking shows no sign yet that the virus is mutating into a harsher strain.

We’re used to regular flu that, sadly, kills mostly grandparents. But the real shock of swine flu is that infections are 20 times more common in the 5- to 24-year-old age group than in people over 65. That older generation appears to have some resistance, probably because of exposure decades ago to viruses similar to the new one.

Worldwide, swine flu is killing mostly people in their 20s, 30s and 40s, ages when influenza usually is shrugged off as a nuisance.

Especially at risk are pregnant women. So are people with chronic conditions such as asthma, diabetes, heart disease and neuromuscular diseases including muscular dystrophy. Some countries report more deaths among the obese.

Still, some of the people who’ve died didn’t have obvious health risks.

"People who argue we’re seeing the same death rates miss the point - they’re in young adults. To me, that shouldn’t happen," said one infectious disease specialist, Dr. Richard P. Wenzel of Virginia Commonwealth University. He spent the past few months visiting South American hospitals to help gauge what the Northern Hemisphere is about to face.

Children, however, are the flu’s prime spreaders. Already, elementary schools and colleges are reporting small clusters of sick students. For parents, the big fear is how many children will die.

Panicked crowds flooded India’s hospitals in August after a 14-year-old girl became that country’s first death. In the U.S., regular flu kills 80 to 100 children every winter, and the Centers for Disease Control and Prevention has reports of about three dozen child deaths from swine flu.

Even if the risk of death is no higher than in a normal year, the sheer volume of ill youngsters means "a greater than expected number of deaths in children is likely," said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases. "As a society, that’s something that’s much harder for us."

Swine flu quietly sickened hundreds in Mexico before U.S. researchers stumbled across two children in San Diego who had the same mystery illness. A world already spooked by the notorious Asian bird flu raced to stem the spread of this surprising new virus. Mexico closed schools and restaurants, and barred spectators from soccer games; China quarantined planeloads of tourists. But there was no stopping the novel H1N1 - named for its influenza family - from becoming the first pandemic in 41 years.

Well over 1 million Americans caught swine flu in spring and summer months when influenza hardly ever circulates; more than 500 have died.

In July, England was reporting more than 100,000 infections a week.

Argentina gave pregnant women 15 paid days off last month at the height of its flu season, hoping that staying home would prove protective.

In Saudi Arabia, people younger than 12 and older than 65 are being barred from this November’s hajj, the pilgrimage to holy cities that many Muslims save up their whole lives to make.

And in Australia - closely watched by the U.S. and Europe as a predictor for their own coming flu seasons - hospitals set up clinics outside the main doors to keep possible flu sufferers from entering and infecting other patients.

"While this disease is mild for most people, it does have that severe edge," said Australia’s health minister Nicola Roxon, who counted over 30,000 cases in a country of nearly 22 million. That’s comparable to its last heavy flu season in 2007.

Cases are dropping fast as winter there ends. But Australia still plans to start the world’s first large-scale vaccinations next month in case of a rebound, inoculating about 4 million high-risk people.

Most amazing to longtime flu researchers, this new H1N1 strain seems to account for about 70 percent of all flu now circulating in the world. In Australia, eight of every 10 people who tested positive for flu had the pandemic strain.

That begs the question: Do people still need to bother with regular flu vaccine?

Definitely, stressed CDC’s Schuchat, who plans to get both kinds. There’s still enough regular flu circulating to endanger people, especially the 65-and-older generation.

Notably, South Africa is having a one-two punch of a flu season, hit first with a seasonal strain known as H3N2 and now seeing swine flu move in.

Wash your hands, sneeze into your elbow, stay home so you don’t spread illness when you’re sick. That’s the mantra until vaccine arrives.

This week brings a key milestone. Hundreds of U.S. adults who rolled up their sleeves for a first shot in studies of the swine flu vaccine return for a blood test to see if they seem protected. It will take government scientists a few weeks to analyze results, but the volunteers get a second vaccine dose right away, in case the first wasn’t enough.

The vaccine, merely a recipe change from the usual flu vaccine, seems safe. Federal authorities two weeks ago gave the go-ahead to start children’s vaccine trials.

"It’s been a piece of cake," said Kate Houley of Annapolis, Md., who jumped at the chance to enroll her three sons, ensuring that if the vaccine really works, they’ll have some protection as school gets started. Eleven-year-old Ethan was among the first to be vaccinated by University of Maryland researchers and didn’t even report the main side effect - a sore arm.

In the U.S., Britain and parts of Europe, vaccinations are set to begin in mid-October, assuming those studies show they work. First in line:

-Pregnant women. Despite accounting for about 1 percent of the U.S. population, they’ve been accounting for 6 percent of the swine flu deaths.

-Children and young adults from 6 months to 24 years. Babies younger than 6 months can’t get flu vaccine, so their parents and other caregivers should be inoculated to protect the infant.

-Health care workers.

-Younger adults with risky health conditions.

Schools around the U.S. are preparing to inoculate children in what could be the largest campus vaccinations since the days of polio. The government has bought 195 million doses and will ship them a bit at a time, starting with 45 million doses or so in October, to state health departments to dispense.

The Association of State and Territorial Health Officials is negotiating with pharmacists to help perform those vaccinations. Massachusetts even is deputizing dentists to help give swine flu vaccine, and passed emergency regulations to encourage more health care workers to get either the shot or a nasal spray version.

What if people not on the priority list show up? The idea is for pharmacists to gently encourage them to come back a few weeks later, said the association’s executive director, Dr. Paul Jarris.

A concern is whether enough people are worried about swine flu to get vaccinated.

"Complacency is a big challenge," said CDC’s Schuchat. "We are trying to strike a balance between complacency and alarm."

Ten-year-old Isabella Nataro had a cousin sent home from summer camp because of an outbreak, and she readily agreed when her mother, a University of Maryland vaccine researcher, signed her and her brothers up for a study of the new shot. (The store gift card that participating kids receive after each blood test was a bonus.)

"I’m kind of worried about my friends if swine flu does come to our school," the suburban Baltimore girl said. "I hope everybody else at my school gets a chance to get it."

H1N1 DISCOVERED IN POULTRY

Aug. 31, 2009
Source: U.N.'s Food and Agriculture Organization (FAO) news release

The detection of an H1N1 virus in turkeys in Chile raises concern that poultry farms elsewhere in the world could also become infected with the pandemic flu virus currently circulating in humans, FAO said yesterday.

Chilean authorities reported on 20 August that the pandemic H1N1/2009 virus was present in turkeys in two farms near the seaport of Valparaiso, Chile. The flu strain found in the poultry flocks is identical to the H1N1/2009 pandemic strain currently circulating among human populations around the world.

No immediate threat to humans

However, the discovery of the virus in turkeys does not pose any immediate threat to human health and turkey meat can still be sold commercially following veterinary inspection and hygienic processing.

"The reaction of the Chilean authorities to the discovery of H1N1 in turkeys -- namely prompt reporting to international organizations, establishing a temporary quarantine, and the decision to allow infected birds to recover rather than culling them -- is scientifically sound," said FAO's interim Chief Veterinary Officer, Juan Lubroth.

"Once the sick birds have recovered, safe production and processing can continue. They do not pose a threat to the food chain," said Lubroth.

Disease monitoring

The current H1N1 virus strain is a mixture of human, pig and bird genes and has proved to be very contagious but no more deadly than common seasonal flu viruses. However, it could theoretically become more dangerous if it adds virulence by combining with H5N1, commonly known as avian flu, which is far more deadly but harder to pass along among humans.

"Chile does not have H5N1 flu. In Southeast Asia, where there is a lot of the virus circulating in poultry, the introduction of H1N1 in these populations would be of a greater concern," said Lubroth.

This is one reason why FAO encourages improved monitoring of health among animals and ensuring that hygienic and good farming practice guidelines are followed, including protecting farm workers if animals are sick and not allowing sick workers near animals.

"We must monitor the situation in animals more closely and strengthen veterinary services in poor and in-transition countries. They need adequate diagnostic capability and competent and suitably resourced field teams that can respond to emergency needs," Lubroth said.

This phenomenon is called genetic reassortment or recombination -- which may happen in case of simultaneous viral infections of any of the hosts.

This is now the fourth country that is investigating the spill-over of H1N1/2009 virus from farm workers showing flu-like illness to animals, with swine becoming infected in Canada, Argentina and, most recently, Australia.

Even though the clinical infections in pigs and turkeys so far observed have been generally mild, it is important to bear in mind that the establishment of pandemic H1N1 virus in pig and poultry farms has the potential to bring about negative economic consequences such as trade related restrictions and misguided perceptions of the quality and safety of meat products, according to FAO.

The emergence of new influenza virus strains capable of affecting humans and domestic animals remains a broader, more general concern that is being closely monitored by FAO, the World Organization for Animal Health (OIE) and the World Health Organization.

Tamiflu misuse yielding drug-resistant strains of H1N1 virus

Indiscriminate use of antiviral medications making fight against swine flu much harder

August 31, 2009
Indiscriminate use of antiviral medications to prevent and treat influenza could ease the way for drug-resistant strains of the H1N1 virus, or swine flu, to emerge, public health officials warn -- making the fight against a pandemic that much harder.

Already, a handful of cases of Tamiflu-resistant H1N1 have been reported this summer, and there is no shortage of examples of misuse of the antiviral medications, experts say.

People often fail to complete a full course of the drug, according to a recent British report -- a scenario also likely to be occurring in the U.S. and one that encourages resistance.

Stockpiling is rife, and some U.S. summer camps gave Tamiflu prophylactically to healthy kids and staff. Experts anticipate more problems now as children return to school and flu season draws near.

"Influenza viruses mutate frequently, and any viral resistance could be acquired easily," said Dr. Anne Schuchat, director of the National Center on Immunization and Respiratory Disease at the Centers for Disease Control and Prevention in Atlanta. "It won't surprise us if we see resistance emerge as a bigger problem in the fall or in the years ahead."

Prescribed in pill form, Tamiflu works by preventing the flu virus from leaving infected cells and spreading to new ones. Because a vaccine against pandemic H1N1 influenza will not be widely available for several months, Tamiflu and to a lesser extent Relenza, an antiviral that acts similarly, are key medical tools for fighting the pandemic in the meantime.

This month, the World Health Organization advised doctors that even those sickened with the H1N1 virus do not need to be given Tamiflu or Relenza if they are mildly or moderately sick and are not in a high-risk group (such as children younger than 5, pregnant women and those with an underlying health condition).

Both drugs can help prevent illness in people exposed to the virus and reduce illness severity in people already sickened.

U.S. health authorities and those elsewhere are keeping a sharp eye on prescriptions of the drug as they prepare for a surge of H1N1 cases in the fall. The government has issued detailed guidelines on prescribing antivirals.

sroan@tribune.com

Japan: boy is 5th case of Tamiflu resistant H1N1

Excerpt:

August 30th, 2009

In Shiga Prefecture, a 5-year-old boy infected with swine flu showed signs of resistance toward Tamiflu, the prefecture said Saturday, becoming the fifth Tamiflu-resistant patient in the country.

Prefecture officials said the virus is likely to have mutated in his body.

Although the boy was given Tamiflu, he showed no signs of recovery and was admitted to a hospital, the officials said, adding he has now fully recovered from the virus.

hat-tip Dutchy

Egypt: Confirmed H5N1 Cases

Listed by Age, Location, Onset Date and # confirmed by Min. of Health
  • 34 yo Tanta, [Gharbia Gov.] April 21 #68
  • 5 yo Tama [Sohag Gov.] May 7 #69
  • 4.5 yo Kafr Saqr [Ash Sharqiyah Gov.] May 10 #70
  • 4 yo Hashim, Mahalla [Gharbia Gov.] May 12 #71
  • 4 yo Ghamr [Dakahlia Gov.] May 9 #72
  • 4 yo Sherbin Dakahliy [Dakahlia Gov] May 18 #73
  • 3 yo Sohag [Sohag Gov] May 17 #74
  • 4 yo Hehia, [Ash Sharqiyah Gov.] May 24 #75
  • 4 yo Abo Hammad (Ash Sharqiyah] May 23 #76
  • 14 mos. Dekerness [Dakahlia Gov.] May 25 #77
  • 4 yo El Sheikh [Ash Shaykh Gov.] May 30 #78
  • 1.5 yo Albesartp [Damietta Gov.] June 1 #79
  • 4 yo Maniya [Dakahlia Gov] June 5 #80
  • 1 yo Kulain [Ash Shaykh Gov.] June 16 #81
  • No Age Sidi Ghazi [Ash Shaykh Gov.] July 24 #82
  • 1.6 yo Shebin [Menoufia Gov.] July 28 #83
  • 2 yo Berket al-Saba [Menoufia Gov.] August 23 #84
  • 14 yo Damietta [Damietta Gov.] August 21 #85
  • No Age Halouasy Echmoun [Menoufia Gov.] Posted 9/13 #86