Wednesday, December 02, 2009
Wednesday, November 25, 2009
India’s largest study to estimate Diabetes and Hypertension prevalence amongst outpatients across 10 States
It is well-known that India is rapidly becoming the diabetes capital of the world. But how many of us realize that diabetes and hypertension are together becoming a Twin Epidemic in India?"
Saturday, November 14, 2009
At Friday’s CDC press briefing on 2009 H1N1 flu, Dr. Anne Schuchat stressed the importance of antiviral drugs for severe illness and directed clinicians to a fact sheet on “some of the myths and misconceptions about antivirals.”
Among the CDC’s “Quick Facts for Clinicians on Antiviral Treatments for 2009 H1N1″:
- Although initiating treatment within 48 hours of symptom onset is preferable, many patients (including those hospitalized or at high risk for severe illness) may still benefit if treatment is started later.
- While antivirals are advised for patients with heightened risk, even those without risk factors might benefit, making clinical judgment “essential.”
- If flu is suspected and treatment seems warranted, antivirals should be started before laboratory confirmation of illness.
By current knowledge, a surgical mask is sufficient. Save N95 respirators for TB and other aerosol-transmitted diseases. (more…)"
Saturday, November 07, 2009
Mandatory Vaccination of Health Care Workers
Alexandra Stewart writes that mandatory vaccination of health care workers raises important questions about a state’s power to compel individuals to engage in particular activities in order to protect the public.
CDC Health Alert Network (HAN) Info Service Message: Key Issues for Clinicians Concerning Antiviral Treatments for 2009 H1N1
Saturday, October 31, 2009
October 23, 2009, 4:30 PM ET
What is Pneumococcal Disease?
Pneumococcal disease is an infection caused by a type of bacteria called Streptococcus pneumoniae (pneumococcus). When these bacteria invade the lungs, they can cause pneumonia. They can also invade the bloodstream (bacteremia) and/or the tissues and fluids surrounding the brain and spinal cord (meningitis). Pneumococcal infection kills thousands of people in the United States each year, most of them 65 years of age or older.
What are the Symptoms of Pneumococcal Disease?
The symptoms of pneumococcal pneumonia include fever, cough, shortness of breath, and chest pain. The symptoms of pneumococcal meningitis include stiff neck, fever, mental confusion and disorientation, and visual sensitivity to light (photophobia). The symptoms of pneumococcal bacteremia may be similar to some of the symptoms of pneumonia and meningitis, along with joint pain and chills.
Why is Prevention of Pneumococcal Disease Important during Influenza Season?
Influenza infections can make people more likely to develop bacterial pneumonia. Pneumococcus is the most common cause of bacterial pneumonia. Pneumococcal infections are a serious complication of seasonal and 2009 H1N1 influenza infections and can cause death."
Click on link above for more.......
2009-2010 Influenza Season Triage Algorithm for Children (18 years or Younger) With Influenza-Like Illness (PDF)
Wednesday, October 21, 2009
Tuesday, October 20, 2009
Questions and Answers: Opening and Mixing Tamiflu Capsules with Liquids if Child Cannot Swallow Capsules
Pediatric Supplement: Recommendations for use of antiviral medications for 2009 H1N1 influenza in children and adolescents
Questions and Answers Regarding Respiratory Protection For Preventing 2009 H1N1 Influenza Among Healthcare Personnel
Tuesday, October 13, 2009
Children aged 6 months through 9 years should receive two doses of 2009 H1N1 vaccine roughly 4 weeks apart, the CDC announced in MMWR.
The report details the differing age-range approvals for the manufacturers:
- CSL’s vaccine is approved for use in people 18 years and older (one dose, IM);
- Novartis’, for ages 4 and up (one dose, IM, except for children under 10, who get two);
- Sanofi Pasteur’s, for ages above 6 months (one dose, IM, except for children under 10);
- MedImmune’s, for ages 2 to 49 (one dose, intranasally, except for children under 10).
The injectable formulations are adjuvant-free and contain inactivated virus; the intranasal formulation contains live attenuated virus and shouldn’t be administered to children under 2, adults over 49, pregnant women, people with medical conditions that put them at higher risk for flu complications, and children under 5 who’ve had a wheezing episode within a year. All the vaccines contain egg protein, and the article’s table provides details on those containing mercury."
Sunday, October 11, 2009
H1N1 flu taking off in us, officials say
Although it is not quite at epidemic levels yet, H1N1 is spreading in many states at a time when normally there is little or no influenza, the US Centers ...
The abcs of H1N1Edmonton Sun
Seasonal flu vaccine lessens H1N1 impactNDTV.com
Children's deaths increase from H1N1 virus, protection is critical: CDCFood Consumer
Washington Post -Cleveland Daily Banner -Livingston Daily
all 6,288 news articles »
Saturday, October 10, 2009
Standard surgical masks are as effective as fit-tested N95 respirators in protecting healthcare workers against influenza, according to a JAMA report published online.
Some 450 Ontario nurses working in emergency departments, medical units, and pediatric units were randomized to use either a fit-tested N95 respirator or a surgical mask when caring for patients with febrile respiratory illnesses during the 2008-2009 flu season. By study’s end, roughly 23% of each group had suffered a laboratory-confirmed influenza infection, showing the noninferiority of surgical masks for protection.
The authors warn that their results “should not be generalized to settings where there is a high risk for aerosolization, such as intubation or bronchoscopy, where use of an N95 respirator would be prudent.”
Editorialists say that masks and respirators should be considered the “last line of defense” in infection control in influenza, with the first being annual vaccination of healthcare personnel."
WHO: Recommended Composition of Influenza Virus Vaccines for use in the 2010 Southern Hemisphere Influenza Season
Friday, October 02, 2009
Novel H1N1 Influenza and Respiratory Protection for Health Care Workers
K.I. Shine, B. Rogers, and L.R. Goldfrank
Guidelines from the CDC recommend the use of an N95 filtering facepiece respirator. Drs. Kenneth Shine, Bonnie Rogers, and Lewis Goldfrank discuss the efficacy of personal respiratory protection measures, medical masks, and respirators.
CDC and FDA Response to Risk of Confusion in Dosing Tamiflu Oral Suspension
D.S. Budnitz and Others
Together, the CDC and the FDA have acted promptly to provide information that emphasizes appropriate dosing and dispensing of Tamiflu for oral suspension.
WHO Director General Dr. Margaret Chan Address to the Regional Committee of the Americas: Pandemic Flu
Updated Questions and Answers: Use of Antiviral Medicines for the Treatment and Prevention of Flu among Pregnant Women for the 2009–2010 Season
Monday, September 28, 2009
Comparative Efficacy of Inactivated and Live Attenuated Influenza Vaccines
A.S. Monto and Others
Data are scarce regarding the comparative efficacies of the inactivated (intramuscular administration) and live attenuated (intranasal administration) seasonal influenza vaccines. During the 2007–2008 influenza season, 1952 healthy young adults were enrolled in a randomized, double-blind, placebo-controlled study of these two vaccines. The inactivated vaccine was found to have an absolute efficacy of 68%, whereas the live attenuated vaccine had an absolute efficacy of 36%.
24 September 2009
Director-General Statement following the fifth meeting of the Emergency Committee
The Emergency Committee held its fifth meeting, via e-mail, concluding on 23 September 2009.
The Committee considered a proposal from the WHO Director-General regarding the continuation of three temporary recommendations issued under the IHR with respect to the on-going public health emergency of international concern. There was a consensus on continuing the three temporary recommendations proposed by the Director-General.
Having considered the views of the Emergency Committee, and the ongoing pandemic situation, the Director-General determined it was appropriate to continue these temporary recommendations, namely:
•countries should not close borders or restrict international traffic and trade;
•intensify surveillance of unusual flu-like illness & severe pneumonia; and
•if ill, it is prudent to delay international travel -- if ill after travel seek care.
Questions and AnswersUse of Antiviral Medicines for the Treatment and Prevention of Flu among Pregnant Women for the 2009–2010 Season
Use of Antiviral Medicines for the Treatment and Prevention of Flu among Pregnant Women for the 2009–2010 Season: "Pregnant women who are healthy have had severe illness from the 2009 H1N1 flu (also called “swine flu”). Compared with people in general, pregnant women with 2009 H1N1 flu have been more likely to be admitted to hospitals. Some pregnant women have died. For this reason, CDC advises doctors to give antiviral medicines that treat 2009 H1N1 flu to pregnant women who have symptoms of flu."
Wednesday, September 23, 2009
Flu Can Raise Chances of Heart Attack
U.S. News & World Report
Because both seasonal and the pandemic H1N1 swine flu are circulating this fall and winter, people at risk for heart attacks are urged to get a seasonal flu ...
Flu can trigger heart attack: LancetPress Trust of India
Heart attack swine flu link discoveredNursing Times
Flu boosts heart-attack risk, says studyAFP
Times Online -The Press Association -PRESS TV
all 254 news articles »
How should providers prioritize among the initial target groups recommended by ACIP?
How will the 2009 H1N1 vaccine flow from manufacturers to providers?
Saturday, September 19, 2009
First Swine Flu Vaccines Will Likely Be Needle-Free
The first round of swine flu vaccinations may be administered with a needle-free nasal spray version, government health officials said Friday. ...
and more »
Statement by WHO Director-General Dr. Margaret Chan on Pandemic Vaccine Donations for the Developing World
Thursday, September 17, 2009
The FDA approved four vaccines against 2009 H1N1 influenza on Tuesday, according to an agency news release. Package inserts can be obtained here. Several studies have showed that most healthy adults had a strong immune response after one dose (see the recently published research from the New England Journal of Medicine). An optimum dosing schedule for children has not yet been determined.
National distribution of the initial lots is expected within 4 weeks."
Microsoft urges Web learning in case of swine flu
The Associated Press
SEATTLE — Microsoft Corp. says it can help schools get through swine flu. The company is promoting its free online service for storing files and ...
Tuesday, September 15, 2009
How did Marketing Madness come about?
I was a final year marketing student from the University of Melbourne when I decided to stay in Melbourne and secure a full-time job. The fact that I was an international student without permanent residency meant that no major company was willing to take me on. Even smaller firms were reluctant to consider me although I was planning to apply for permanent residency as soon as I graduated. Two weeks into job hunting and no callbacks, I knew I had to do something. Marketing Madness was born.
What's so great about blogging?
Once I had it up and running, I started to realise how much I actually like blogging. Here are two main reasons why I think blogging is good for the soul:
Knowledge is power- Before I started this blog, I had no idea what social media was and I knew zilch about current trends in the marketing industry. Starting this blog made me reach out and learn new things. Decent memorising and analytical skills with little bit of bullshitting takes you a long way in university, but that's not always the case in real life (although it might be if you're a consultant). So do yourself a favour and get enlightened.
Networking- Blogging and twittering (or tweeting?) has helped me connect with people from all walks of life and not just from the marketing industry. It's amazing what you can learn from others. There are so many sources of inspiration, ideas and creativity you can leverage from that are just waiting to be discovered. Join communities, initiate discussions and maybe even start something yourself. You might soon be an addict.
Within a week of advertising my blog in my resume, I received one job offer and two invites for interviews. I decided to pursue a different route, but this just goes to show that blogging is an awesome way to put yourself out there and get noticed by the right people.
Don't let the critics break your stride
If you're doing something you love and getting recognised for it, there will be critics. And no, I'm not talking about people who actually read your blog and offer constructive criticism. I'm talking about annoying bubble bursters who are a complete waste of oxygen. Blogging is something I enjoy doing. I love sharing my opinions, ideas or just new things I discover. So, as long as I see value in it, I will continue to do so.
Thank you my readers for sticking around. You rockkk!
Statement by Dr. Anthony Fauci, Director, National Institute of Allergy and Infections Diseases, NIH, Regarding Early Results from Clinical Trials of 2009 H1N1 Influenza Vaccines in Healthy Adults
Saturday, September 12, 2009
Opposition to swine flu vaccine seems to be growing worldwide.
Authors: Kmietowicz Z
PMID: 19710128 [PubMed - indexed for MEDLINE]"
Should healthcare workers have the swine flu vaccine?
Authors: Jordan R, Hayward A
PMID: 19706938 [PubMed - indexed for MEDLINE]"
Target groups for initial vaccine supplies include pregnant women as well as children and young adults.
The CDC has released its recommendations for use of influenza A (H1N1) 2009 monovalent vaccine. Although the vaccines are not licensed yet, the target date for the first available supply is mid-October 2009. State and local health officials will distribute vaccines, depending on local conditions. READ MORE…"
Sunday, September 06, 2009
Dr Marie-Paule Kieny
Dr Marie-Paule Kieny is director of the Initiative for Vaccine Research at the World Health Organization (WHO). She received a degree in Economics in 1977, followed by a PhD in microbiology in 1980, both from the University of Montpellier in France. Her research career began with the development of a recombinant rabies vaccine. Since then, she has worked on the design of AIDS vaccine candidates and done research on cancer immuno-gene therapy, targeting mainly breast and cervical cancers. She has also served on several expert committees on vaccine discovery, AIDS and cancer research.
The vast majority of cases of pandemic influenza A (H1N1) have been mild so far with few deaths. It remains to be seen whether the virus will mutate into a more virulent strain. Marie-Paule Kieny explains how WHO is supporting countries’ efforts to protect their populations with vaccines that should become available as of this month.
Q: When will the first doses of vaccine for the pandemic influenza A (H1N1) be ready?
A: Some manufacturers announced in July that vaccine is available, but that doesn’t mean it’s ready for use, as it needs regulatory approval. Regulatory authorities are considering the best way to register these vaccines as quickly as possible. The consensus is that the first doses will be available to governments for use in September.
Q: Who will get vaccinated first? Who decides this?
A: Vaccine will not be available on the private market and governments will decide who gets vaccinated first. WHO recommends that health workers be the first, to protect the health system and allow them to care for influenza and other patients. The strategy a country takes will depend on its policy objectives and the availability of vaccine. For example, if a country decides to concentrate on protecting essential infrastructure, it may target different people, such as truck drivers, if they are critical for food delivery. Others may try to reduce transmission of the virus. For example, the United States of America decided to immunize children before or at school entry who are in closer physical contact than adults and can amplify infection rates. Countries may also try to reduce morbidity and mortality and target specific groups, such as pregnant women. Some high-income countries have ordered enough vaccine for the whole population. Nevertheless, no countries will have vaccine for everyone from the first day it is available for use, so that each country will need to prioritize. Some middle-income countries have also placed contracts with pharmaceutical companies and have been purchasing vaccine for between 1% and 10–20% of the population. WHO is working hard with manufacturers, governments and donors to ensure that developing countries can access vaccine as soon as possible to immunize their health workers, and when more vaccine becomes available, other groups will be immunized.
Q: How are influenza vaccines produced?
A: The main method is by injecting seed virus into embryonic chicken eggs and harvesting the fluid after several days and purifying it. There are two technologies. More than 90% of influenza vaccines available are known as “inactivated vaccines”, which means you kill the virus to produce the vaccine. Less common are “live attenuated vaccines”, which are derived from a weakened form of the virus that is not killed.
Q: How many different vaccine candidates will be available for A (H1N1)?
A: About 30. Most will be inactivated virus vaccines made in eggs, some will be killed virus vaccines made in cell cultures and a few will be live attenuated virus vaccines. Then you have a lot of variation in the way vaccine is purified and in whether or not it is mixed with an additive, called an adjuvant, which is a booster of immunogenicity (which is the capacity of a vaccine to evoke an immune response) and which is used with killed virus vaccine. All vaccines create antibodies to fight the virus; some will produce a local response, such as attenuated vaccine administered in the nose to give more immunity at the port of entry of the virus. The industry will use tiered pricing, so high-income countries might pay between US$ 10–20 per dose, middle-income countries may pay about half that and low-income half that price again. These are ballpark figures but this is the order of magnitude.
Q: Isn’t it too early to produce vaccines because the pandemic virus could mutate?
A: Although the virus can mutate, we hope that there will be enough cross-protection through recognition of the new virus. But if the virus changes too much, we will need new vaccines.
Q: WHO has recommended the use of adjuvant in pandemic vaccines, but some countries don’t plan to follow this guidance.
A: Many countries, including the USA, have not licensed vaccines with adjuvants of any kind yet. Other vaccines with the same type of adjuvant as planned for pandemic influenza A (H1N1) vaccines have, however, been licensed in European countries. Countries that intend to use vaccine with adjuvant will find that there is a large body of safety data for adults and some for children. In any case, all countries will need to carry out good post-marketing surveillance to make sure that they pick up any early sign of a safety problem with a particular vaccine.
Q: These must be the fastest vaccines ever produced. Given their fast-tracking, what is the guarantee of safety and efficacy?
A: The testing of influenza vaccines is different from that of other vaccines, because the rabies and measles vaccines for example do not change. Since influenza viruses evolve constantly, it is impossible to carry out a complete clinical analysis of seasonal influenza vaccines yearly because the composition changes each year to adapt to the virus and so you are always a year behind. A complete clinical evaluation is not needed also because manufacturers produce seasonal influenza vaccines using the same procedure and equipment, but for a different virus each year. In the USA, vaccines for seasonal influenza are licensed without clinical trials on the basis of a “strain change”. The US regulatory authorities consider the change from seasonal to pandemic H1N1 influenza vaccine production (using the same procedure) as a change in the strain and therefore will not request clinical trials before registration. Having said that, all manufacturers will perform clinical trials to find out whether one or two doses are necessary, to test it in special populations and to administer it jointly with other vaccines. In Europe, a strain change is accompanied by a small clinical trial requested by the European Medicines Agency. In the last couple of years, manufacturers in the European Union registered “mock-up” or prototype H5N1 bird flu vaccines as nobody knows which H5N1 strain might become a pandemic strain. Manufacturers made clinical batches of an H5N1 vaccine with virus stocks from China, Indonesia and Viet Nam. They carried out clinical trials and submitted the results to the regulatory authorities who said the vaccines were fine. They are not allowed to sell H5N1 vaccines, since there is no H5N1 pandemic, but they can use the same procedure to make H1N1 pandemic vaccine. That way they can get a licence in a few days. This is another way vaccines can be licensed without clinical trials, while still ensuring safety on the basis of what is known about influenza vaccines. Based on the extensive knowledge available on seasonal vaccines and the results obtained through evaluation of H5N1 avian influenza vaccines, there is no doubt that it will be possible to make effective H1N1 pandemic vaccines.
Q: What’s been done to ensure that developing countries get enough vaccine?
A: It depends on what we mean by “enough”. Some countries want to vaccinate every member of the population, but there is no way we can do this for the whole world. WHO has a cross-organizational operation that is in place to secure vaccines for developing countries. This is spearheaded by the Director-General’s Office and the legal and vaccine departments. We are engaged in three types of activities. The first is to negotiate donations with manufacturers. Two have been announced: 100 million doses by sanofi-aventis and 50 million doses from GlaxoSmithKline. Second, we are working with other manufacturers to reserve a portion of their vaccine production for WHO at a reduced price. Third, we are working with governments to raise funds to purchase vaccines. We are also working with 11 vaccine manufacturers based in developing countries, providing them with seed financing and technical expertise to help them produce influenza vaccine domestically. We have also helped them access technology and given them sub-licences to use technology for producing live attenuated vaccine. These 11 companies will be manufacturing some of the 30 different expected vaccines.
Q: What happens if developing countries have only partial coverage?
A: Coverage will be partial and not only in developing countries. But we should not be “hypnotized” by vaccines. There are other measures, such as social distancing, school closure, avoidance of large gatherings, antibiotics and personal hygiene. This is not like rabies, which is 100% fatal: we are talking about a disease from which most people recover very well. We will try to help countries to gain access to as much vaccine as possible, at least to preserve their health systems functioning, but there is just not enough vaccine for every country in the world to vaccinate every member of the population twice. ■
H1N1 Influenza, Public Health Preparedness, and Health Care Reform
In December 2009, the Department of Health and Human Services will present to Congress its first-ever national health security strategy. Dr. Nicole Lurie writes that national health security will not be achievable without key elements of reform.
CDC Guidance on Helping Child Care and Early Childhood Programs Respond to Influenza during the 2009-2010 Influenza Season
Thursday, August 27, 2009
CDC warns swine flu could kill 90000 Americans
Even with little information on where, when or how bad h1n1 may hit, hospitals are having to plan for what could be a flood of sick patients. ...
WHO Issues Guidelines for Antiviral Treatment for H1N1 and Other ...
August 25, 2009 — The World Health Organization (WHO) has issued guidelines for antiviral treatment for novel influenza A (H1N1) and other influenza. ...
WHO: Asia will be short of swine flu vaccine
HONG KONG - Asia is going to be way short of the new H1N1 vaccine to fight swine flu when the next surge of infections hits during the cold season this year ...
Tuesday, August 25, 2009
This may be slightly weird to those who are non-Malaysians, but shopping malls in some areas here actually charge people to use the public toilets. Yup, the rate is about 30 sen (Malaysian currency). They're usually not any better than your average Malaysian public toilet- which stinks of urine with dodgy-looking litter in conspicuous areas.
Anyway, we were walking in a shopping mall in Sabah, when my Aussie friend and hygiene-freak of a sister needed to go to a restroom. They were well-aware of the notoriously grimy state of most Malaysian public toilets and looked for one warily. Then, we saw this sign:
'Platinum Club' VIP Public toilets. The rate? RM 1.00 per entry.
Now to some people (me), this may sound like a complete rip-off. The idea that I have to pay to use the toilet already sounds crazy to me. To top it off, they want to charge me a 'premium' price? But to my friend and sister, this looked like a highly promising offer.
Fifteen minutes later, they emerged glowing with satisfaction. Not only was it free of dodgy litter, it smelt good. And Justin Timberlake was playing on the speakers. Kudos to the person who came up with this brilliant idea!
Sunday, August 23, 2009
Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring: CDC Planning Recommendations for State, Local, Tribal, and Territorial Health Officials
WHO Guidelines for Pharmacological Management of Pandemic (H1N1) 2009 Influenza and other Influenza Viruses
Sunday, 23 August 2009 07:52 Added by PT Editor Sarah Price
Washington, August 23, 2009, (Pal Telegraph) - Government health officials are mobilizing to launch a massive swine flu vaccination campaign this fall that is unprecedented in its scope -- and in the potential for complications.
The campaign aims to vaccinate at least half the country's population within months. Although more people have been inoculated against diseases such as smallpox and polio over a period of years, the United States has never tried to immunize so many so quickly.
But even as scientists rush to test the vaccine to ensure it is safe and effective, the campaign is lagging. Officials say only about a third as much vaccine as they had been expecting by mid-October is likely to arrive by then, when a new wave of infections could be peaking.
Among the unknowns: how many shots people will need, what the correct dosage should be, and how to avoid confusing the public with an overlapping effort to combat the regular seasonal flu.
To prepare, more than 2,800 local health departments have begun recruiting pediatricians, obstetricians, nurses, pharmacists, paramedics and even dentists, along with a small army of volunteers from churches and other groups. They are devising strategies to reach children, teenagers, pregnant women and young and middle-aged adults in inner cities, suburban enclaves and the countryside.
"This is potentially the largest mass-vaccination program in human history," said Howard Markel, a professor of medical history at the University of Michigan who is advising the Centers for Disease Control and Prevention as it spearheads the effort.Public health officials describe the effort as crucial to defend against the second wave of the Northern Hemisphere's first influenza pandemic in 41 years.
As schools reopen, the number of cases could jump sharply within weeks, sparking a second wave potentially far larger than the outbreak last spring. Although the swine flu appears no more dangerous than the typical seasonal flu, the new virus -- known as H1N1 -- is likely to infect many more people because most have no immunity against it.
The vaccine effort carries political risks for the Obama administration. "If the outbreak fizzles, they will be susceptible to being criticized for spending billions of dollars," said Harvey V. Fineberg, president of the National Academy of Sciences' Institute of Medicine, which advises Congress about medical issues. "On the other hand, if this outbreak is early and severe and there isn't enough vaccine, they'll be criticized for under-preparation."
Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials -- testing to determine safety and dosing -- and assess the virus's threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials.
"There's little doubt we're going to vaccinate people," said Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases, who is leading the government's testing of the vaccine. "Who and when and exactly how -- we have to figure out."
The campaign is haunted by memories of the government's ill-fated 1976 effort to vaccinate against swine flu. The epidemic fizzled, but the vaccine was given to 40 million people and blamed for causing a rare paralyzing disorder known as Guillain-Barré Syndrome.Another wild card will be whether the vaccine will be delivered with an "adjuvant" to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.
"This is an overreaction," said Barbara Loe Fisher of the National Vaccine Information Center, which opposes many vaccine policies. "There is no national security threat here. Why are we operating like this? This is not polio. This is not smallpox." Fears and misinformation about the vaccine are circulating, including inaccurate claims that it will be mandatory.
"I'm very concerned about the dangers of vaccines," said Janice Smith, 58, of Misawaka, Ind., who attended a public hearing Aug. 15, one of a series of meetings the CDC has sponsored to gauge public sentiment about the vaccine. Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say.
To address concerns of pregnant women and parents with young children, some vaccine is being produced without a mercury additive. And because the short-term studies can identify only common, immediate side effects, the CDC will step up monitoring for rarer, serious complications such as Guillain-Barré. "We're putting into place systems that are as good as we can have to identify problems quickly if they do occur," CDC Director Thomas R. Frieden said.
On Friday, officials reported that no "red flags regarding safety" had emerged in the clinical trials. "We are continuing oversight on the quality and safety of the vaccine being produced, and the production process itself," said Jesse Goodman of the FDA. "That's going well so far, but our oversight is continuing." In the meantime, local officials are drafting plans tailored to their communities. The shots in the arms and squirts up the nose will happen in schools, medical offices, hospitals, public health clinics, workplaces, drug stores and at mass vaccination events, possibly including drive-through clinics in parking lots where people would stick their arms out their car windows for a stab.
"It is clearly what we would call an all hands on deck," said James Blumenstock of the Association of State and Territorial Health Officials. "We're not starting from scratch, but we also don't have everything on the shelf that we can just pull off and put in place. It's a full-court press in moving forward to have everything in place when we're ready to go."
In Maryland, officials estimate that 2.9 million people fall into the priority groups for the vaccine; Virginia estimates the number at 2.5 million and the District at 225,000. The national total is about 159 million people.
Public health departments "have suffered from decades of neglect and are now facing a fiscal crisis in many places where they have had to lay staff off, or furlough staff or freeze hiring," Frieden said. "So H1N1 has not come at a particularly good time." Setting priorities for delivering the vaccines will bring other complications. The elderly, usually first in line for flu shots, will not be this time because they seem more resistant to the virus. But they remain a top priority for the seasonal shots. Schools considering giving shots to children are making plans to get permission from parents and have to determine how best to line up anxious, rambunctious students.
Everyone who gets a swine flu shot may need a booster several weeks later, potentially causing mix-ups about who got which shot when. But Frieden and other outside observers expressed confidence that the program would be safe and successful. The federal government has spent close to $2 billion to buy up to 195 million doses of vaccine and adjuvant, including the standard shots and the newer FluMist nasal spray vaccine made by MedImmune of Gaithersburg.
The government is prepared to buy enough to vaccinate every person -- 600 million doses all together -- if the pandemic or demand warrants it. That could increase the cost to $5 billion for the vaccine alone. It would cost at least $9 billion to administer the vaccine to the entire population, according to the Association of State and Territorial Health Officials.
Although five companies are racing to produce as much vaccine as possible, the first batches are not expected for two months, in part because the virus grew at about half the projected rate. Production appears to be increasing, but the first 45 million to 52 million doses -- about a third of what officials were anticipating -- won't be ready until mid-October, with about 20 million doses a week expected after that to continue the campaign through the winter. Experts are uncertain whether they will face a shortage of vaccine because of high demand or will have plenty of vaccine but little interest.
"People's enthusiasm will depend largely on what they see happening around them," Fauci said. "If we get into the fall season and we don't see an explosion of cases, people will be less enthusiastic. If they see a lot of young people and kids getting sick, people will be very enthusiastic about getting vaccinated."
The CDC is formulating a $4.8 million multimedia campaign to encourage people to get vaccinated and help alleviate concerns and confusion, including radio and television public service announcements, print ads, and messages delivered via Twitter, RSS feeds and video podcasts on YouTube. Although the vaccine will be free, providers could charge about $15 to administer it -- a fee that will be covered by Medicare and many health insurance plans.
Experts also worry the swine flu will divert attention from the seasonal flu, which can cause serious illness. Officials will launch the seasonal flu vaccine campaign Sept. 10 -- about a month early in the hopes of vaccinating as many people as possible before the swine flu campaign. The more people who get both vaccines, the less likely the swine flu virus will mingle with one of the others to produce a more dangerous mutant. "We really don't want those ugly viruses mixing together," said Kim Elliott of the Trust for America's Health, a private nonprofit research and advocacy group.
- The Washington Post
PTI 23 August 2009, 08:00am IST
GENEVA: The World Health Organisation is urging the planet to brace for a second wave of the swine flu pandemic as the heavily populated northern hemisphere edges towards the cooler season when flu thrives.
"The WHO is still mobilised and worried," spokesman Gregory Hartl said as the global health watchdog kept an anxious eye on some "mysterious" patterns of illness associated with the new A (H1N1) virus that appeared in April.
Influenza traditionally surges to its peak during the northern autumn and winter. WHO Director General Margaret Chan warned on Friday that there had been second and third waves in previous pandemics. "We cannot say for certain whether the worst is over or the worst is yet to come," Chan said in a videotaped address to a symposium on flu in the Asia-Pacific region. "We need to be prepared for whatever surprises this capricious new virus delivers next," she added.
Some 1,799 people have died since the A(H1N1) was uncovered in Mexico and the United States nearly six months ago, according to the UN health agency. By comparison, an estimated 250,000 to 500,000 people die around the world every year from seasonal flu, and overall the symptoms of the new pandemic virus have proved to be mild in the great majority of known cases. However, it has spread swiftly into 177 countries, proving to be more infectious than seasonal flu and more durable through warmer months.
Through a full season in the southern hemisphere, the pandemic strain gradually became dominant. WHO monitoring showed that it was now on the decline there, except in South Africa, and in some later affected areas of Argentina, Australia and Chile.
Some 182,000 people worldwide are known to have caught swine flu based on laboratory confirmed cases, but the WHO has long advised countries to give up counting; the true number may in the millions, according to some experts. It is also striking those in a more physically fragile phase of life, such as pregnant women or the chronically ill, as well as those who are obese and younger age groups than usual. Many of the most severe cases are among 30 to 50 year -olds.
WHO officials are also mystified at the "most worrying" characteristic of this flu virus, Hartl explained. About 40 percent of the most severe or fatal cases occur in people who are in perfect health, he said. However, he was unable to say how many severe cases had occurred, although they are generally regarded as a small proportion of the outbreak so far.
FACTBOX: How to fight flu spread
So far, no "red flags" seen in H1N1 vaccine
CHICAGO (Reuters) - Clinical trials for the new swine flu vaccine have turned up no red flags, U.S. health officials said on Friday.
First results from studies of the new vaccines in adults and the elderly will be available in mid-September, but so far, the only complaints seem to be a bit of local soreness and redness in the arm at the injection site, they said.
"There are no red flags regarding safety," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health.
Fauci said no side effects were seen 10 to 14 days after the first studies in adults, giving officials the confidence to start trials of the vaccines in children this week.
Two trials are under way in adults for the safety and effectiveness of two doses of the vaccine. The trials, which are also looking at whether one or two vaccinations will be needed, are nearly fully enrolled.
"We expect first dose data somewhere around mid-September if all goes well, and second dose data by mid-October," Fauci said in a telephone news briefing.
Fauci said studies in pregnant women should begin in September, as will studies using an immune system booster called an adjuvant. In all, the vaccines will be tested on nearly 4,600 people.
The U.S. Centers for Disease Control and Prevention said swine flu is still spreading widely across the United States, with 75 percent of serious cases and 60 percent of deaths among people under the age of 49. Alaska and Maine had "widespread" activity.
MORE THAN A MILLION CASES
CDC has confirmed 7,963 hospitalizations and 522 deaths from the pandemic H1N1 flu, said CDC's Dr. Jay Butler. He said there were likely more than a million actual cases, as most patients never get tested.
"It is important to remember that at this time of year we don't normally have influenza," Butler said.
He said the government expected to have 45 million to 52 million swine flu vaccine doses by mid October, when vaccination is expected to begin, and 195 million by the end of the year.
Fauci said even after people are vaccinated they should be aware they are not immediately protected -- the immune response from a vaccine takes about two weeks to develop.
Five companies are making both seasonal and H1N1 flu vaccines for the U.S. market -- AstraZeneca's MedImmune unit, CSL, GlaxoSmithKline Plc, Novartis AG and Sanofi-Aventis SA. Shares of all companies were up slightly in mid-afternoon trading on various exchanges.
Sanofi said on Friday it expects to deliver a bulk supply of H1N1 vaccine to the United States in October. The number of doses will depend on the vaccine's formula, which will be determined in October once clinical trial results are in.
Health officials said they expect an upsurge of flu cases in the autumn, as weather cools and students return to school. U.S. government officials have urged schools and businesses to encourage people to stay home when they are sick, to wash their hands frequently and keep workspaces clean.
"We can't stop the tide of flu any more than we can turn a hurricane in its course or stop the earth shaking during an earthquake, but we can mitigate the effects and help prevent people from becoming severely ill," Butler said.
(Editing by Phil Stewart)
(Additional reporting by Noelle Mennella in Paris)
Saturday, August 22, 2009
By Jason Gale
Aug. 22 (Bloomberg) -- A single standard dose of vaccine may be enough to protect most people against swine flu, according to preliminary research in China that suggests twice as many people as projected could receive the pandemic shot.
An experimental vaccine gave a protective immune response in 85 percent of adults who received an initial dose at the same strength used in seasonal flu shots, Xiaofeng Liang, director of the national immunization program at the Chinese Center for Disease Control and Prevention, told a meeting in Beijing today.
The results provide the earliest indication of the formula that Sanofi-Aventis SA, GlaxoSmithKline Plc and other drugmakers may need to use in making hundreds of millions of doses of vaccine to fight the new H1N1 influenza strain. Authorities in the U.S. and U.K. have predicted two shots would probably be needed, a regimen that would reduce the number of people who could be protected before the northern hemisphere’s winter.
“This is very promising information, and if we are able to get an immunogenic response with one dose as opposed to two doses, this would be a very significant change in our expectations,” Keiji Fukuda, the World Health Organization’s assistant director-general of health security and environment, told the meeting. “Up until now, most of us have been thinking that two doses would be necessary to develop an immunogenic response.”
Health officials are awaiting more data from China, as well as studies overseas, to confirm the results. More results will become available in mid September, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, told reporters yesterday.
“We are waiting anxiously for the immunogenicity data to get a better handle on how well one dose and two doses might work,” Ira Longini, a University of Washington statistician who advises the U.S. government on flu, told the Beijing meeting today. “It may turn out that one is sufficient. Then we could obviously get a lot more vaccine into people much faster. It could essentially double the supply.”
The China data are based on interim results from two of the 10 companies conducting studies in the country on vaccines to fight the new H1N1 virus. The first of the 13,000 test subjects to receive an experimental shot were vaccinated on July 22 and none had a serious adverse reaction to it, Liang said.
Several vaccine types and strengths are being tested in seven provinces of China across four age groups in studies supervised by the country’s CDC, he said.
The trials are assessing the safety and effectiveness of at least three different vaccine strengths in single or two-dose programs, and involving inoculations based on whole and split viral particles, he said. The studies also looked at whether an aluminum-based chemical called an adjuvant boosted the body’s ability to produce infection-fighting antibodies.
Vaccines produced annually for seasonal flu combine 15 micrograms of antigen -- the protein that prompts the production of antibodies -- from each of the three most common influenza strains.
Liang said that a similar dose may be needed to protect most people against the pandemic strain.
“Adolescents and adults had a better response than children and the elderly,” he said. “Taking into consideration the safety, immunogenicity and the cost, a 15-microgram, split vaccine without adjuvant could be used for future vaccination.”
No data is available in children younger than 3, Liang said. A final decision on whether one or two doses will be required to provide protection across all age groups in China won’t be taken until all the data has been collected and analyzed, he said.
Sinovac Biotech, CSL
Sinovac Biotech Co., a Beijing-based company created in 2001 to make immunizations for hepatitis, said last week that its H1N1 vaccine was safe and protected people against the pandemic virus after a single shot. The announcement was based on preliminary results from a study involving 1,614 volunteers.
CSL Ltd., the southern hemisphere’s only flu vaccine maker, expects preliminary results on the first dose of its vaccine next week, Rachel David, a company spokeswoman, said last week. No severe adverse reactions have been observed so far, and the Melbourne-based company plans to submit the data to the Australian government on Sept. 4, she said.
To contact the reporter on this story: Jason Gale in Beijing at email@example.com