Monday, September 28, 2009

Comparative Efficacy of Inactivated and Live Attenuated Influenza Vaccines

Comparative Efficacy of Inactivated and Live Attenuated Influenza Vaccines: "

ORIGINAL ARTICLE

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%.


Full Text PDF

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WHO Director-General Statement following Fifth Meeting of the Emergency Committee

WHO Director-General Statement following Fifth Meeting of the Emergency Committee: "The Emergency Committee held its fifth meeting, via e-mail, concluding on 23 September 2009."


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

Questions and Answers
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."

Update: Questions & Answers: Antiviral Drugs, 2009-2010 Flu Season

Update: Questions & Answers: Antiviral Drugs, 2009-2010 Flu Season: "On September 22, 2009 CDC updated its recommendations for the use of influenza antiviral medicines to provide additional guidance for clinicians in prescribing antiviral medicines for treatment and prevention (chemoprophylaxis) of influenza during the 2009-2010 flu season. These recommendations are intended to help clinicians prioritize use of antiviral drugs for treatment and prevention of influenza."

Brochure: "2009 H1N1 Flu and You"

Brochure: "2009 H1N1 Flu and You": "How does 2009 H1N1 flu spread?
How long can a sick person spread 2009 H1N1 flu to others?
How severe is illness associated with this 2009 H1N1 flu virus?
and more..."

Wednesday, September 23, 2009

Flu Can Raise Chances of Heart Attack - U.S. News & World Report

Flu Can Raise Chances of Heart Attack - U.S. News & World Report: "

Daily Mail

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 »
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H1N1 Clinicians Questions and Answers

H1N1 Clinicians Questions and Answers: "Who is recommended to receive the 2009 H1N1 flu vaccine?
How should providers prioritize among the initial target groups recommended by ACIP?
How will the 2009 H1N1 vaccine flow from manufacturers to providers?
and more..."

Saturday, September 19, 2009

Thursday, September 17, 2009

FDA Approves H1N1 Vaccines

FDA Approves H1N1 Vaccines: "

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.

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Microsoft urges Web learning in case of swine flu - The Associated Press

Microsoft urges Web learning in case of swine flu - The Associated Press: "

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 ...
"

General Questions and Answers on 2009 H1N1 Influenza A Vaccine Safety

General Questions and Answers on 2009 H1N1 Influenza A Vaccine Safety: "Will the 2009 H1N1 influenza vaccines be safe? Are there any side effects to the 2009 H1N1 influenza vaccine? Are there some people who should not receive this vaccine? How will the 2009 H1N1 influenza vaccines be monitored for safety? Will the 2009 H1N1 vaccines that are currently recommended contain adjuvants? More..."

Planning for 2009 H1N1 Influenza: A Preparedness Guide for Small Business

Planning for 2009 H1N1 Influenza: A Preparedness Guide for Small Business: "Small businesses play a key role in protecting employees’ health and safety as well as limiting the impact to the economy and society during an influenza pandemic. Advance planning for pandemic influenza, a novel infectious disease that could occur in varying levels of severity, is critical. Companies that provide critical services, such as power and telecommunications, have a special responsibility to their community to plan for continued operations in a pandemic and should plan accordingly."

Tuesday, September 15, 2009

My one year blogiversary! (My daughter's Blog)

My one year blogiversary!: "
This month marks my one year blogiversary so i decided to share with you readers a little bit more about myself. Enjoy :)

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!
"

WHO Updates International H1N1 Situation

WHO Updates International H1N1 Situation: "In the temperate region of the southern hemisphere (represented by countries such as Chile, Argentina, Australia, New Zealand, and South Africa), influenza activity continues to decrease or return to baseline."

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

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: "We are encouraged by reports that are now emerging from various clinical trials of 2009 H1N1 influenza vaccines, conducted by various vaccine manufacturers."

2009 Influenza (H1N1) monovalent vaccine: Vaccine Provider Agreement Q&A

2009 Influenza (H1N1) monovalent vaccine: Vaccine Provider Agreement Q&A: "The purpose of this document is to answer questions pertaining to the 2009 Influenza (H1N1) monovalent vaccine Vaccine Provider Agreement. The provider agreement is an agreement between providers and public health at the Project Area level and indicates the minimum federal requirements for providers to participate in the H1N1 influenza vaccination effort."

Saturday, September 12, 2009

Measures in school settings

Measures in school settings: "WHO is today issuing advice on measures that can be undertaken in schools to reduce the impact of the H1N1 influenza pandemic. Recommendations draw on recent experiences in several countries as well as studies of the health, economic, and social consequences of school closures. These studies were undertaken by members of a WHO informal network for mathematical modelling of the pandemic."

Opposition to swine flu vaccine seems to be growing worldwide.

Opposition to swine flu vaccine seems to be growing worldwide.: "
Related Articles

Opposition to swine flu vaccine seems to be growing worldwide.


BMJ. 2009;339:b3461


Authors: Kmietowicz Z



PMID: 19710128 [PubMed - indexed for MEDLINE]

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Should healthcare workers have the swine flu vaccine?

Should healthcare workers have the swine flu vaccine?: "
Related Articles

Should healthcare workers have the swine flu vaccine?


BMJ. 2009;339:b3398


Authors: Jordan R, Hayward A



PMID: 19706938 [PubMed - indexed for MEDLINE]

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The CDC’s Recommendations for Influenza A (H1N1) 2009 Vaccine

The CDC’s Recommendations for Influenza A (H1N1) 2009 Vaccine: "

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…

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Online First September 10, 2009, from the New England Journal of Medicine

Online First September 10, 2009, from the New England Journal of Medicine: "

ORIGINAL ARTICLES

Response after One Dose of a Monovalent Influenza A (H1N1) 2009 Vaccine — Preliminary Report

M.E. Greenberg and Others

Full Text PDF Supplementary Material


Trial of Influenza A (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine — Preliminary Report

T.W. Clark and Others

Full Text PDF Supplementary Material


Cross-Reactive Antibody Responses to the 2009 Pandemic H1N1 Influenza Virus

K. Hancock and Others

Full Text PDF Supplementary Material


EDITORIAL

Pandemic Influenza Vaccine Policy — Considering the Early Evidence

K.M. Neuzil

Full Text PDF

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WHO Issues Advice on Measures in School Settings

WHO Issues Advice on Measures in School Settings: "WHO is today issuing advice on measures that can be undertaken in schools to reduce the impact of the H1N1 influenza pandemic. Recommendations draw on recent experiences in several countries as well as studies of the health, economic, and social consequences of school closures."

Questions and Answers: Revised Recommendations for the Use of Influenza Antiviral Drugs

Questions and Answers: Revised Recommendations for the Use of Influenza Antiviral Drugs: "On September 08, 2009 CDC updated its recommendations for the use of influenza antiviral medicines to provide additional guidance for clinicians in prescribing antiviral medicines for treatment and prevention (chemoprophylaxis) of influenza during the upcoming 2009-2010 flu season. These recommendations are intended to help clinicians prioritize use of antiviral drugs for treatment and prevention of influenza."

Sunday, September 06, 2009

WHO supports fair access to influenza A (H1N1) vaccine. An interview with Marie-Paule Kieny

WHO supports fair access to influenza A (H1N1) vaccine. An interview with Marie-Paule Kieny




WHO/L Solberg

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

H1N1 Influenza, Public Health Preparedness, and Health Care Reform: "

PERSPECTIVE

H1N1 Influenza, Public Health Preparedness, and Health Care Reform

N. Lurie


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.


Full Text PDF

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WHO Updates International H1N1 Situation

WHO Updates International H1N1 Situation: "Tropical regions of South and Southeast Asia continue to experience geographically regional or widespread influenza activity (represented by countries such as India, Bangladesh, Myanmar, Thailand, Cambodia, Sri Lanka, and Indonesia). Many countries in the region are reporting increasing or sustained high levels of respiratory disease, and a few (Thailand and Brunei Darussalam) have begun to report a declining trend in the level of respiratory diseases."

CDC Guidance on Helping Child Care and Early Childhood Programs Respond to Influenza during the 2009-2010 Influenza Season

CDC Guidance on Helping Child Care and Early Childhood Programs Respond to Influenza during the 2009-2010 Influenza Season: "Children less than 5 years of age are at increased risk of complications from influenza (flu); the risk is greater among children less than 2 years old. Importantly, infants less than 6 months of age represent a particularly vulnerable group because they are too young to receive the seasonal or 2009 H1N1 influenza vaccine; as a result, individuals responsible for caring for these children constitute a high-priority group for early vaccination."

Assessment of the 2009 Influenza A (H1N1) Outbreak on Selected Countries in the Southern Hemisphere

Assessment of the 2009 Influenza A (H1N1) Outbreak on Selected Countries in the Southern Hemisphere: "On August 9, 2009, the White House charged the Department of Health and Human Services (HHS) in coordination with the Office of the Director for National Intelligence (ODNI) and the Department of State (DoS) to study characteristics and impact of the 2009 Influenza A (H1N1) (refer to as 2009 H1N1) outbreak in the Southern Hemisphere."

Remarks by the President on 2009-H1N1 National Preparedness and Response

Remarks by the President on 2009-H1N1 National Preparedness and Response: "I don't want anybody to be alarmed, but I do want everybody to be prepared. We know that we usually get a second, larger wave of these flu viruses in the fall, and so response plans have been put in place across all levels of government. Our plans and decisions are based on the best scientific information available, and as the situation changes, we will continue to update the public."