The WHO continues to issue regular updates posted on the WHO main page, as well as other advisories linked from that page. Here is the current update:
Influenza A(H1N1) – update 38
25 May 2009 — As of 06:00 GMT, 25 May 2009, 46 countries have officially reported 12 515 cases of influenza A(H1N1) infection, including 91 deaths. Map of the spread of Influenza A(H1N1): number of laboratory confirmed cases and deaths [png 247kb]
The Weekly Epidemiological Record (WER) 22 May 2009, vol. 84, 21 (pp 185–196) includes: Human infection with new influenza A (H1N1) virus: clinical observations from Mexico and other affected countries, May 2009; Leprosy in Yemen: trends in case detection, 1982–2008
WHO released “Recommendations of the Strategic Advisory Group of Experts (SAGE) on Influenza A (H1N1) vaccines, 19 May 2009. Below is full text of a portion of the document”
“After considering the following issues:
1. the need for any recommendation to balance both risks and benefits,
2. the current uncertainty about the severity of influenza A (H1N1) illness,
3. the readiness of vaccine seed strains and reagents for large‐scale vaccine production,
4. the current status of production of seasonal vaccine for the Northern hemisphere, and the risks associated with a premature cessation of seasonal vaccine production, The Working Group considered it premature to recommend that commercial‐scale production of influenza A (H1N1) vaccine should start immediately.
http://www.who.int/csr/resources/publications/swineflu/SAGEH1N1vaccinerecommendation2009_05_19.pdf
WHO released “Summary report of a High-Level Consultation: new influenza A (H1N1) Geneva, 18 May 2009.” Below is full text of a portion of the document:
“CONCLUDING THEMES
The overriding objective is to mitigate the adverse impact of the new influenza A (H1N1) on the health of people and populations.
Facilitating a global response
27. Member States agree to work with the Secretariat to assure ongoing, rapid dissemination of epidemiological information and technical guidance based on scientific evidence concerning the current situation. Monitoring and tracking the global spread and impact of the new influenza A (H1N1) virus is being strengthened. This will support better understanding of the virus’s epidemiology, its virological characteristics, diagnosis, clinical management, outbreak control and strategies, etc.
28. Through its convening power, the Secretariat will continue to facilitate a multilateral and multisectoral response and maximize collaboration between partners.
29. In addition it is providing ongoing technical assistance to countries for epidemic preparedness and response, with a focus on the most vulnerable countries.
Ensuring equity in access to medicines and vaccines
30. Given the potential impact of pandemic influenza on populations in low-income countries, where other medical conditions are widespread, concern remains about access to antiviral medicines and vaccines.
31. The Secretariat has dispatched antiviral medicines from its emergency stockpile to 72 countries so as to accelerate their availability where they are most needed.
32. WHO collaborating centres are developing seed stocks of virus for vaccine production. Close links are being maintained with the pharmaceutical industry and potential financiers to ensure an adequate global manufacturing capacity, and funding for production and distribution of new influenza A (H1N1) vaccine and other relevant medicines.
Building public health capacity
33. Building institutional and technical capacity in low-income countries, especially in laboratory services, is needed if the world is to mount an effective response. Securing finance for building this capacity – as a key element of health systems strengthening – will be essential.
Moving from Phase 5 to Phase 6
34. The current process is based purely on geographical spread and not on severity of disease. Several Member States spoke in favour of giving the Director-General greater flexibility in the progression between different phases.
http://www.who.int/csr/resources/publications/swineflu/High_Level_Consultation_18_May_2009.pdf
HHS Secretary Kathleen Sebelius announced that “the department will take important steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A ( H1N1),” and that HHS “is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.” Secretary Sebelius said, “Preparation and planning are critical to keep Americans safe in the face of a potential pandemic. Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed.”
HHS said the funds will be used to place new orders on existing contracts with companies that hold U.S. licenses for flu vaccines. With these orders, they will produce a bulk supply of vaccine antigen and adjuvant. HHS noted that having both antigen and adjuvant on hand provides maximum flexibility in a future immunization program, “if a program is recommended. For example, if needed these ingredients could be used in vaccine to help protect health providers and other members of the critical workforce, as recommended by the National Strategy for Pandemic Influenza.”
The funds will also support manufacturers which will also “prepare pilot lots of potential vaccine for use in clinical studies to determine the proper dose for a vaccine, determine if adjuvants are appropriate and ensure a vaccine is safe and effective. The U.S. government will share as much information as possible from the results of these clinical studies with the World Health Organization and the global community so that other countries can benefit from the U.S. efforts to determine dosage, safety and effectiveness.”
Global measles elimination was discussed by WHO’s Executive Board last week. The report developed for the meeting “summarizes the progress and challenges towards achieving the regional measles elimination goals and reducing global measles deaths by 90% between 2000-10. The report also highlights the programme of work initiated by WHO to examine issues relating to the feasibility of a global measles elimination goal including reviewing the biological aspects and cost-effectiveness of such a goal.”
GAVI said the International Finance Facility for Immunisation (IFFIm) “has raised more than US$ 2 billion dollars on the international capital markets so far to support life-saving immunisation programmes through the GAVI Alliance.” IFFIm board chairman Alan Gillespie, at a meeting on innovative financing in Geneva, noted that “…there is a strong demand among individual and institutional investors for ethical investments….this is just the beginning and we believe we can raise another US$ 2 billion. The demand is there.” IFFIm is backed by the United Kingdom, France, Italy, Spain, Sweden, Norway and South Africa, which have pledged to contribute US$5.3 billion to IFFIm over 20 years. IFFIm “converts these long-term government pledges into immediately available cash by issuing bonds on the capital markets” which carry a triple-A rating from the three major rating agencies…making it an attractive and ethical investment opportunity to both individual and institutional investors alike. The World Bank acts as financial adviser and Treasury Manager to IFFIm.
http://www.gavialliance.org/media_centre/press_releases/2009_05_19_IFFIm_ethical_investment.php
The GAVI Alliance used the 62nd World Health Assembly in Geneva to highlight the commitments to immunisation, despite the financial crisis, by “more and more of the world’s poorest countries” through their contributions “towards the cost of life-saving vaccines…” GAVI CEO Julian Lob-Levyt presented awards to a number of countries (listed below) and noted that twenty seven developing countries now contribute to vaccine costs through the GAVI Alliance, up from just six in 2007. In total, these co-payments amounted to more than US$ 17 million in 2008, or 15% of the respective cost to GAVI.
Countries receiving awards included: Benin, Bolivia, Burundi, Cameroon, Ghana, Liberia, Madagascar, Malawi, Rwanda, Solomon Islands, Tanzania, Yemen and Zambia. GAVI said that “through its unique co-financing policy, (it) encourages recipient governments to contribute between 10 and 30 US cents per dose, depending on their ability to pay. http://www.gavialliance.org/media_centre/press_releases/2009_05_19_WHA_cofinancing.php
WHO released the first progress report on the health-related Millennium Development Goals (MDGs) in its World Health Statistics 2009. Deaths of children aged under five years have dropped by 27% globally since 1990: an estimated 9 million children aged under five years died in 2007, significantly fewer than the 12.5 million estimated to have died in 1990, the baseline year against which progress towards the goals is measured. “However, in many African countries and in low-income countries generally, progress has been insufficient to reach the MDG target, that aims for a two thirds reduction in child mortality.” Dr Ties Boerma, Director of WHO’s Department of Health Statistics and Informatics, said, “The decline in the death toll of children under five illustrates what can be achieved by strengthening health systems and scaling up interventions, such as insecticide-treated mosquito nets for malaria and oral rehydration therapy for diarrhoea, increased access to vaccines and improved water and sanitation in developing countries…at the mid-way point, the analysis shows encouraging signs of progress, but there needs to be more effort to strengthen health systems in countries affected by high levels of HIV/AIDS, economic hardship or conflict. Moreover, there is a need to pay greater attention to the poorest groups within countries where progress is often the slowest and child mortality rates remain high.”
Dr Boerma continued, “Areas where there has been little or no movement are notably maternal and newborn health. An estimated 37% of deaths among children aged under five occurs in the first month of life, and most of them in the first week of life. While the data are patchy and incomplete, it appears that the regions with the least progress are those where levels of maternal mortality are the highest.” World Health Statistics 2009 is an annual report based on more than 100 health indicators collected from WHO’s 193 Member States. These indicators provide a snapshot of global health trends. However, the data have some limitations. Among other findings, the report reveals:
– An estimated 1.2 billion people are affected by neglected tropical diseases. In 2007, 546 million people were treated to prevent the parasitic disease lymphatic filariasis (also known as elephantiasis), which causes enlargement of parts of the body.
– The availability of essential medicines at public health facilities is often poor and prices remain high, even for generic medicine.
– There are now more than 3 million people in developing countries receiving antiretroviral therapy, which proves that complex treatment for chronic disease is possible in low-income settings.
– Adolescent pregnancy rates remain high. Globally, there were 48 births for every 1000 women aged 15–19 years in 2006, a small decline from 51 per 1000 in the year 2000.
– Out of every 100 deaths worldwide, 51 are due to noncommunicable conditions; 34 due to communicable, maternal or nutritional conditions; and 14 due to injuries.
– Changes in population age structures, risk factors and disease patterns are resulting in increases in the proportion of deaths due to noncommunicable diseases such as heart disease, stroke, cancers and road traffic accidents. Many developing countries have to cope with a double burden of both infectious and noncommunicable diseases that is overwhelming their health-care systems. Action needs to be taken now to implement preventive interventions including reductions in tobacco use, overweight and obesity, and high blood pressure.
http://www.who.int/mediacentre/news/notes/2009/millennium_development_goals_20090521/en/index.html
Journal of Infectious Diseases
15 June 2009 Volume 199, Number 12
http://www.journals.uchicago.edu/toc/jid/current
EDITORIAL COMMENTARY
Avian Influenza A (H5N1) Virus and 2 Fundamental Questions
Sylvie Briand and Keiji Fukuda, Global Influenza Programme, Health and Environment Cluster, World Health Organization, Geneva, Switzerland
“Since 1997, when the avian influenza A (H5N1) virus infected 18 residents of Hong Kong, Special Administrative Region, China, 6 of whom died, 2 questions have been of paramount importance related to this virus. How many other individuals are infected? How are individuals becoming infected?…[discussion of three studies cited below…]
Risk Factors for Human Illness with Avian Influenza A (H5N1) Virus Infection in China
Lei Zhou, Qiaohong Liao, Libo Dong, Yang Huai, Tian Bai, Nijuan Xiang, Yuelong Shu, Wei Liu, Shiwen Wang, Pengzhe Qin, Min Wang, Xuesen Xing, Jun Lv, Ray Y. Chen, Zijian Feng, Weizhong Yang, Timothy M. Uyeki, and Hongjie Yu
Ecologic Risk Factor Investigation of Clusters of Avian Influenza A (H5N1) Virus Infection in Thailand
Thanawat Tiensin, Syed Sayeem Uddin Ahmed, Suvichai Rojanasthien, Thaweesak Songserm, Parntep Ratanakorn, Kridsada Chaichoun, Wantanee Kalpravidh, Surapong Wongkasemjit, Tuangthong Patchimasiri, Karoon Chanachai, Weerapong Thanapongtham, Suwit Chotinan, Arjan Stegeman, and Mirjam Nielen
Risk Factors Associated with Subclinical Human Infection with Avian Influenza A (H5N1) Virus—Cambodia, 2006
Sirenda Vong, Sowath Ly, Maria D. Van Kerkhove, Jenna Achenbach, Davun Holl, Philippe Buchy, San Sorn, Heng Seng, Timothy M. Uyeki, Touch Sok, and Jacqueline M. Katz
The Lancet Infectious Disease
Jun 2009 Volume 9 Number 6 Pages 331 – 392
http://www.thelancet.com/journals/laninf/issue/current
Leading Edge
Putting influenza A H1N1 in its place
The Lancet Infectious Diseases
Writing in London’s Guardian newspaper on May 6, the columnist Simon Jenkins rails against how the dangers of the current influenza A H1N1 outbreak have been exaggerated by the mass media and scientists. He calls for an inquiry into “this fiasco” and, paraphrasing Voltaire, suggests shooting the occasional virologist and perhaps an editor too, “to encourage the others”. Although nominations of colleagues to take a bullet to restore the damaged reputation of our professions may be many, Jenkins seems to have confused scientific uncertainty with hype.
The Lancet Infectious Disease
Jun 2009 Volume 9 Number 6 Pages 331 – 392
http://www.thelancet.com/journals/laninf/issue/current
Review
Clinician’s guide to human papillomavirus immunology: knowns and unknowns
Mark H Einstein, John T Schiller, Raphael P Viscidi, Howard D Strickler, Pierre Coursaget, Tina Tan, Neal Halsey, David Jenkins
Summary
Oncogenic human papillomavirus (HPV) is a common genital infection that has the potential to develop into cervical cancer in some women. This Review summarises current knowledge on the mechanisms of host immunity that help prevent and control HPV infection and the viral factors that exist to avoid immune surveillance. Although most women clear the infection within a few months, the virus induces a shift towards immune tolerance that can facilitate persistence and permit tumorigenesis. Mechanisms used by HPV to avoid immune surveillance and control include infecting only the basal layer of the cervical epithelium, limiting expression of viral proteins until later stages of epithelial differentiation, undergoing non-lytic replication, and downregulating the expression of important receptors on cells of the innate immune system. Furthermore, HPV suppresses the expression of several proinflammatory proteins that are crucial in clearing infection and activating the cytotoxic T lymphocytes involved in killing virus-infected cells. Interestingly, neutralising antibodies, although of uncertain effectiveness in preventing infection or reinfection after natural exposure (prior infection), are highly protective after immunisation with HPV virus-like-particle-based vaccines. Understanding what is known and unknown about the interaction between the immune system and HPV is important in the assessment of the potential contribution of prophylactic vaccination in reducing the incidence of cervical cancer. However, despite our growing understanding, many aspects of the interactions between HPV and the host immune system remain unknown, and this Review draws attention to several of these unresolved issues and their implications.
The Lancet Infectious Disease
Jun 2009 Volume 9 Number 6 Pages 331 – 392
http://www.thelancet.com/journals/laninf/issue/current
Media Watch
Humanity’s burden: a global history of malaria
Talha Burki
The third work by Jim Webb (Colby College, Maine, USA), Humanity’s Burden: A Global History of Malaria begins by establishing malaria’s longevity: “a primordial companion of our distant protohuman ancestors and an even earlier companion of the chimpanzees from which we branched off six or seven million years ago”.
Nature
Volume 459 Number 7245 pp299-472 21 May 2009
http://www.nature.com/nature/journal/v459/n7245/
Commentary
Pandemics: good hygiene is not enough
“The US government is doing well to communicate uncertainty over swine flu. It must also help the public to visualize what a bad pandemic might be like, says Peter M. Sandman.”
Essay
Pandemics: avoiding the mistakes of 1918
“As bodies piled up, the United States’ response to the ‘Spanish flu’ was to tell the public that there was no cause for alarm. The authority figures who glossed over the truth lost their credibility, says John M. Barry.”
New England Journal of Medicine
Volume 360 — May 21, 2009 — Number 21
http://content.nejm.org/current.shtml
Perspective
Digital Disease Detection — Harnessing the Web for Public Health Surveillance
J. S. Brownstein, C. C. Freifeld, and L. C. Madoff
The Internet has become a critical medium for clinicians, public health practitioners, and laypeople seeking health information. Data about diseases and outbreaks are disseminated not only through online announcements by government agencies but also through informal channels, ranging from press reports to blogs to chat rooms to analyses of Web searches (see Digital Resources for Disease Detection). Collectively, these sources provide a view of global health that is fundamentally different from that yielded by the disease reporting of the traditional public health infrastructure.1
Influenza A (H1N1) Virus, 2009 — Online Monitoring
J. S. Brownstein, C. C. Freifeld, and L. C. Madoff
PLoS Medicine
(Accessed 25 May 2009)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results
Published 19 May 2009
Hedging against Antiviral Resistance during the Next Influenza Pandemic Using Small Stockpiles of an Alternative Chemotherapy
Joseph T. Wu, Gabriel M. Leung, Marc Lipsitch, Ben S. Cooper, Steven Riley
Science
22 May 2009 Vol 324, Issue 5930, Pages 973-1104
http://www.sciencemag.org/current.dtl
Editorial
Epidemic Science in Real Time
Harvey V. Fineberg1 and Mary Elizabeth Wilson2
Few situations more dramatically illustrate the salience of science to policy than an epidemic. The relevant science takes place rapidly and continually, in the laboratory, clinic, and community. In facing the current swine flu (H1N1 influenza) outbreak, the world has benefited from research investment over many years, as well as from preparedness exercises and planning in many countries. The global public health enterprise has been tempered by the outbreak of severe acute respiratory syndrome (SARS) in 2002–2003, the ongoing threat of highly pathogenic avian flu, and concerns over bioterrorism. Researchers and other experts are now able to make vital contributions in real time. By conducting the right science and communicating expert judgment, scientists can enable policies to be adjusted appropriately as an epidemic scenario unfolds.
Harvey V. Fineberg is president of the Institute of Medicine.
Mary Elizabeth Wilson is associate professor of Global Health and Population at the Harvard School of Public Health and associate clinical professor at Harvard Medical School, Boston, MA.
Vaccine
Volume 27, Issue 28, Pages 3681-3800 (8 June 2009)
http://www.sciencedirect.com/science/journal/0264410X
Challenges in the evaluation and licensing of new pneumococcal vaccines, 7–8 July 2008, Ottawa, Canada
Pages 3681-3688
I. Feavers, I. Knezevic, M. Powell, E. Griffiths and on behalf of the WHO Consultation on Serological Criteria for Evaluation and Licensing of New Pneumococcal Vaccines
Abstract
The introduction of seven valent pneumococcal conjugate vaccine (7vPnC) into immunization programmes has led to a significant reduction in invasive disease due to Streptococcus pneumoniae. New conjugate pneumococcal vaccine formulations containing additional serotypes are at advanced stages of clinical development and are expected to be available in the near future. There are also a number of on-going initiatives to facilitate the introduction of pneumococcal conjugate vaccines into the immunization programmes of developing countries. These initiatives are dependent upon the vaccines being satisfactorily licensed and subsequently pre-qualified by the WHO for use by UN agencies.
Recommendations for the production and control of pneumococcal conjugate vaccines were established by WHO in 2003 and have served as a basis for national requirements for the evaluation and licensing of these products. Much progress has been made since that time and a consultation held in Ottawa, Canada, in July 2008 aimed to provide regulators and manufacturers with further guidance on the criteria for evaluating and licensing of new pneumococcal conjugate vaccines taking account of recent developments.
The principal conclusion of the meeting was that the current WHO recommendations, in which the demonstration of immunological non-inferiority to the licensed 7vPnC vaccine is proposed as the main basis for approval, continue to provide a solid basis for the evaluation of pneumococcal conjugate vaccines and may be referred to when assessing new vaccines for licensure and pre-qualification. Uncertainties regarding serological criteria for assessing the efficacy of new conjugate vaccines against invasive pneumococcal disease were discussed in detail and proposals made for handling complex data.
In particular, it was emphasized that all relevant immunological data should be taken into account when comparing new pneumococcal conjugate vaccines with licensed 7vPnC vaccine. These include the measurement of the total amount of anticapsular IgG as well as the demonstration of functionality of vaccine-induced antibodies, by verifying their ability to opsonize and promote the killing of pneumococcal serotypes, and the demonstration of immunological priming. It was agreed that new information on assay performance and on the effectiveness of currently licensed 7vPnC vaccine, as assessed in routine mass immunization programmes, should both be included in any update of the WHO recommendations. A detailed meeting report is available at the WHO web site for biologicals: http://www.who.int
Vaccine
Volume 27, Issue 28, Pages 3681-3800 (8 June 2009)
http://www.sciencedirect.com/science/journal/0264410X
Why polio has not been eradicated in India despite many remedial interventions?
Pages 3700-3703
Yash Paul
Abstract
Oral polio vaccine has reduced the incidence of polio in India and many states have been polio free for a long time while occasional polio cases are occurring in some states. On the other hand more than 96% of polio cases being reported in India are occurring in Uttar Pradesh and Bihar. The current polio scenario indicates that oral polio vaccines cannot eradicate polio from Uttar Pradesh and Bihar because some children from these two states show poor response to OPV. There is an urgent need for re-appraisal of polio eradication strategy.
The WHO continues to issue regular updates posted on the WHO main page, as well as other advisories linked from that page. Here is the current update:
Influenza A(H1N1) – update 31 17 May 2009
— As of 06:00 GMT, 17 May 2009, 39 countries have officially reported 8480 cases of influenza A(H1N1) infection.
Mexico has reported 2895 laboratory confirmed human cases of infection, including 66 deaths. The United States has reported 4714 laboratory confirmed human cases, including four deaths. Canada has reported 496 laboratory confirmed human cases, including one death. Costa Rica has reported nine laboratory confirmed human cases, including one death.
The following countries have reported laboratory confirmed cases with no deaths – Argentina (1), Australia (1), Austria (1), Belgium (4), Brazil (8), China (5), Colombia (11), Cuba (3), Denmark (1), Ecuador (1), El Salvador (4), Finland (2), France (14), Germany (14), Guatemala (3), India (1), Ireland (1), Israel (7), Italy (9), Japan (7), Malaysia (2), Netherlands (3), New Zealand (9), Norway (2), Panama (54), Peru (1), Poland (1), Portugal (1), Republic of Korea (3), Spain (103), Sweden (3), Switzerland (1), Thailand (2), Turkey (1), and the United Kingdom (82).
WHO is not recommending travel restrictions related to the outbreak of the influenza A(H1N1) virus. Individuals who are ill should delay travel plans and returning travelers who fall ill should seek appropriate medical care. These recommendations are prudent measures which can limit the spread of many communicable diseases, including influenza.
http://www.who.int/csr/don/2009_05_17/en/index.html
Assessing the severity of an influenza pandemic is a WHO discussion of various factors influencing influenza pandemic severity:
http://www.who.int/csr/disease/swineflu/assess/disease_swineflu_assess_20090511/en/index.html
The WHO posted an update titled “Status of candidate vaccine virus development for the current Influenza A(H1N1) virus”
Publication date: 8 May 2009:
For the current influenza A(H1N1) virus, WHO Collaborating Centres for influenza (WHO CCs), Essential Regulatory Laboratories (ERLs) and other institutions are developing candidate vaccine viruses under the coordination of WHO1. Once a vaccine virus is available, WHO will announce the availability on its public website2.
Candidate vaccine viruses using reverse genetics technology are being developed by:
– WHO CC in the Centers for Disease Control and Prevention (CDC), Atlanta USA, from A/California/4/2009(H1N1)swl. Expected availability end of May.
– ERL in the National Institute for Biological Standards and Control (NIBSC), UK, from A/California/7/2009(H1N1)swl and A/England/195/2009 (H1N1)swl. Expected availability end of May.
– ERL in the Centre for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) USA, from A/California/4/2009(H1N1)swl and A/Texas/5/2009(H1N1)swl. Expected availability not yet known.
– WHO CC at the St. Jude Children’s Research Hospital, Memphis USA, from A/California/4/2009(H1N1)swl, A/New York/20/2009(H1N1)swl and A/Ohio/7/2009 (H1N1)swl. Expected availability not yet known.
– WHO CC at National Institute of Infectious Diseases (NIID), Japan, from A/California/4/2009(H1N1)swl and A/California/7/2009(H1N1)swl. Expected availability not yet known.
– CSL Limited, Australia, from A/California/4/2009(H1N1)swl and A/California/7/2009(H1N1)swl. Expected availability not yet known.
Candidate vaccine viruses using classical reassortment technology are being developed by:
– ERL NIBSC, UK, from A/California/7/2009(H1N1)swl, an egg virus isolate. Expected availability not yet known.
– New York Medical College, USA, from A/California/7/2009(H1N1)swl. Expected availability not yet known.
– CSL Limited, Australia, from A/California/7/2009(H1N1)swl. Expected availability not yet known.
Development of vaccine potency reagents for inactivated vaccines against Influenza A(H1N1) is planned in:
– ERL NIBSC, UK.
– ERL CBER FDA, USA. Email
– ERL, Therapeutic Goods Administration (TGA), Australia.
– ERL NIID, Japan.
Wild type viruses have been/ are being sent to vaccine manufacturers on request including:
– Baxter, CSL Limited, GlaxoSmithKline Biologicals, MedImmune, Microgen, Nobilon International, Novartis, Omninvest Vaccines, Pasteur, Solvay and Vivaldi.
1 WHO coordinates WHO CCs, National Influenza Centers and ERLs. This Network is monitoring the evolution of influenza viruses, both seasonal and those with potential to cause a pandemic, including the current influenza A(H1N1). The Network also provides recommendations and updates on diagnostics, monitors the susceptibility of emerging influenza viruses to antiviral drugs, and selects, develops and distributes vaccine viruses.
2 http://www.who.int/csr/disease/swineflu/en/index.html
http://www.who.int/csr/resources/publications/swineflu/vaccine_virus_development/en/index.html
The 62nd Session of the World Health Assembly is underway in Geneva during 18-22 May 2009. At this session, the Health Assembly will discuss a number of public health issues, including:
– pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits;
– implementation of the International Health Regulations;
– primary health care, including health system strengthening;
– social determinants of health; and
– monitoring the achievement of the health-related Millennium Development Goals.
The supporting document for the agenda item on “pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits” includes a discussion of the proposed WHO A/(H5N1) vaccine stockpile. Document available at:
The Weekly Epidemiological Record (WER) for 15 May 2009, vol. 84, 20 (pp 173–184) includes: New influenza A(H1N1) virus infections: global surveillance summary, May 2009; The Paediatric Bacterial Meningitis Surveillance Network in WHO’s African Region, 2001–2008
GlaxoSmithKline said it has received orders from several governments “aiming to stockpile a new candidate A (H1N1) adjuvanted influenza vaccine as a precautionary measure.” GSK said it manufacture the new vaccine, once virus seed is made available by the WHO. The first doses of the vaccine are expected to be available four to six months later, subject to regulatory approval. The vaccine “will comprise antigen of the recently isolated A (H1N1) influenza strain and also contain GSK’s proprietary adjuvant system AS03” and will require regulatory approval. GSK summarized orders to date for the new vaccine, in addition to discussions with the CDC in the U.S., to include:
– “Supplying the UK Government with 60 million doses of the candidate A (H1N1) adjuvanted influenza vaccine,
– “The French Government intend to purchase 50 million doses of the candidate A (H1N1) influenza vaccine.
– “The Government of Belgium intend to purchase 12.6 million doses of the candidate A (H1N1) influenza vaccine in order to stockpile and to protect, when needed, the total Belgian population.
– “An agreement with the Government of Finland to supply 5.3 million doses of H1N1 antigen, which is expected to be used in conjunction with the government’s existing stockpile of GSK’s adjuvant system.”
GSK noted that it “is committed to addressing the needs of developing countries with use of this candidate adjuvanted vaccine,” and said it “will convert its intended donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine once production begins.” GSK also said that “in the future, as capacity increases, GSK will supply the candidate A (H1N1) adjuvanted influenza vaccine to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility.”
http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10054.htm
HIV Vaccine Awareness Day, 18 May 2009; Statement of Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health
“On this 12th annual HIV Vaccine Awareness Day, we reaffirm our commitment to the research needed to develop a safe and effective HIV vaccine.
People continue to become infected with HIV at an alarming rate. An estimated 2.7 million new HIV infections occurred worldwide in 2007 alone. Here in the United States, about 56,000 new HIV infections occur annually — a figure that has remained fairly consistent for more than a decade. Although antiretroviral medicines have enabled individuals infected with HIV to live longer, healthier lives, no one with HIV has ever been truly cured of the infection, and people with HIV continue to die of AIDS-related diseases in unacceptably high numbers in rich and poor countries alike.
Historically, vaccines have eliminated or greatly reduced the burden of many viral diseases, including smallpox, polio, measles, and yellow fever. HIV, however, presents unique and significant scientific obstacles that have made vaccine development particularly daunting. Most importantly, people are unable to mount an effective immune system response that clears HIV infection. This is likely because of the ability of HIV to rapidly invade and hide in host cells, and elude detection by normal immune system responses; its extraordinary capacity to mutate and evolve; and its destruction or disabling of critical immune system cells. While extremely rare, some individuals do develop antibodies that effectively neutralize HIV, but investigational vaccines so far have not induced these antibodies in a large number of people.
Recognizing these challenges and working to build upon disappointing clinical trial outcomes, NIAID in 2008 hosted a scientific summit where we committed to placing a greater emphasis on the fundamental research needed to unlock the mysteries of the human immune system and HIV infection. Since that time, we have launched several basic research-focused initiatives and studies that are beginning to produce interesting insights that may help us design future HIV vaccines. At the same time, we continue to test promising vaccine candidates in clinical trials when scientifically appropriate.
Although vaccines will continue to play a prominent role in Naiad’s broad and multifaceted HIV prevention research agenda, other new prevention approaches are in advanced testing. These include microbicide gels or creams that can be applied prior to sexual intercourse and pre-exposure prophylaxis — the use of antiretroviral medicines in people who are not infected with HIV but who are at high risk for infection. Another important prevention concept is universal, voluntary HIV testing and treatment for those who test positive. One recent model suggests that such a test-and-treat program could reduce HIV infection rates by 95 percent within 10 years. NIAID is evaluating critical research questions that underpin the validity of this voluntary approach.
Our hope is that the development of an HIV vaccine and other advances in HIV prevention research will become part of a comprehensive HIV prevention toolkit that will markedly decrease new infections, even as we continue to expand our efforts to find a cure for HIV/AIDS.
Finally, today we specifically wish to thank the thousands of volunteers, scientists, community members and health professionals who have participated in HIV vaccine research and who continue to support and participate in this extremely important research effort. With your help and continued dedication, we will win the fight against HIV.”
New England Journal of Medicine
Volume 360 — May 14, 2009 — Number 20
http://content.nejm.org/current.shtml
Globalized Clinical Trials and Informed Consent
G. J. Annas
[Initial article text per NEJM convention]
The increasing globalization of clinical research trials calls for more effective ethical and legal rules to protect both research subjects and scientific integrity.1 Some observers noted more than a decade ago that research was being conducted in developing countries without concern for adherence to the international ethical principles for human-subjects research contained in the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (see Codes Relied on by the Second Circuit).2 The situation has not improved. For example, late last year, the Food and Drug Administration (FDA) decided that research studies submitted to it for review need no longer be . . .
Vaccine
Volume 27, Issue 24, Pages 3127-3238 (21 May 2009)
http://www.sciencedirect.com/science/journal/0264410X
National immunization advisory committees of the World Health Organization’s European Region
Pages 3131-3136
Margie C. Andreae, Kara Switalski, Leah Abraham, Gary L. Freed
Abstract
This study sought to understand the prevalence, structure and decision-making process of national immunization advisory committees (IACs) among the 53 member countries of the World Health Organization (WHO)’s European region. Of the 47 countries responding to the electronically administered questionnaire, 37 (72%) have an IAC. The majority of committees have a legislative basis while just over half have formal terms of reference. Fewer than half have experts in health economics. The vast majority of countries do not allow the public to attend committee meetings nor distribute publicly the minutes of their meetings. Countries should partner with financial experts early in the process of immunization policy decision-making and should examine their policies regarding conflicts of interest and public access to meetings, as financial strategy and public trust are essential to the successful implementation of new vaccines.
Vaccine
Volume 27, Issue 24, Pages 3127-3238 (21 May 2009)
http://www.sciencedirect.com/science/journal/0264410X
Age, revaccination, and tolerance effects on pneumococcal vaccination strategies in the elderly: A cost-effectiveness analysis
Pages 3159-3164
Kenneth J. Smith, Richard K. Zimmerman, Mary Patricia Nowalk, Mark S. Roberts
Abstract
Optimal pneumococcal polysaccharide vaccination (PPV) policy is unknown for cohorts aged ≥65 years. Using a Markov model, we estimated the cost-effectiveness of single- and multiple-dose PPV strategies in 65-, 75-, and 80-year-old cohorts. PPV at age 65 cost $26,100 per QALY (quality adjusted life years) gained. Vaccination at ages 75 and 80 cost $71,300–75,800 per QALY; revaccination strategies cost more. When prior vaccination and loss of vaccine effectiveness due to tolerance are assumed, cost-effectiveness ratios increase substantially. Single-dose PPV is worth considering in patients aged 65–80 from clinical and economic standpoints. Revaccination strategies for the elderly are less cost-effective, particularly when prior vaccination and vaccine tolerance are considered.
Vaccine
Volume 27, Issue 24, Pages 3127-3238 (21 May 2009)
http://www.sciencedirect.com/science/journal/0264410X
Human papillomavirus (HPV) vaccine availability, recommendations, cost, and policies among health departments in seven Appalachian states
Pages 3195-3200
Mira L. Katz, Paul L. Reiter, Brenda C. Kluhsman, Stephenie Kennedy, Sharon Dwyer, Nancy Schoenberg, Andy Johnson, Gretchen Ely, Karen A. Roberto, Eugene J. Lengerich, Pamela Brown, Electra D. Paskett, Mark Dignan
Abstract
Telephone interviews of health department personnel in six states and review of an immunization database from one state were conducted to assess human papillomavirus (HPV) vaccine availability, recommendations, cost, policies, and educational materials in health departments in seven Appalachian states. Most (99.1%) health departments (n = 234) reported receiving patient requests for the HPV vaccine, and only two (1%) health departments reported that they did not provide the vaccine for patients. HPV vaccine supply was reported to not meet the demand in 10.5% (24/228) of health departments due to high costs. Level (state, region, county) at which policy about the HPV vaccine was determined, vaccine recommendations, costs, and available educational materials varied among states. This study documented variation in vaccine availability, recommendations, cost, policies, and educational materials in Appalachian health departments that could significantly affect vaccine distribution. Findings highlight the need for more comprehensive and consistent policies that maximize accessibility of the HPV vaccine to women, especially those in underserved areas.
Vaccine
Volume 27, Issue 24, Pages 3127-3238 (21 May 2009)
http://www.sciencedirect.com/science/journal/0264410X
Development of the Rubella Vaccine and Vaccination Strategy in Japan
Pages 3232-3233
Kohji Ueda
Abstract
The development of the rubella vaccine and vaccination strategy in Japan was unique. Five rubella vaccines used in Japan were licensed, and the rubella vaccination program to schoolgirls was started in 1977. The measles-mumps-rubella vaccination to children, which was started in 1989, was terminated in 1993 due to the adverse effect of aseptic meningitis. In 1994, rubella vaccination to children, using the monovalent rubella vaccine, was restarted. Then, a new vaccination program, vaccinating twice by using the combined measles and rubella vaccine, was started in 2006. The increase in the rate of vaccination leads us to hope for the “Elimination of Rubella and Congenital Rubella Syndrome in 2012”.
The WHO continues to issue regular updates posted on the WHO main page, as well as other advisories linked from that page. Here are current updates:
Influenza A(H1N1) – update 25 – 11 May 2009
As of 06:00 GMT, 11 May 2009, 30 countries have officially reported 4694 cases of influenza A(H1N1) infection.
Mexico has reported 1626 laboratory confirmed human cases of infection, including 48 deaths. The United States has reported 2532 laboratory confirmed human cases, including three deaths. Canada has reported 284 laboratory confirmed human cases, including one death. Costa Rica has reported eight laboratory confirmed human cases, including one death.
The following countries have reported laboratory confirmed cases with no deaths – Argentina (1), Australia (1), Austria (1), Brazil (8), China (2, comprising 1 in China, Hong Kong Special Administrative Region, and 1 in mainland China), Colombia (3), Denmark (1), El Salvador (4), France (13), Germany (11), Guatemala (1), Ireland (1), Israel (7), Italy (9), Japan (4), Netherlands (3), New Zealand (7), Norway (2), Panama (15), Poland (1), Portugal (1), Republic of Korea (3), Spain (95), Sweden (2), Switzerland (1) and the United Kingdom (47).
WHO is not recommending travel restrictions related to the outbreak of the influenza A(H1N1) virus.
Individuals who are ill should delay travel plans and returning travelers who fall ill should seek appropriate medical care. These recommendations are prudent measures which can limit the spread of many communicable diseases, including influenza.
Further information on the situation will be available on the WHO web site on a regular basis.
WHO Director General Address to the ASEAN+3 Health Ministers’ Special Meeting on Influenza A(H1N1), Bangkok, Thailand; (Via videoconference); 8 May 2009
World is better prepared for influenza pandemic
Dr Margaret Chan
Director-General of the World Health Organization
[Full text]
Honourable ministers, distinguished participants, ladies and gentlemen, Thank you for convening this special meeting of health ministers, and thank you for giving me an opportunity to address you.
Above all, thank you for your diligence all these years in tracking the H5N1 virus in humans and animals, in reporting and treating so many cases, and in dealing with so many tragic deaths.
For five long years, you have kept this avian virus under watch, and largely under control.
As we know today, the virus with the greatest pandemic potential, the H1N1 virus, has sprung up from another source, on another side of the world.
But H5N1 taught the world to expect a pandemic, and to plan for this event.
The world is better prepared for an influenza pandemic than at any time in history, thanks, in part, to your vigilance and diligence.
Years of alert and expectation mean that most countries now have preparedness plans. Vaccine manufacturing capacity has increased sharply. Large stocks of antiviral drugs have been produced and procured.
Right now, treatment courses from the WHO stockpile are being shipped to more than 70 countries in the developing world.
We are, right now, gaining experience in the use of non-medical interventions, such as social distancing, to delay spread of the H1N1 virus.
WHO and its regional offices have tested their alert and response plans, also in operational exercises. We are prepared.
In addition, we have the backing of the greatly strengthened International Health Regulations.
This is a time of great uncertainty for all countries, and great pressure on ministers and ministries of health. The only certain thing that can be said about influenza viruses is that their behaviour is entirely unpredictable. No one can say how the current situation will evolve.
Countries will, quite rightly, want to do everything possible to prevent the arrival of the virus or, once in a country, to delay its further spread and thus flatten the epidemiological peak.
At the same time, it is important for countries to refrain from introducing economically and socially disruptive measures that lack solid scientific backing and bring no clear public health benefit.
The rational use of travel- and trade-related measures is always wise. It is all the more wise at a time of severe economic downturn.
Ladies and gentlemen,
On this occasion, let me make two additional requests.
First, do not drop the ball on monitoring H5N1. This virus is endemic in poultry in parts of the region. We have no idea how H5N1 will behave under the pressure of a pandemic.
Second, H5N1 has conditioned the public to equate an influenza pandemic with very severe disease and high mortality. Such a disease pattern is by no means inevitable during a pandemic. On the contrary, it is exceptional.
From past experience, ASEAN+3 countries know what it means to be at centre-stage during the outbreak of a new disease. We must battle misperceptions with the facts, and respond to the disease with the facts. I know you will help me on this front as well.
The decision to declare an influenza pandemic will fall on my shoulders. I can assure you, I will take this decision with utmost care and responsibility.
Thank you.
http://www.who.int/dg/speeches/2009/asean_influenza_ah1n1_20090508/en/index.html
The Weekly Epidemiological Record (WER) for 8 May 2009, vol. 84, 19 (pp 161–172) includes: Outbreak news – Yellow fever, Republic of the Congo; Dracunculiasis eradication – global surveillance summary, 2008; New influenza A(H1N1) virus – update
The MMWR for May 8, 2009/ Vol. 58 / No. 17, includes:
– Update: Novel Influenza A (H1N1) Virus Infections — Worldwide, May 6, 2009
– Outbreak of Swine-Origin Influenza A (H1N1) Virus Infection — Mexico, March–April 2009
– Swine-Origin Influenza A (H1N1) Virus Infections in a School — New York City, April 2009
Sanofi Pasteur announced today that the U.S. Food and Drug Administration (FDA) has licensed its new influenza vaccine manufacturing facility located in Swiftwater, Pennsylvania, which “will incorporate the latest technology in egg-based vaccine production as part of the company’s commitment to produce the largest number of doses of vaccine in the shortest time frame to address the threat of seasonal and pandemic influenza.” Sanofi said the new , US$150 million, 140,000 square-foot (13,000 square-meter) vaccine facility is “part of its commitment to support public health and to protect individuals against both seasonal and pandemic influenza.” The new facility will produce 100 million doses when operating at full capacity. Wayne Pisano, President and CEO of sanofi Pasteur, said, “Sanofi Pasteur is assessing its capabilities to support public health efforts should the WHO and national health authorities request that influenza vaccine manufacturers start supplying vaccine to protect against the new influenza A (H1N1) virus. With the licensure of this new influenza vaccine production facility, Sanofi Pasteur now has additional flexibility to produce seasonal influenza vaccine and to respond to requests from public health authorities to develop an A (H1N1) vaccine.”
(PRNewswire-FirstCall, 6 May 2009)
Wyeth Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted priority review to the company’s Biologic License Application (BLA) for Prevnar 13*, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein), which was submitted on March 31. Based on this designation, Wyeth said it expects a regulatory decision within six months. Wyeth is seeking an indication in the U.S. for Prevnar 13 for the prevention of invasive pneumococcal disease (IPD) and otitis media caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein), described by Wyeth as “the current global standard in PD prevention in infants and young children.” The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease. Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals, commented, “Since its launch in 2000, our 7-valent pneumococcal vaccine, Prevnar, has significantly reduced the incidence of pneumococcal disease among infants and young children in the United States. Recently, however, disease due to pneumococcal serotypes not found in Prevnar, particularly serotype 19A, have increased in prevalence in many regions of the world, and are a significant public health concern. Prevnar 13, which builds on the scientific foundation of Prevnar, is designed to provide protection against the 13 most prevalent serotypes associated with pneumococcal disease.”
(PRNewswire-FirstCall, 7 May 2009)
The Bill & Melinda Gates Foundation announced 81 grants of US$100,000 each “to explore bold and largely unproven ways to improve health in developing countries” under its Grand Challenges Explorations initiative. The foundation said grants were awarded to researchers in 17 countries. The first round of 104 Grand Challenges Explorations grants was announced in October 2008. Dr. Tachi Yamada, president of the Gates Foundation’s Global Health Program, said “Investments in global health research are already paying big dividends. An incredible number of new vaccines, drugs, and other tools are becoming available to improve health in developing countries. Grand Challenges Explorations is our way to help inspire the bold ideas that could one day help transform global health.”
In the area of “more efficient and effective vaccines,” grants went to:
– Lucia Lopalco of the San Raffaele Scientific Institute in Italy will seek ways to generate “self-targeting antibodies” that attack a receptor protein on human immune cells – potentially blocking the HIV virus from entering cells and preventing HIV infection.
– Fasséli Coulibaly at Monash University in Australia will test whether protein crystals produced by insect viruses can be used as a new way to deliver vaccines. These “MicroCube” protein particles are stable, could be used against multiple diseases, and may not require refrigeration.
– Mei Wu at Massachusetts General Hospital and Harvard Medical School in the U.S. will explore whether illuminating skin with a targeted laser before administering a vaccine can enhance immune response.
The Lancet
May 09, 2009 Volume 373 Number 9675 Pages 1577 – 1658
http://www.thelancet.com/journals/lancet/issue/current
Editorial
Pre-empting a pandemic—fact or fiction?
The Lancet
Preview
Human-to-human transmission of influenza A (H1N1) has been confirmed and on April 29, WHO raised the influenza pandemic alert to phase 5. Panic has ensued in some regions: the culling of hundreds of thousands of pigs has been ordered in Egypt; pork trade has been restricted; facemasks have been widely distributed; airports are using thermal-based scanners to screen passengers. These measures have little, or no, evidence for their implementation. There is uncertainty regarding travel advisories; WHO does not advise restriction of regular travel or closure of borders, whereas recommendations in the USA, UK, Canada, and Australia are to avoid all non-essential travel to Mexico.king programme, which needs further research and assessment.
The Lancet
May 09, 2009 Volume 373 Number 9675 Pages 1577 – 1658
http://www.thelancet.com/journals/lancet/issue/current
Editorial
What has the Gates Foundation done for global health?
The Lancet
Preview
The answer to this question is: a great deal, but…The massive boost to global health funding that the Bill & Melinda Gates Foundation has given since its inception in 1994 is astonishing. The Foundation’s current expenditure of around US$3 billion annually has challenged the world to think big and to be more ambitious about what can be done to save lives in low-income settings. The Gates Foundation has added renewed dynamism, credibility, and attractiveness to global health. In particular, the Foundation inaugurated an important new era of scientific commitment to global health predicaments.
Health Policy
The Bill & Melinda Gates Foundation’s grant-making programme for global health
David McCoy, Gayatri Kembhavi, Jinesh Patel, Akish Luintel
Original Text
Summary
The Bill & Melinda Gates Foundation is a major contributor to global health; its influence on international health policy and the design of global health programmes and initiatives is profound. Although the foundation’s contribution to global health generally receives acclaim, fairly little is known about its grant-making programme. We undertook an analysis of 1094 global health grants awarded between January, 1998, and December, 2007. We found that the total value of these grants was US$8·95 billion, of which $5·82 billion (65%) was shared by only 20 organisations. Nevertheless, a wide range of global health organisations, such as WHO, the GAVI Alliance, the World Bank, the Global Fund to Fight AIDS, Tuberculosis and Malaria, prominent universities, and non-governmental organisations received grants. $3·62 billion (40% of all funding) was given to supranational organisations. Of the remaining amount, 82% went to recipients based in the USA. Just over a third ($3·27 billion) of funding was allocated to research and development (mainly for vaccines and microbicides), or to basic science research. The findings of this report raise several questions about the foundation’s global health grant-making programme, which needs further research and assessment.
New England Journal of Medicine
Volume 360 — May 7, 2009 — Number 19
http://content.nejm.org/current.shtml
Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases
Saad B. Omer, M.B., B.S., Ph.D., M.P.H., Daniel A. Salmon, Ph.D., M.P.H., Walter A. Orenstein, M.D., M. Patricia deHart, Sc.D., and Neal Halsey, M.D.
ABSTRACT
Vaccines are among the most effective prevention tools available to clinicians. However, the success of an immunization program depends on high rates of acceptance and coverage. There is evidence of an increase in vaccine refusal in the United States and of geographic clustering of refusals that results in outbreaks. Children with exemptions from school immunization requirements (a measure of vaccine refusal) are at increased risk for measles and pertussis and can infect others who are too young to be vaccinated, cannot be vaccinated for medical reasons, or were vaccinated but did not have a sufficient immunologic response. Clinicians can play a crucial role in parental decision making. Health care providers are cited as the most frequent source of immunization information by parents, including parents of unvaccinated children. Although some clinicians have discontinued or have considered discontinuing their provider relationship with patients who refuse vaccines, the American Academy of Pediatrics Committee on Bioethics advises against this and recommends that clinicians address vaccine refusal by respectfully listening to parental concerns and discussing the risks of nonvaccination.
Influenza A(H1N1) – update 13 – 4 May 2009 –
As of 06:00 GMT, 4 May 2009, 20 countries have officially reported 985 cases of influenza A (H1N1) infection.
Mexico has reported 590 laboratory confirmed human cases of infection, including 25 deaths. The higher number of cases from Mexico reflects ongoing testing of previously collected specimens. The United States has reported 226 laboratory confirmed human cases, including one death.
The following countries have reported laboratory confirmed cases with no deaths – Austria (1), Canada (85), China, Hong Kong Special Administrative Region (1), Costa Rica (1), Colombia (1), Denmark (1), El Salvador (2), France (2), Germany (8), Ireland (1), Israel (3), Italy (1), Netherlands (1), New Zealand (4), Republic of Korea (1), Spain (40), Switzerland (1) and the United Kingdom (15).
There is no risk of infection from this virus from consumption of well-cooked pork and pork products.
It is considered prudent for people who are ill to delay international travel and for people developing symptoms following international travel to seek medical attention, in line with guidance from national authorities. Individuals are advised to wash hands thoroughly with soap and water on a regular basis and should seek medical attention if they develop any symptoms of influenza-like illness.
WHO advises no restriction of regular travel or closure of borders.
Further information on the situation will be available on the WHO website on a regular basis.
No rationale for travel restrictions
1 May 2009 — WHO is not recommending travel restrictions related to the outbreak of the influenza A(H1N1) virus. Today, international travel moves rapidly, with large numbers of individuals visiting various parts of the world. Limiting travel and imposing travel restrictions would have very little effect on stopping the virus from spreading, but would be highly disruptive to the global community.
Influenza A(H1N1) has already been confirmed in many parts of the world. The focus now is on minimizing the impact of the virus through the rapid identification of cases and providing patients with appropriate medical care, rather than on stopping its spread internationally. Furthermore, although identifying the signs and symptoms of influenza in travellers can be an effective monitoring technique, it is not effective in reducing the spread of influenza as the virus can be transmitted from person to person before the onset of symptoms. Scientific research based on mathematical modelling indicates that restricting travel will be of limited or no benefit in stopping the spread of disease. Historical records of previous influenza pandemics, as well as experience with SARS, have validated this point.
Travellers can protect themselves and others by following simple recommendations related to travel aimed at preventing the spread of infection. Individuals who are ill should delay travel plans and returning travellers who fall ill should seek appropriate medical care. These recommendations are prudent measures which can limit the spread of many communicable diseases and not only influenza A(H1N1).
http://www.who.int/csr/disease/swineflu/guidance/public_health/travel_advice/en/index.html
WHO published an FAQ addressing vaccine strategies and A(H1N1). Some of the FAQs are presented below with a link to the full set below
Vaccines for the new influenza A(H1N1)
2 May 2009
Is an effective vaccine already available against the new influenza A(H1N1) virus?
No, but work is already under way to develop such a vaccine. Influenza vaccines generally contain a dead or weakened form of a circulating virus. The vaccine prepares the body’s immune system to defend against a true infection. For the vaccine to protect as well as possible, the virus in it should match the circulating “wild-type” virus relatively closely. Since this H1N1 virus is new, there is no vaccine currently available made with this particular virus. Making a completely new influenza vaccine can take five to six months.
What implications does the declaration of a pandemic have on influenza vaccine production?
Declaration by WHO of phase 6 of pandemic alert does not by itself automatically translate into a request for vaccine manufacturers to immediately stop production of seasonal influenza vaccine and to start production of a pandemic vaccine. Since seasonal influenza can also cause severe disease, WHO will take several important considerations such as the epidemiology and the severity of the disease when deciding when to formally make recommendations on this matter. In the meantime, WHO will continue to interact very closely with regulatory and other agencies and influenza vaccine manufacturers.
How important will influenza A(H1N1) vaccines be for reducing pandemic disease?
Vaccines are one of the most valuable ways to protect people during influenza epidemics and pandemics. Other measures include anti-viral drugs, social distancing and personal hygiene.
Will currently available seasonal vaccine confer protection against influenza A(H1N1)?
The best scientific evidence available today is incomplete but suggests that seasonal vaccines will confer little or no protection against influenza A(H1N1).
What is WHO doing to facilitate production of influenza A(H1N1) vaccines?
As soon as the first human cases of new influenza A(H1N1) infection became known to WHO, the WHO Collaborating Center in Atlanta (The Centers for Disease Control and Prevention (CDC) in the United States of America) took immediate action and began the work to develop candidate vaccine viruses. WHO also initiated consultations with vaccine manufacturers worldwide to facilitate the availability of all necessary material to start production of influenza A(H1N1) vaccine. In parallel, WHO is working with national regulatory authorities to ensure that the new influenza A(H1N1) vaccine will meet all safety criteria and be made available as soon as possible.
Why is WHO not asking vaccine manufacturers to switch production from seasonal vaccine to an influenza A(H1N1) vaccine yet?
WHO has not recommended stopping production of seasonal influenza vaccine because this seasonal influenza causes 3 million to 5 million cases of severe illness each year, and kills from 250 000 to 500 000 people. Continued immunization against seasonal influenza is therefore important. Moreover, stopping seasonal vaccine production immediately would not allow a pandemic vaccine to be made quicker. At this time, WHO is liaising closely with vaccine manufacturers so large-scale vaccine production can start as soon as indicated.
Is it possible that manufacturers produce both seasonal and pandemic vaccines at the same time?
There are several potential options which must be considered based on all available evidence.
What is the process for developing a pandemic vaccine? Has a vaccine strain been identified, and if so by whom?
A vaccine for the Influenza A(H1N1) virus will be produced using licensed influenza vaccine processes in which the vaccine viruses are grown either in eggs or cells. Candidate vaccine strains have been identified and prepared by the WHO Collaborating Center in Atlanta (The Centers for Disease Control and Prevention (CDC) in the United States of America). These strains have now been received by the other WHO Collaborating Centers which have also started preparation of vaccine candidate viruses. Once developed, these strains will be distributed to all interested manufacturers on request. Availability is anticipated by mid-May.
How quickly will influenza A(H1N1) vaccines be available?
The first doses of Influenza A(H1N1) vaccine could be available in five to six months from identification of the pandemic strain. The regulatory approval will be conducted in parallel with the manufacturing process. Regulatory authorities have put into place expedited processes that do not compromise on the quality and safety of the vaccine. Delays in production could result from poor growth of the virus strain used to make the vaccine.
The MMWR weekly May 1, 2009 / Vol. 58 / No. 16 includes:
– Update: Swine-Origin Influenza A (H1N1) Virus — United States and Other Countries
– Update: Drug Susceptibility of Swine-Origin Influenza A (H1N1) Viruses, April 2009
– Update: Swine Influenza A (H1N1) Infections — California and Texas, April 2009
The Pharmaceutical Research and Manufacturers of America (PhRMA) noted that Rx Response has been put on Alert Status “as concerns grow over the health threat posed by outbreaks of swine flu in the United States.” Rx Response, “an unprecedented partnership created to help ensure the continued flow of medicines to patients in a severe public health emergency,” was developed more than 2 years ago in response to Hurricane Katrina and the threat of pandemic influenza.” Alert Status “means that Rx Response members are now closely monitoring developing information regarding influenza cases detected in the United States and are working with local, state and federal health authorities to help ensure the continued efficient functioning of the nation’s pharmaceutical supply chain.” Rx Response members include:
– American Hospital Association (AHA)
– American Red Cross
– Biotechnology Industry Organization (BIO)
– Generic Pharmaceutical Association (GPhA)
– Healthcare Distribution Management Association (HDMA)
– National Association of Chain Drug Stores (NACDS)
– National Community Pharmacists Association (NCPA)
– Pharmaceutical Research and Manufacturers of America (PhRMA)
Rx Response “is a single point of contact for the entire pharmaceutical supply system and relies on a robust network that allows federal and state emergency management officials to communicate with Rx Response regarding pharmaceutical needs and other issues which may impact the supply system. The communications are actively monitored by all segments of the pharmaceutical supply system to ensure the fastest possible resolution.”
The U.S. Food and Drug Administration and the Federal Trade Commission released an alert to the public “to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus.” The agencies are also “advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.” Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs, said, “Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families. In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.” FTC Chairman Jon Leibowitz commented, “The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies. The FTC will act swiftly against companies that resort to deceptive advertising.”
http://www.fda.gov/bbs/topics/NEWS/2009/NEW02007.html
The Lancet
May 02, 2009 Volume 373 Number 9674 Pages 1495 – 1576
http://www.thelancet.com/journals/lancet/issue/current
Immunisation timing: the protective layer in vaccine coverage
Jim P Buttery, Stephen M Graham
Vaccination coverage has long been a traditional measure of the success and efficiency of immunisation programmes. Encouragingly, crude coverage rates, measured as three doses of diphtheria, tetanus, and pertussis vaccine by 1 year of age, have risen in most surveys over the past two decades. However, populations at greatest risk of vaccine-preventable disease are least likely to be immunised. Timely immunisation is crucial for direct protective effects during infancy and early childhood, when disease and mortality are highest.
The Lancet
May 02, 2009 Volume 373 Number 9674 Pages 1495 – 1576
http://www.thelancet.com/journals/lancet/issue/current
A global fund for the health MDGs?
Giorgio Cometto, Gorik Ooms, Ann Starrs, Paul Zeitz
The world is off track to achieve the health-related targets of the Millennium Development Goals (MDGs) by 2015.1 Maternal mortality has stagnated for two decades,2 child mortality is not declining fast enough,3 HIV/AIDS still infects people faster than the pace of antiretroviral treatment roll-out,4 and inequalities are widening within and across countries.5 Addressing these crises will require increased funding and more efficient spending. The next Board meetings of the Global Fund to Fight AIDS, Tuberculosis and Malaria and the GAVI Alliance, scheduled for May and June, respectively, present an opportunity to tackle these issues.
The Lancet
May 02, 2009 Volume 373 Number 9674 Pages 1495 – 1576
http://www.thelancet.com/journals/lancet/issue/current
The African Network for Drugs and Diagnostics Innovation
Tom Mboya-Okeyo, Robert G Ridley, Solomon Nwaka
Africa bears the greatest burden of disease in the world today,1 but concrete research and development mechanisms to address this inequity within the continent are lacking. There have been several recent calls through international and regional fora for increased investment in health research and development in developing countries,2,3 These reports show that the international community is committed to supporting research activities in developing countries, especially in Africa. However, to ensure sustainability, the leadership to implement local agendas for research and development must come from within.
The Lancet
May 02, 2009 Volume 373 Number 9674 Pages 1495 – 1576
http://www.thelancet.com/journals/lancet/issue/current
Timing of children’s vaccinations in 45 low-income and middle-income countries: an analysis of survey data
Andrew Clark, Colin Sanderson
Background
Vaccinations are often delayed until well after the recommended ages, leaving many children exposed for longer than they should be. We estimated vaccination coverage at different ages, and delays in administration, in 45 low-income and middle-income countries.
Methods
We used data for 217 706 children from Demographic and Health Surveys between 1996 and 2005 (median 2002), which provided data for vaccination of children on the basis of events recorded on vaccination cards and interviews with mothers, with imputation of missing values and survival analysis. We devised an index combining coverage and delay.
Findings
For vaccinated children, the median of the median delays in the 45 countries was 2·3 weeks (IQR 1·4—4·6) for bacille Calmette-Guérin (BCG); 2·4 weeks (1·2—3·3) for diphtheria, tetanus, and pertussis (DTP1); 2·7 weeks (1·7—3·1) for measles-containing vaccine (MCV1); and 6·2 weeks (3·5—8·5) for DTP3. However, in the 12 countries with the longest delays for each vaccination, at least 25% of the children vaccinated were more than 10 weeks late for BCG, 8 weeks for DTP1, 11 weeks for MCV1, and 19 weeks for DTP3. Variation within countries was substantial: the median of the IQRs in the 45 countries for delay in DTP3 was 10·9 weeks, 7·9 weeks for MCV1, 5·4 weeks for BCG, and 5·3 weeks for DTP1. The median of the national coverage rates for DTP1 increased from 57% in children aged 12 weeks to 88% at 12 months, and for DTP3 from 65% at 12 months to 76% at 3 years.
Interpretation
The timeliness of children’s vaccination varies widely between and particularly within countries, and published yearly estimates of national coverage do not capture these variations. Delayed vaccination could have important implications for the effect of new and established vaccines on the burden of disease.
Funding
WHO’s Initiative for Vaccine Research.
vaccines and global health :: ethics and policy 
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