Worldwide Vaccine Output Falls Short

According to a recent Wall Street Journal article, less than half of the swine-flu vaccine expected to be shipped to doctors, hospitals and clinics in the U.S. this month has been shipped so far.

Officials say the delays are occurring around the globe, and are due to a series of manufacturing difficulties, as vaccine makers scramble to fill vast orders using an old technology that requires growing virus in chicken eggs. It usually takes about six to nine months to produce vaccine once a flu strain has been identified.

The total amount of vaccine that has been shipped is far below the government's most recent estimate that by the end of this month, about 28 million to 30 million doses would be ready. However, the number of doses shipped is steadily increasing.

"We are nowhere near where we thought we'd be by now," CDC Director Thomas Frieden said Friday. "We share the frustration of people who have waited in line or called a number or checked a Web site and haven't been able to find a place to get vaccinated."

He declined to provide specific projections for delivery of more doses but said he expected the supply to be "much more widespread" within the next several weeks. "We have confidence that ultimately there will be enough vaccine for everybody who wants to be vaccinated to get vaccinated," he said.

The U.S. government has invested more than $2 billion to develop newer, faster methods of vaccine production, but these aren't yet ready for response to a pandemic. The delays raise questions as to how well the vaccine supply will be able to stem the current wave of infection.

The U.S. has purchased H1N1 vaccines from Sanofi-Aventis SA, Novartis AG, CSL Ltd., GlaxoSmithKline PLC and Medimmune, which is a unit of Astra Zeneca PLC.

The process has been slower than usually seen with seasonal vaccines. Viruses for both vaccines go through a purification process after being grown in eggs.

One problem is that Glaxo, which has contracted to provide 7.6 million doses of vaccine to the U.S., has yet to get Food and Drug Administration approval for its vaccine. A Glaxo spokeswoman said she couldn't speculate on the timing of approval. The FDA declined to comment.

Some suppliers have also experienced "brief interruptions in operations" of new production lines started up to handle the huge demand.

Nasal spray however has been produced much more quickly, since its production does not take as long as that of the flu shot. However, it is not recommended for pregnant women, children under 2 years, adults over 50 years, and indivduals with weakened immune systems or respiratory disease (among others). These are the people who have been hit the hardest by the pandemic.

http://online.wsj.com/article/SB125623425595101755.html

Indonesia to Reopen NAMRU-2

New Indonesian Health Minister Endang Rahayu Sedyaningsih said on Friday that the controversial United States Naval Medical Research Unit-2 shut down by previous health minister Siti Fadillah Supari for alleged non-scientific activities, including espionage, would reopen with a new name and under civilian control.

Endang, speaking after the first meeting of the new cabinet, said the research unit, also known as Namru, had been shut down because of its military links, but civilian-to-civilian cooperation with the United States in the field of biomedical research would continue.

“The Namru military presence no longer exists,” Endang said, adding that the unit had been renamed the Indonesia-United States Center for Medical Research, or IUS.

Endang, whom Siti demoted in 2008 for taking bird flu samples out of the country without permission, said the IUS would focus on the development of vaccines and diagnostic tools and the identification of viruses and bacteria.

Separately, Patra M. Zen, chairman of the Indonesian Legal Aid Foundation, urged President Susilo Bambang Yudhoyono to establish an independent team to investigate Namru, and similar operations, before allowing the Health Ministry to establish new cooperation agreements.

He said the government should not approve any cooperation agreement that did not offer sufficient benefits to Indonesia.

The Medical Emergency Rescue Committee (MER-C), a Islamic nongovernmental organization that has been linked to hardline groups and individuals, also went on the offensive during a news conference on Friday. MER-C representative Jose Rizal said that though the new agreement involved civilians, the government should still be wary. “We have to be alert of such agreements because [it] could be a new NAMRU with a different face.” Jose said.

“If they already have the virus, they can make the vaccine. The vaccine can be sold at a very high price,” Jose said. “The virus can even be used to create a new disease, just to make a vaccine that can be sold.”

Jose urged the government to monitor such operations and involve more local researchers, adding it would be best if the government halted all foreign involvement. “We want the virus samples not to fall into the wrong hands. If they were misused, like for creating biological weapons, then it would be a dangerous for us and the world,” Jose said.

View the entire article in the Jakarta Globe at http://thejakartaglobe.com/news/health-ministry-to-reopen-namru/337343

USAID Launches Emerging Pandemic Threats Program

The United States Agency for International Development (USAID) is launching an Emerging Pandemic Threats (EPT) program that builds on the successes of the Agency's long-standing programs in disease surveillance, training, and outbreak response, particularly those addressing avian and pandemic influenza. The focus of the EPT program is to pre-empt or combat, at their source, newly emerging diseases of animal origin that could threaten human health.

USAID's EPT program will focus resources on detecting dangerous pathogens at an early stage, building appropriate laboratory capacity to support surveillance, responding in an appropriate and timely manner, strengthening national and local response capacities, and educating at-risk populations on how to prevent exposure to these dangerous pathogens. The EPT program is being managed by USAID with technical support from the U.S. Centers for Disease Control and Prevention and the United States Department of Agriculture.

The EPT program is a comprehensive and interconnected intervention package that will be implemented through five projects, each requiring specific technical skill sets, but which will work harmoniously together to provide seamless technical assistance and expertise in the field. The five projects in the EPT program are:

• PREDICT: USAID has awarded a five-year cooperative agreement to a constellation of leading experts in wildlife surveillance including University of California Davis School of Veterinary Medicine, Wildlife Conservation Society, Wildlife Trust, The Smithsonian Institute, and Global Viral Forecasting, Inc. to monitor for and increase the local capacity in "geographic hot spots" to identify the emergence of new infectious diseases in high-risk wildlife such as bats, rodents, and non-human primates that could pose a major threat to human health.

• RESPOND: USAID has awarded a five-year cooperative agreement to a coalition of technical resources including Development Alternatives, Inc., University of Minnesota, Tufts University, Training and Resources Group, and Ecology and Environment, Inc. to strengthen the human capacity of countries to identify and respond to outbreaks of newly emergent diseases in a timely and sustainable manner. This project will focus on the development of outbreak investigation and response training that merges animal and human health dynamics into a comprehensive capacity for disease detection and control.

• IDENTIFY: USAID is working with the U.N. World Health Organization (WHO), U.N. Food and Agriculture Organization (FAO), and the World Organization for Animal Health (OIE) through existing grants to support the development of laboratory networks and strengthened diagnostic capacities in the "geographic hot spots" for new emergent diseases.

• PREVENT: USAID has awarded a five-year cooperative agreement to The Academy for Educational Development and Global Viral Forecasting, Inc. to build an effective behavior change communication response to zoonotic diseases, support efforts to characterize "high-risk" practices that increase the potential for new disease threats from wildlife or wildlife products to spread and infect people, and formulate behavior change and/or communication strategies and interventions that meet the challenges posed by the emergence of a new infectious disease.

• PREPARE: USAID has awarded a three-year cooperative agreement to International Medical Corps to provide technical support for simulations and field tests of national, regional, and local pandemic preparedness plans to ensure that countries have the capacity to implement response plans effectively during pandemic events.

For more information about USAID, please visit www.usaid.gov.

Swine Flu's Collateral Health Benefits in Bolivia

According to a recent Time magazine article, massive campaigns by Bolivia's public-health officials to contain the spread of the new flu virus has millions of Bolivians, especially school children, washing their hands much more frequently than before.

Public-health experts now say the increase in hand-washing across the country may have had some collateral benefits, not only in helping to reduce H1N1 infections, but also the spread of other common diseases in Bolivia. "We see a steady 10% to 15% drop in the rate of incidence of acute diarrheal diseases in all age groups, compared with last year's numbers at this time," says Dr. René Lenis, Bolivia's director of epidemiology, referring to data collected on the number of weekly cases of diarrheal disease reported in medical centers nationwide in 2008 and 2009.

Often, though, the problem is not just about good habits or bad ones but about access to clean water or the ability to afford soap. In Bolivia, 25% of the country still doesn't have access to water in the home. Health officials recognize that every citizen must have a sink to wash their hands in before they can expect significant reduction in disease. But when more than half the population is already living with some sort of bacterial or parasitic stomach infection, it's crucial to encourage those who can wash their hands to do so.

Some are still wary of the short-term data on Bolivia's descending rates of diarrheal disease; it remains to be seen whether the trend will hold up. But the findings "make a lot of sense, because behavior change like increased hand-washing happens quicker when there is a perceived threat," says Therese Dooley, a senior advisor for UNICEF's Water, Sanitation and Hygiene (WASH) project.

Bolivia's challenge now is to maintain the good numbers. The last time Bolivia witnessed a plummet in diarrheal-disease rates was during the cholera outbreak of 1992 and 1993, when better personal-hygiene habits led to a reduction in the spread of infection. But as the threat of the disease died down, so too did people's standards of cleanliness.

View the entire article at http://www.time.com/time/health/article/0,8599,1931223,00.html

Updated H1N1 Global Spread

According to the World Health Organization, as of Friday, nearly 5,000 people have died from swine flu infections since the A(H1N1) virus was uncovered in April.

The death toll marked an increase of about 265 over the 4,735 deaths reported to the WHO a week ago. Most of the fatal cases -- 3,539 -- have been recorded in North and South America, the UN health agency said in its latest update on the flu pandemic.

Iceland, Sudan, and Trinidad and Tobago reported their first fatal cases over the past week. Mongolia, Rwanda, and Sao Tome and Principe also recorded pandemic influenza cases for the first time, as the virus continued to spread. However, A(H1N1) influenza was declining in tropical areas of the world, with the exception of Cuba and Colombia.

There was also no significant pandemic related activity over the past week in temperate areas of the southern hemisphere, the WHO said.

Meanwhile respiratory disease activity continues to spread and increase in intensity in the northern hemisphere, mainly in North America.

Updated Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings

The Centers for Disease Control and Prevention (CDC) has issued updated recommendations on both administrative controls and engineering controls to eliminate sources of infection and prevent transmission of pandemic H1N1 within healthcare facilities.

Revisions from earlier guidance include: criteria for identification of suspected influenza patients; recommended time away from work for healthcare personnel; changes to isolation precautions based on tasks and anticipated exposures; expansion of information on interventions using a hierarchy of controls approach; changes in recommendations on the routine use of gowns and eye protection; and changes to guidance on use of respiratory protection.

According to the report, to ensure a comprehensive infection control strategy, healthcare facilities will want to:

• Vaccinate their workforce with seasonal and 2009 H1N1 vaccines.
• Keep sick workers at home.
• Enforce respiratory hygiene and cough etiquette.
• Enhance hand hygiene compliance.
• Establish facility access control measures and triage procedures.
• Manage visitor access and movement within the facility.
• Control patient placement and transport.
• Apply isolation precautions.

The report goes into more detail about how exactly institutions can go about ensuring that these controls are implemented.

View the entire report at http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm

Avian Flu Found in Dead Crows in Cote D'Ivoire

The United Nations Food and Agriculture Organization (FAO) in Cote d'Ivoire has confirmed that tests on several dead crows found in the yard of the Blaise Pascal High School in the commercial capital, Abidjan, have yielded positive results for H5N1 avian influenza virus.

The crows were found dead in the school yard on October 6th, and according to Dr. Mel Eg Emmanuel, the representative of the FAO in Cote d'Ivoire, emergency measures had been taken including the closure of the high school and disinfection of the entire contaminated area.

He said a team of the National Institute for Public Health had been monitoring 25 people who had been exposed to the carcass of the birds, including 17 who had actually been in contact with the carcass.

WHO H1N1 Situation Update 70, October 16, 2009

The most recent WHO situation update discusses current distribution and spread trends of pandemic H1N1 around the globe. As usual, surveillance information may be an underestimation, as most countries have stopped counting and investigating all individual cases.

The update also highlights three articles of interest published this week in the peer reviewed literature, that reported three different series of seriously ill pandemic influenza patients in Canada, Mexico, Australia, and New Zealand. Several important observations were made including:

• A significant portion of patients with severe disease requiring intensive care had no predisposing conditions. The numbers are not directly comparable as the studies categorized conditions differently but nearly 1/3 of ICU patients in Australia and New Zealand had no predisposing conditions. 98% of ICU cases in Canada had a comorbid condition, which in this report included hypertension, smoking, and substance abuse, but only 30% had comorbid conditions that were considered "major". In Mexico, 84% of critical patients had an underlying condition, which in the report included hypertension, ever having smoked, and hyperlipidemia, conditions that are not considered risk factors for severe influenza outcomes. All three groups were impressed by the number of severe cases occurring in previously healthy individuals.

• The researchers in Australia and New Zealand reaffirmed that infants under the age of 1 year have the highest risk of developing severe illness. The average age of ICU patients was 32, 40, and 44 years in Canada, Australia/New Zealand, and Mexico respectively.

• The study from Australia and New Zealand estimated that the demand for ICU beds due to viral pneumonia during the pandemic was as much higher than in previous influenza seasons. The Canadian study reported that intensive care capacity in Winnipeg, Manitoba, was "seriously challenged" at the peak of the outbreak with full occupancy of all regional ICU beds.

View Update 70 at http://www.who.int/csr/don/2009_10_16/en/index.html

Immunity to 2009 pandemic H1N1 among older populations

A recent study from Spain found that people born before 1950 show some immunity against 2009 pandemic influenza A H1N1. This is because H1N1 subtype viruses, similar to the 2009 pandemic H1N1 strain, have been circulating since the Spanish influenza pandemic in 1918.

So far, H1N1 subtype viruses have not dramatically changed in their genetic makeup over time, so individuals who were previously exposed to these strains will have more immunity to the 2009 H1N1 virus than younger people who have never been exposed to an H1N1 virus.

However, as might be expected, when older persons who are susceptible to H1N1 viruses (this is a minority of older people) become infected with 2009 pandemic H1N1, they seem to have a higher likelihood of needing hospital care and a higher case fatality rate than any other age group.

View the entire article at http://www.eurosurveillance.org/images/dynamic/EE/V14N39/art19344.pdf

Low- and Middle-Income Nations to Receive Pandemic H1N1 Vaccine as Early as November

From today's BBC News:
"The WHO has long stressed the need for developing countries to get access to some doses of the vaccine if the global campaign against the virus is to be effective.

On Monday the WHO's head of vaccine research, Marie-Paule Kieny, told journalists in Geneva that about 100 low- and middle-income countries would receive donated vaccines.

'We are trying to have a first delivery starting in November,' she said.

'The idea is to start with northern hemisphere countries first,' she added - as winter is approaching in this hemisphere.

Dr Kieny said health workers should be among those being prioritised to receive swine flu vaccinations in the recipient countries.

She said data showed that one dose of the vaccine was likely to provide sufficient protection.
More needed

Sanofi-Adventis and GlaxoSmithKline are donating about 150 million doses of the vaccine, with an unspecified amount coming from a third company, Medimmune.

The US is thought to be among nine or 10 rich countries which have also pledged to donate a proportion of their vaccines to developing nations - though the WHO says more doses are needed.

However, the WHO says that vaccines are not the only weapon in the fight against swine flu.

It says other measures, such as school closure, avoidance of large gatherings, antibiotics and personal hygiene are also needed."

View this entire article at: http://news.bbc.co.uk/2/hi/health/8302416.stm

Emory University Online Flu Assessment Tool

Emory University has launched an online flu self-assessment tool, using CDC-developed triage algorithms. The assessment tool is fairly general, as it is used to assess ILI, which is non-specific. The tool helps individuals determine whether the symptoms they have may be caused by a flu virus, whether their illness is severe enough to warrant immediate medical attention, and whether they are at increased risk for developing severe disease. The site also offers practical advice on what to do, and is endorsed by the American College of Emergency Physicians.

The tool can be viewed/navigated at: http://www.h1n1responsecenter.com

The explanation of how Emory developed and pilot tested the tool can be viewed at: http://www.emory.edu/home/news/releases/2009/10/online-h1n1-flu-response-center.html#

CDC H1N1 Vaccine Update

According to a CDC H1N1 briefing update by Director, Dr. Thomas Frieden, 2.4 million doses of the H1N1 vaccine are currently available for ordering in the U.S., with another 2.2 million having already been ordered by states as of October 5th. The first doses of 2009 H1N1 vaccine outside of clinical trials were administered on Monday, October 5, 2009.

Pregnant women still remain a high priority group in the pandemic, and since they cannot receive the nasal spray vaccine which is the only type available in the first batch that has been rolled out, the current demand for vaccine exceeds the supply. However, this is expected to change soon, since a “substantial” amount of vaccine is expected to be available by mid-October, which will consist of flu shots, which pregnant women can receive. The current supply-demand challenge is also expected to change as the number of the population who is susceptible to acquiring the virus decreases since people who contract the disease will develop some immunity.

Also, as of today, 50 million doses of the seasonal vaccine have already been distributed, which is much earlier than usual for the seasonal flu vaccine.

Because the people in groups who cannot receive the nasal spray (pregnant women, children under 1 year, adults older than 50 years, and immunocompromised individuals) are still very much at risk of acquiring the virus, the CDC continues to recommend that they stay home if sick, cover coughs and sneezes, and wash hands often.

The CDC plans to provide information on their website every Friday on vaccine availability.

View the transcript from the briefing at http://cdc.gov/media/transcripts/2009/t091006.htm

International Monetary Fund H1N1 Press Briefing

Last Sunday, October 4^th, the World Bank Human Development Network (HDN) held an hour-long press conference with Ms.Joy Phumaphi (Vice President, World Bank), Dr.Julie Hall (WHO), and Dr.David Nabarro (Senior Flu Coordinator, UN) on the emerging H1N1 pandemic.

The panel highlighted increasing requests from developing countries for support during the pandemic, especially for overall health systems strengthening, communications, surveillance and decision making, and laboratory strengthening. Dr. David Nabarro discussed that even though there has been a demonstrated willingness by drug manufacturers and some countries to donate both vaccines and antivirals to developing countries, the reality of the situation is that there will still a shortage of vaccine for a large proportion of the people who need it in these countries.

Dr. Nabarro described the main priority in the upcoming weeks to be the need to “build up the solidarity between wealthy nations and poor nations to ensure that adequate vaccine is made available so that it can reach health workers and other essential personnel in developing countries in time to help them as the next waves of the pandemic reach them and affect the well-being of their populations.”

He also mentioned a need to see cash donations to enable countries to get prepared, to communicate with their people, to establish better-functioning health systems that can withstand the impact of large numbers of cases of influenza and also to ensure that nations themselves can continue functioning under the onslaught of what will be a high-incidence disease. For this, the UN is now involved in intense discussions with governments so that they can find ways to make the resources available in ways that don't just deal with this pandemic but help to create greater capacity to deal with future public health emergencies like this one.

The panel also highlighted the gap in the availability of antivirals, which has not been talked about enough in the media. Though some antivirals have been donated by pharmaceutical company Roche, and by some governments, the total estimated requirement is around 78 million treatment courses, and so far, we can only really count on having 13 million.

Dr. Nabarro also emphasized the challenges in low resource countries with basic issues like soap and other materials with which people can wash their hands to maintain hygiene, in order to limit transmission of the virus.

Among many others, an issue that was discussed included possible combination of the avian flu H5N1 virus – which is still circulating in some countries – with the 2009 pandemic H1N1 virus.

View the transcript of the briefing at http://www.reliefweb.int/rw/rwb.nsf/db900sid/EGUA7WJNYN/$File/full_report.pdf

WHO H1N1 Situation Update 68, October 2, 2009

The latest WHO situation update on pandemic H1N1 was released today. According to the report, there have been more than 340,000 laboratory confirmed cases worldwide of pandemic influenza H1N1 2009 and over 4100 deaths reported to WHO as of September 27, 2009. These numbers, however, are very likely to be an underestimation of the toll of the pandemic, as many countries have stopped counting individual cases, particularly of milder illness.

Systematic surveillance conducted by the Global Influenza Surveillance Network (GISN), supported by WHO Collaborating Centres and other laboratories, continues to detect sporadic incidents of H1N1 pandemic viruses that show resistance to the antiviral oseltamivir. To date, 28 resistant pandemic H1N1 influenza viruses have been detected and characterized worldwide. All of these viruses show the same H275Y mutation that confers resistance to the antiviral oseltamivir, but not to the antiviral zanamivir. No new resistant pandemic H1N1 influenza viruses have been officially reported to WHO during the past week.

The report also includes:

• Qualitative indicators on the global geographic spread of influenza, trends in acute respiratory diseases, the intensity of respiratory disease activity, and the impact of the pandemic on health-care services.
• Timeline maps, as well as maps illustrating affected countries and number of deaths.
• Updated interim WHO guidance on global surveillance.

For the latest detailed information on trends in the spread and distribution of the virus, view the entire report at http://www.who.int/csr/don/2009_10_02/en/index.html