MALARIA: vaccine could have extra benefits

LILONGWE, 20 June 2011 (IRIN)

 Photo: SAHIMS
Children who received the vaccine are monitored for malaria

The malaria vaccine that has eluded medical science for decades is now within reach, with the final phase of clinical trials underway in seven African countries, including Malawi, where the disease claims 6,500 lives a year, most of them children under the age of five.
Tisungane Mvalo, head of the research team at the Malawian trial site, which is being run in partnership with the University of North Carolina's Institute for Global Health and Infectious Diseases, said the current methods for controlling the incidence of malaria in Malawi have had limited success.
"We have had a moderate reduction in infant mortality from interventions like bed nets and insecticides but malaria remains the leading cause of infant mortality," he said. "There still needs to be an additional intervention."
The multi-country trial of the malaria vaccine RTS,S, made by GlaxoSmithKline Biologicals, is one of the largest ever carried out in sub-Saharan Africa. With funding from GlaxoSmithKline and the PATH Malaria Vaccine Initiative - an NGO that develops research for malaria - 15,000 newborns and infants are being inoculated at 11 sites across the region.
The children are then monitored over a period of 36 months to assess the effectiveness of RTS,S, which in previous studies reduced cases of severe malaria in infants by 53 percent. If the results, due to be released later this, year confirm the vaccine's efficacy in preventing malaria, it could be made available as early as 2015.
"It's a very exciting time," said PATH Director Dr Christian Loucq, speaking from his office in Washington. "We have estimated in our models that a vaccine like this could save hundreds of thousands of lives a year."

The high cost of malaria
A malaria vaccine would not only save lives, it would also alleviate the great burden of the disease on health systems in economically stretched developing countries.
Dr Karl Seydel, a paediatrician at Queen Elizabeth Central Hospital in Blantyre, Malawi, said the impact of the disease on the public health system was "overwhelming" - 5.5 million cases of malaria, equivalent to a third of the country's population, were reported in 2010.
"It drains the resources," he told IRIN. "We could use that money for other things; we could build more hospitals or hire more nurses."
We have estimated...that a vaccine like this could save hundreds of thousands of lives a year
He estimated that during the rainy season, when bites from mosquitoes infected with the malaria parasite are most common, about half of all admissions to the hospital's paediatric ward were due to malaria. The ward was designed for 150 patients but often has to accommodate twice that number.
Malawi has a good track record for immunizing children: 98 percent have received the standard vaccines recommended by the World Health Organization (WHO). The addition of a malaria vaccine, even at 50 percent effectiveness, could greatly reduce the number of children needing expensive hospital care.
Malaria prevention has been less successful than was hoped. According to the 2010 Malawi Demographic and Health Survey, about 70 percent of households have bed nets, but just half the children under five are using them.
Mvalo said the adults in a household often used the nets, even though children are most susceptible to developing severe malaria. In some parts of the country mosquitoes have also started showing resistance to insecticides.
"Each control method has its shortfalls," Mvalo said. "That is why a vaccine is a good alternative - not a replacement, but a good alternative."
Most researchers agree that a malaria vaccine will not substitute for current preventative measures, but could greatly reduce mortality from the disease and create huge financial gains for countries where malaria is endemic. Public health researchers estimate that in such countries, malaria directly absorbs one percent of GDP, excluding indirect costs like loss of work hours.
"Solving the problem of malaria would very much help in terms of economic development," said Loucq.
http://www.irinnews.org/report.aspx?reportID=93024

POVERTY: MADAGASCAR: Vaccination efforts pay off

ANKAREIRA, 9 June 2011 (IRIN)

 Photo: Hannah McNeish/IRIN
Waiting for vaccinations at the clinic in Akareira

 Tahiri and her baby daughter have joined a courtyard full of women sheltering their babies from the midday sun at a health centre in Ankareira, near Madagascar's southern tip.
"I had a two-year-old and a three-year-old child and they both got sick and then died, one after the other," she said.
Tahiri, who grows rice and manioc in one of the poorest, most drought-affected regions of the country, does not know what illnesses killed her first two children, but she has brought her daughter to the clinic to be vaccinated because she wants to give her the best chance "to have good health".
Madagascar has reduced its under-five child mortality rate by more than 60 percent over the last decade. Part of that success has been down to increased vaccine coverage, with the World Health Organization and UN Children’s Fund (UNICEF) estimating that 78 percent of the country's children were immunized in 2009, compared to 57 percent in 2000.
That increase was made possible partly as a result of funding from the Global Alliance of Vaccines and Immunization (GAVI), a public-private partnership launched in 2000 to improve access to vaccines in developing countries such as Madagascar, where it has contributed US$56.5 million.
GAVI says its support to NGO and public health programmes which deliver vaccines has saved five million children from premature death over the last decade, and that it can save four million more over the next four years by doubling the number it helps immunize to half a billion and introducing two new vaccines.
To do this GAVI estimates it will need $6.8 billion, but so far donors have only promised to fund about half that amount. GAVI hopes to raise the remaining $3.7 billion at a pledging conference in London on 13 June.

Cost-effective
"For a long time vaccines were unavailable in the developing world, in countries such as Madagascar, either because the appropriate vaccines for these kinds of countries and conditions didn't exist, or because they were too expensive," said GAVI spokesman Ed Harris on a recent visit to Madagascar.
Harris said that while countries like Madagascar clearly needed development in many sectors, vaccines were one of the most cost-effective interventions.
His comments are supported by findings from two studies conducted at the Johns Hopkins Bloomberg School of Public Health in Baltimore published in the June issue of Health Affairs. Both studies project that boosting efforts to develop and deliver vaccines could not only save the lives of 6.4 million children but save $6.2 billion in treatment costs, and achieve $145 billion in long-term economic gains by avoiding the lost productivity resulting from premature death.
UNICEF Madagascar representative Bruno Maes said now more than ever, support from organizations like GAVI was vital as Madagascar continues to feel the effects of a protracted political and economic crisis which started in 2008 and has caused poverty levels to increase and government spending on health to drop from $8 to $2 per person.
"This is a drastic reduction for essential services for children, and we are very concerned about their vulnerability," said Maes.
According to UNICEF, which was one of GAVI's founding partners, 38,000 Malagasy children under the age of five still die every year and under-funding of the health sector has started to reverse some of the country's immunization gains. Coverage for measles vaccination, for example, has fallen from 2007 levels of 81 percent to 64 percent in 2010.
Marie-Josephine Hantomalala, head of the clinic in Ankareira which does vaccinations twice a week, is worried she will have to turn away the crowd of women and their children waiting outside, many of whom left their homes at dawn to reach the clinic by foot.
"The fridge for the vaccines has broken down and the temperature has dropped to 19 degrees," she said, adding that a vaccines expert in the nearest city, over two hours drive away, could not respond to her call for assistance because he lacked petrol.
In addition to providing affordable vaccines to Madagascar, GAVI has spent almost $10 million on strengthening the health system to deliver them in remote rural clinics that often lack the kerosene to run fridges needed for vaccine storage.
District Doctor Andriatsararanto Rabetsivahiny, who works in the Amboasary-Sud region of southeastern Madagascar, said in an area where over 130,000 people live more than 5km from the nearest health centre, initiatives to increase vaccine coverage had greatly helped reduce child mortality.
While malaria and diarrhoea were still major causes of deaths in children, deaths from measles were much less common than previously. He added that the biggest killer was malnutrition as undernourished children were vulnerable to attack from a number of diseases and often too weak to survive them.
He said in an area with little cultivatable land and high unemployment, "in times of difficulty people live off tamarind mixed with ash and water - morning, noon and night, just to survive".

Two new vaccines in pipeline
Manjarasoa, 18, has walked for an hour with her one-year-old baby to reach the Ankareira clinic.
"It's been five days since he's had diarrhoea. I've been feeding him herbal tea but it just hasn't stopped," she said.
Since 2001, GAVI has helped immunize children against tetanus, diphtheria, hepatitus B and pertussis (whooping cough) using the tetravalent vaccine. The introduction of the pentavalent vaccine in 2008 added protection against Haemophilus influenzae type B (Hib).
Now GAVI, along with UNICEF and other partners, wants to help developing countries introduce two new vaccines. The first would protect children from pneumococcal disease, the leading cause of pneumonia, and the second would provide protection from rotavirus, the most common cause of severe diarrhoea. Pneumonia and diarrhoea are the two leading killers of children under the age of five, causing nearly 40 percent of all childhood deaths.
"Children in rich countries don't die from diarrhoea," pointed out Shanta Bloemen from UNICEF South Africa, while children in the poorest most remote areas who could not easily be reached with treatment were vulnerable.
"If every child is vaccinated you're giving them the primary foundation to survive the first few years of life when they are most vulnerable to disease and have weak immune systems, and in Madagascar... almost half the children are malnourished so they are vulnerable," she told IRIN.
Madagascar has been earmarked among the developing countries which could benefit from GAVI funding for pneumococcal and rotavirus vaccines, but the availability of financing will depend largely on the success of the pledging conference and on the price of the vaccines coming down. In response to a recent tender by UNICEF, which procures the majority of vaccines funded by GAVI, Merck & Co and GlaxoSmithKline have significantly reduced the price of their rotavirus vaccines.
With a child dying every 20 seconds from a vaccine-preventable disease, Harris said: "At stake on 13 June are potentially millions of lives."
http://www.irinnews.org/report.aspx?reportID=92939

MALARIA: Could malaria vaccine “sit on the shelf”?

13 Dec 2010 : Paul Chinnock
By the year 2015, the first vaccine against malaria could be ready for use on a wide scale. But concerns have been expressed that inadequate planning could prevent it reaching those who are most in need of protection against the disease.
Of several potential malaria vaccines under investigation, the RTS,S vaccine is at the most advanced stage. Its history dates back to research conducted by GlaxoSmithKline and the Walter Reed Army Institute of Research in the mid-1980s. The first human trials began a decade later. A partnership between GSK and the non-profit PATH Malaria Vaccine Initiative (MVI) has made possible its further development.
Phase 3 clinical trials in sub-Saharan Africa began in 2009. Eleven sites in seven countries will enrol a total of 16,000 infants and children. Steps have been taken to expedite the rapid approval of the vaccine by African regulatory authorities, as well as by officials at WHO and the European Medicines Agency, assuming that the trials confirm the effectiveness and safety of RTS,S. It is hoped that this will lead on to the vaccine entering general use as early as 2015.
The level of effectiveness of the vaccine will not be clear until the Phase 3 trials have been completed. It is already apparent that it will not be as effective as vaccines for many other diseases, but a Phase 2 trial in Tanzania [1] found that RTS,S reduced the risk of Plasmodium falciparum infection by 65% and this degree of effectiveness (or even lower) could still save many lives each year. Malaria control programmes would use the vaccine in combination with other tools – residual insecticide spraying of houses, long-acting insecticide-treated bednets, rapid diagnostic tests, and treatment using artemisinin combination therapy.
But the fear of many malaria specialists is that, once the vaccine is ready, health systems in malaria-endemic countries may not be able to bring it into use, because of inadequate preparation. “After decades of research and tens of millions of dollars invested … it would be scandalous if this vaccine just sits on the shelf,” said Yvette Collymore of MVI speaking at a recent conference in Washington DC, USA.
The concern expressed by MVI raises a wider issue. In recent years – with new funding, from sources such as the Gates Foundation and the establishment of a number of public–private product development partnerships – we have seen more R&D efforts targeted on the infectious diseases of poverty. An encouraging number of new tools are now in the development pipeline. But R&D is only the beginning. It will be essential that systems are in place to put the new tools to work and make them available to all those who need them.

Reference
Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F et al. (2008). Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med; 359(24):2533-2544. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19064623

http://www.tropika.net/svc/news/20101213/Chinnock-20101213-News-RTSS

MALARIA: Trials Advance for a Malaria Vaccine,

Rebecca Voelker
As Trials Advance for a Malaria Vaccine, Policy Makers Urged to Plan for Its Use

As the first promising malaria vaccine makes its way through phase 3 clinical trials in sub-Saharan Africa, stakeholders' greatest fears go beyond the possibility that the vaccine may fail to meet safety and efficacy goals. They worry that even if the vaccine is licensed, inadequate planning for its distribution could leave it to languish in warehouses.
“After decades of research and tens of millions of dollars invested . . . it would be scandalous if this vaccine just sits on the shelf,” said Yvette Collymore, MA, of the nonprofit PATH Malaria Vaccine Initiative (MVI), during a recent Washington, DC, conference.
Clinical trials like this one in Tanzania showed that the RTS,S malaria vaccine has a favorable safety and efficacy profile. The vaccine is now in phase 3 trials.
 (John-Michael Maas/Darby Communications/AP Images)

MVI and the vaccine's creator, GlaxoSmithKline (GSK) Biologicals, partnered in 2001 to develop the vaccine for infants and young children in sub-Saharan Africa.
http://jama.ama-assn.org/content/304/21/2348.extract

MALARIA: Malaria vaccine closer than ever, scientists say

Karin Zeitvogel (AFP)


WASHINGTON — Scientists are closer than ever to rolling out the first malaria vaccine, which could be available in Africa by 2015, a co-inventor of the shot against the killer disease said Tuesday.

Advanced trials of the RTS,S vaccine against falciparum malaria, the deadliest strain of the disease, are under way in seven African countries and going "very well," said GlaxoSmithKline researcher Joe Cohen, who has been working on developing the vaccine for over 20 years.

"We believe we'll have the first data coming out of the trials in 2012, and, to make a long story short, we could have the first implementation in Africa between 2015 and 2016," he told AFP.

Cohen was speaking at a conference in Washington examining ways to beat malaria.

Some 12,000 children have already been enrolled in the Phase III trials in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania, which have an enrollment target of 16,000 children.

The trial protocol varies from country to country -- even from village to village -- to take into account cultural sensitivities, but the basics are the same, said Ghana clinical epidemiologist Kwaku Poku Asante and Ally Olutu, a clinician from Kenya. The pair are working on the vaccine trials.
Children have to be in good health to join the trial, and will be followed up for 32 months, Asante said.
The results of smaller-scale phase II trials, which were announced in 2008, showed RTS,S was 53 percent effective against clinical falciparum malaria in young children and up to 65 percent effective in infants, the two groups most at-risk from the parasitic disease.

If RTS,S passes muster in the phase III trials and is licensed, it "will save many, many hundreds of thousands of lives in Africa," even if it is only partially effective against malaria, said Cohen.

But completing the vast trial in Africa and rolling out the vaccine will not signal an end to the process to develop malaria vaccines, he and other researchers warned.

RTS,S is only a stepping stone to wiping out the disease that threatens more than a third of the world's population and kills some 900,000 people a year, most of them in Africa.
According to organizers of the Washington conference, some 200 people die of malaria every hour of every day every year, most of them children in Africa.
Malaria is one of the main obstacles to socio-economic development in Africa, and developing effective vaccines against the disease would have an enormous effect on reducing its negative impact, they said.

"We must look ahead to an even better second generation vaccine, one that is maybe 80 percent effective," said Cohen.

"That vaccine could address the malaria parasites that are prevalent elsewhere in the world, such as Asia and Latin America, where the plasmodium vivax parasite predominates."

But he worried the global economic slump could put the brakes on malaria vaccine research.

"The financial crisis has had a big impact on the package of money that's available," said Cohen.
"Vaccines against other diseases that are ready to be implemented in Africa are being delayed because financing is not available," he added, warning the same could happen to RTS,S if there is no money available for a wide-scale roll-out after it is approved.
PATH Malaria Vaccine Initiative (MVI) director Christian Loucq urged investors from the public and private sectors who teamed up to help make the RTS,S more than just a glint in Cohen's eye to keep investing in malaria research even after the first vaccine becomes reality.

Funding is needed, for instance, to develop a way to "protect the mosquito," said Loucq.

Mosquitoes get the malaria parasite when they bite an infected person, and then pass it back into the human chain when they bite someone else, Loucq explained.

"If you can effectively and widely prevent transmission from human to mosquitoes, you will prevent transmission of the disease. We believe that is our biggest hope for achieving our ultimate goal -- eliminating malaria -- but that's not going to happen before 2025," he said.

"In the meantime, if we forget to keep investing in research we might, like we did in the '60s, once again lose the battle against malaria."
http://www.google.com/hostednews/afp/article/ALeqM5hDd-wIF22ngXvkXIF1bUXxXiEXmQ?docId=CNG.6d8134b4ddb27ece50584ad27507f332.b61

TUBERCULOSIS: Patented Drug Expansion

JOHANNESBURG, 12 May 2010 (PLUSNEWS) - A South African government agency has become the first to join the world's leading patent pool for neglected diseases, a move that could bolster home-grown innovations in the fight against diseases including tuberculosis (TB). The Technology Innovation Agency (TIA), a government body, recently announced that it had joined a patent pool established by pharmaceutical company GlaxoSmithKline (GSK) to spur research into 16 neglected tropical diseases. The TIA's move means local researchers will have access to more than 2,300 existing patents as well as related knowledge on the diseases, including TB and malaria. The patent pool - which aligns to US Food and Drug Administration definitions of neglected diseases and does not include antiretrovirals (ARVs), used to treat HIV - is a voluntary arrangement in which companies in the same sector, like pharmaceuticals, agree to share patented intellectual property and usually pay a royalty for access to drug formulations and research. "If other companies in South Africa can come up with innovative ways in which they can use the information in the patent pool, then TIA will help them put plans together and implement [them]," said Dr Carl Montague, TIA's health portfolio manager. iThemba Pharmaceuticals, a private South African drug company partly funded by TIA, signed on to the pool earlier this year to accelerate its own TB and malaria research, said company spokesperson Dr Chris Eldin. Montague noted that there was a wealth of opportunity available to drug researchers, but "We have to ensure that the pool can be meaningfully exploited, and that we get access to the researchers who have the knowledge [of] the patents [that have been] generated," he told IRIN/PlusNews. "Having access to hundreds of patents is a daunting prospect and we need help in evaluating patents and selecting the best targets for further work, so that we don't waste our meagre resources." The World Health Organization (WHO) lists TB as the leading killer of people living with HIV, and has estimated that South Africa has an HIV prevalence rate of about 18 percent and one of the world's highest TB burdens.