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Hope for Malaria Vaccine by 2015

British drug maker GlaxoSmithKline is seeking regulatory approval for the world’s first malaria vaccine after trial data showed that it had cut the number of cases in African children.

Experts say that they are optimistic about the possibility of the world’s first vaccine after the trial results.

Malaria, a mosquito-borne parasitic disease, kills hundreds of thousands of people worldwide every year.

Scientists say an effective vaccine is key to attempts to eradicate it.

The vaccine known as RTS,S was found to have almost halved the number of malaria cases in young children in the trial and to have reduced by about 25% the number of malaria cases in infants.

GlaxoSmithKline (GSK) is developing RTS,S with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation.

“Many millions of malaria cases fill the wards of our hospitals,” said Halidou Tinto, a lead investigator on the RTS,S trial from Burkina Faso.

“Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.”

The malaria trial was Africa’s largest-ever clinical trial involving almost 15,500 children in seven countries.

The findings were presented at a medical meeting in Durban, South Africa.

“Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA),” GSK said in a statement.

The company has been developing the vaccine for three decades.

The statement said that the hope now is that the Geneva-based World Health Organization (WHO) may recommend the use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its licence application.

Testing showed that 18 months after vaccination, children aged five to 17 months had a 46% reduction in the risk of clinical malaria compared to unvaccinated contemporaries.

But in infants aged six to 12 weeks at the time of vaccination, there was only a 27% reduction in risk.

A spokeswoman for GSK told the AFP news agency that the company would file its application to the EMA under a process aimed at facilitating new drugs for poorer countries.

UK politician Lynne Featherstone, International Development Minister, said: “Malaria is not just one of the world’s biggest killers of children, it also burdens health systems, hinders children’s development and puts a brake on economic growth. An effective malaria vaccine would have an enormous impact on the developing world.

“We welcome the scientific progress made by this research and look forward to seeing the full results in due course.”

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Malaria Vaccine Shows Early Promise in Clinical Trials

By Rebecca Morelle, BBC Science

A malaria vaccine has shown promising results in early stage clinical trials, according to researchers.

Researchers found the vaccine, which is being developed in the US, protected 12 out of 15 patients from the disease, when given in high doses.

The method is unusual because it involves injecting live but weakened malaria-causing parasites directly into patients to trigger immunity.

The research is published in the journal Science.

Lead author Dr Robert Seder, from the Vaccine Research Center at the National Institutes of Health, in Maryland, said: “We were excited and thrilled by the result, but it is important that we repeat it, extend it and do it in larger numbers.” Continue reading “Malaria Vaccine Shows Early Promise in Clinical Trials”

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Malaria Vaccine: Now A Possibility

GlaxoSmithKline research head Moncef Slaoui explains how change of focus to cellular immunity was key to breakthrough

Moncef Slaoui was on holiday with his family when he heard the results of the first small trial, involving African infants, of the malaria vaccine he helped invent. It was a day he would never forget.

“It was 9 August 2004,” he said. “I’m on vacation with my kids, driving between Chicago and Indianapolis and my phone rings and it’s the team calling from Mozambique. I had to stop for at least an hour. I couldn’t drive any more. That was a big, big moment.”

The vaccine had been classed as around 55-60% effective. It was the first sign that Slaoui, now chair of R&D at GlaxoSmithKline, and his colleagues, were going to be successful in cutting the terrible toll of malaria in Africa. Halving the 200m cases a year would save lives and prevent a huge amount of harm.

It had been a long haul. Slaoui had joined the Belgian lab of what was to become GlaxoSmithKline 23 years ago with a background in immunology. “I brought a fresh perspective in what was then modern immunology,” he said. Some of his new colleagues had started work on a malaria vaccine but “it was more or less stalled conceptually”.

No one then had managed to make a vaccine against a parasite infection. Many in the scientific community thought it impossible. “We heard that a lot. There were many controversial discussions on whether we would be able to achieve success,” said Slaoui.

But his ideas drove the effort in a new and successful direction.

Scientists had been attempting to kill off the parasites injected by malarial mosquitoes as soon as they entered the bloodstream. But any vaccine attempting that has only minutes to work because the parasites quickly go to the liver, where the next stage of their life cycle occurs. After five days there is a burst of new parasites in to the blood cells and that is when the child falls ill.

Slaoui suggested using cellular immunity. “Rather than using antibodies that can kill bacteria or a parasite, we used T-cells that recognise [a] cell is not normal because it is infected by a parasite. It opened the opportunity to find the parasite where it [hid] in the liver and kill it there.”

It was easy to say, but hard to do. They needed to find the right adjuvant, a substance that would stimulate the immune system’s T-cells to mount a response against the malaria parasites.

It was in 1996, eight years after Slaoui joined the vaccine effort, that they became sure they were on the right track – during experiments in conjunction with the Walter Reed army medical centre in Washington DC.

Slaoui said: “It was the first demonstration of the proof of concept that we were able to make a vaccine that killed the parasite in the blood and also in the liver.”

The approach used would later be employed in GSK’s pandemic flu and cervical cancer vaccines, which would make money. Slaoui said GSK would not have dropped the malaria vaccine programme, which was solely for the benefit of people too poor to pay, but that the proftable spin-offs undoubtedly helped.

He said: “GSK Biologicals’ leadership was always totally committed to continue the work on the malaria vaccine for two equally good reasons. The malaria vaccine was a great vehicle to advance our platform of adjuvants for many other vaccines, [ones] that were more able to give us a return. But secondly there was truly a commitment to public health in general and our responsibility to society to make vaccines for those who would most benefit, even when they could not afford it.”

This was a stronger motivation in the vaccine community than in the pharmaceutical industry. He added: “Vaccines are associated with public health and the developing world and babies that you save from major infections, and therefore the idealistic motivation is very strong.”

It remained the case, he said. “Yesterday in Seattle [when the results were published] I was with some of the first core-team members – we all started together. It was very emotional.

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Malaria Deaths Fall over 20% Worldwide in Last Decade

There has been a fall of just over 20% in the number of deaths from malaria worldwide in the past decade, the World Health Organization says.

A new report said that one-third of the 108 countries where malaria was endemic were on course to eradicate the disease within 10 years.

Experts said if targets continued to be met, a further three million lives could be saved by 2015.

Malaria is one of the deadliest global diseases, particularly in Africa.

In 2009, 781,000 people died from malaria. The mosquito-borne disease is most prevalent in sub-Saharan Africa, where 85% of deaths occurred, most of them children under five.

An earlier report here incorrectly referred to a 40% drop in deaths.

It has been eradicated from three countries since 2007 – Morocco, Turkmenistan and Armenia.

The Roll Back Malaria Partnership aims to eliminate malaria in another eight to 10 countries by the end of 2015, including the entire WHO European Region.

Robert Newman, director of the WHO’s Global Malaria Programme, said “remarkable progress” had been made.

“Better diagnostic testing and surveillance has provided a clearer picture of where we are on the ground – and has shown that there are countries eliminating malaria in all endemic regions of the world,” he told an international Malaria Forum conference in Seattle.

“We know that we can save lives with today’s tools.”

Global eradication

A global malaria eradication campaign, launched by WHO in 1955, succeeded in eliminating the disease in 16 countries and territories.

But after less than two decades, the WHO decided to concentrate instead on the less ambitious goal of malaria control.

However, another eight nations were declared malaria-free up until 1987, when certification was abandoned for 20 years.

In recent years, interest in malaria eradication as a long-term goal has re-emerged.

The WHO estimates that malaria causes significant economic losses, and can decrease gross domestic product (GDP) by as much as 1.3% in countries with high levels of transmission.

In the worst-affected countries, the disease accounts for: Up to 40% of public health expenditures; 30% to 50% of inpatient hospital admissions; and up to 60% of outpatient health clinic visits.

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GlaxoSmithKline Malaria Vaccine Tests Show Hopeful Results

ATLANTA — The quest for the world’s first malaria vaccine appears to have taken a big step: A study in Africa shows experimental shots cut the risk of disease in young children by half.

The initial results from a final stage of vaccine testing were released Tuesday, and the vaccine’s developers called it a milestone in helping to tame one of the world’s most devastating killers.

However, the vaccine won’t be available for at least three years, as crucial further testing must be completed to see how well it works in infants and how long protection lasts. Then the vaccine must be reviewed by government agencies in Europe and in individual African countries.

“We still have a way to go,” Tsiri Agbenyega, lead researcher for the African study, said in a conference call with reporters.

The early results show the vaccine is only about 50 percent effective, significantly lower than the protection seen in more common vaccines. But some experts said it’s a vast improvement over the current situation, and could still save hundreds of thousands of lives.

Globally, malaria kills nearly a million people annually. More than 90 percent of them live in Africa, and most are young children and pregnant women.

Scientists have been trying for decades to develop a malaria vaccine and the one tested – developed by GlaxoSmithKline – is furthest along. Without a vaccine, efforts have concentrated on malaria drugs and other ways to prevent infection such as mosquito bed netting and insecticides.

The new vaccine targets a malaria parasite found in sub-Saharan Africa. Malaria spreads through mosquitoes, which bite people and flush malaria parasites into the bloodstream. The parasites cause bouts of high fever and can end in fatal organ failure.

In the United States, malaria has been eradicated since the early 1950s. Only about 1,500 cases are diagnosed in the U.S. each year, most of them travelers or immigrants from South Asia, sub-Saharan Africa or other places where malaria commonly spreads.

The new study – still under way – began in 2009 and involves more than 15,000 children in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.

The results focus on about 6,000 children ages 5 to 17 months. A year after three doses, the vaccinated children had about half as many cases of malaria as a group that didn’t get the vaccine.

Meanwhile, experts are waiting for results from research in a younger group – infants ages 6 to 12 weeks. That’s the age when children in sub-Saharan Africa are vaccinated against other diseases. Earlier vaccination also affords earlier protection.

Although there are an array of vaccines against viruses and bacteria, there has never been an effective vaccine against a parasite, which is a more complicated organism. Adding to the complexity is there are five species of malaria parasites – the new vaccine is designed specifically to protect against the deadliest one, which is common in sub-Saharan Africa.

GlaxoSmithKline paid for the study along with the PATH Malaria Vaccine Initiative, a program funded by the Bill & Melinda Gates Foundation. The results were released Tuesday at a malaria conference in Seattle and published by the New England Journal of Medicine.

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Malaria Vaccine Trial Raises Hope

By Matt McGrat,  Science reporter

Researchers are to expand a clinical trial of a new malaria vaccine after promising results in a preliminary study in Burkina Faso.

The trial was designed to test safety, but researchers found that vaccinated children had high levels of protection.

Described as a “most encouraging” result, a larger study involving 800 children is now to take place in Mali.

The scientists involved say they are hopeful that the vaccine will ultimately be very cheap to produce.

Around a hundred different malaria vaccine candidates have been developed to date but the MSP3 vaccine tested in Burkina Faso is only the second one to show a substantial level of protection against the illness.

The randomised, double blind study involved 45 children. It set out to test the safety of the vaccine but this follow up study found that children who received it had an incidence of the disease three to four times lower than children who did not.

Initially the children were split into three groups, with two of them receiving the experimental malaria vaccine developed by Dr Pierre Druilhe at the Pasteur Institute in Paris.

“Those two groups had very similar types of immune response, elicited by the vaccine, and the protection is almost identical, so it reinforces the confidence despite the fact that we are still dealing with a small group,” he said.

The vaccine is based on the fact that some adults in Africa acquire immunity because they are constantly exposed to the disease.

Early days

Dr Druilhe and his team discovered a key protein, MSP3, which provokes the body into producing antibodies that kill the parasite.

He said the protein is unique as it does not change much between different strains of the plasmodium parasite that causes malaria. This is believed to be a critical factor in developing an efficient vaccine.

He added: “We performed a large number of epidemiological studies that confirm that there was an association between that vaccine candidate and acquired protection, so when you immunise with this molecule you indeed induce protection.”

Another scientist involved with the Burkina Faso study was Dr Louis Miller, the former head of the Malaria Vaccine Branch of the US National Institutes of Health.

He said: “I was always in favour of this approach as it offered a chance in a field with few successes. I found the results of this preliminary study in Burkina Faso to be most encouraging.”

High transmission

Encouraged by the early results, Dr Druilhe said the trial has now been expanded to 800 children in Mali. But he remains cautious.

“There have been too many claims of effective vaccines so we have to remain very cautious. It has to be confirmed and we have started on work to do that confirmation. Essentially the trial in Mali is about 20 times larger, in extremely high transmission conditions, so it should yield very clear cut results – this will be black and white.”

The other vaccine candidate that has shown success against malaria is called RTS, S. It has been funded by the Bill and Melinda Gates Foundation and is set to go into production with pharmaceutical giant, GlaxoSmithKline.

But there are concerns that it could be expensive, especially for people in Africa and other regions affected by the disease.

Dr Druilhe says his vaccine could be a lot cheaper – perhaps half a dollar or less a bottle.

If you like this article, I’d recommend my book “If I Was Famous, I’d Have a Lot to Say”

The results of the Burkina Faso trial were published in The New England Journal of Medicine.

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Drug Firms Cut Vaccine Prices to the Developing World

Several major drugs companies have announced big cuts to the amounts they charge for their vaccines in the developing world.

GlaxoSmithKline (GSK), Merck, Johnson & Johnson and Sanofi-Aventis have agreed to cut prices through the international vaccine alliance Gavi.

GSK said it would cut the price of its vaccine for rotavirus by 67% to $2.50 (£1.50) a dose in poor countries.

Rotavirus-related diarrhoea kills more than 500,000 children a year.

The vaccine will be subsidised by higher prices being charged in richer countries.

The rotavirus vaccine, for example, would cost about $50 in the US.

‘Helped out’

“What we need is a return to invest in the next generation of new vaccines and drugs and that has to come from the profits of the medicines or the vaccines,” Andrew Witty, chief executive of GSK told the BBC.

“But it’s obvious that if you’re in Kenya or a slum in Malawi or somewhere like that there is no capacity for those people to contribute to it, so they have to be helped out by the contribution from the middle and the richer (countries).”

Gavi is a partnership representing public and private sector organisations that helps to fund mass vaccination programmes in developing countries.

It is committed to funding the introduction of rotavirus vaccinations in 40% of the poorest countries by 2015, but it faced a $3.7bn funding shortfall and so has been appealing for price cuts and donations.

It will be holding a pledging conference in London on 13 June.

Anti-poverty campaigners welcomed the move but also called on world leaders to act.

“The pricing commitments announced today help drive momentum, but Gavi’s ambition to save four million lives in the next five years is only achievable if the international donor community steps up to the plate on 13 June,” said Jamie Drummond, executive director of campaign group ONE.

Malaria vaccine

Merck has said it will provide its own rotavirus vaccine for $5 a dose, coming down to $3.50 once more than 30 million doses have been sold.

The price Gavi pays for pentavalent vaccines, which protect against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type B will be cut by two Indian firms, Serum Institute and Panacea Biotec.

GSK also said it was very close to developing the world’s first malaria vaccine, which is unusual because there is no market for it in the West.

That means there is no opportunity for patients in richer countries to subsidise those in poorer countries.

As a result, GSK said that if the vaccine comes to market it would be sold at a price that provides a small return of 5%, which would be used to fund the next generation of malaria treatments.

Save the Children called on other companies to replicate the “landmark move” which it said could prevent hundreds of thousands of “needless deaths”.

“It’s important that Gavi now uses this to spur other vaccine producers to reduce prices and work to foster greater competition amongst producers to drive prices down even further and help even more children,” said chief executive Justin Forsyth.

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Generic Malaria Drug Approval Granted to Glenmark Pharmaceuticals

The United States Food and Drug Administration (FDA) has granted Glenmark Pharmaceuticals final approval to sell a generic version of GlaxoSmithKline (GSK) malaria drug Malarone.

In April 2010, Glenmark settled a patent litigation with GlaxoSmithKline over atovaquone and proguanil hydrochloride 250 milligram/100mg tablets–the generic version of Malarone.

The Indian company can sell the generic tablets under a royalty-bearing license from GlaxoSmithKline in the third quarter of 2011, or earlier under certain circumstances.

KAM

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