World’s first Malaria Vaccine on target for 2015

Health experts are adamant that the the world’s first malaria vaccine will be available on the market by 2015 as another option for malaria prevention, after a hugely encouraging study showed that thousands of deaths could be prevented from the deadly disease.

Publishing their findings in PLOS Medicine, researchers involved in clinical trials of the drug RTS,S, reported that for every 1,000 children who receive the vaccine, around 800 cases of malaria could be prevented.

In follow-up trials 18 months after the initial injections, researchers found RTS,S was remarkably able to offer protection even at that stage.

The vaccine’s manufacturer is pharmaceutical giant GlaxoSmithKline (GSK), the company who produce popular cold sore treatment Zovirax (aciclovir) and weight loss treatment Alli, and they have now requested regulatory approval, meaning this is the first vaccine of its kind to arrive at this milestone.

Several African countries were involved in the trials, mainly as around 90% of deaths from malaria occur in sub-Saharan Africa (SSA), and shockingly 77% of the deaths are children under the age of 5.
An estimated 1,500 infants and children were administered the new RTS,S vaccine and researchers analysed them all again after 18 months, discovering that cases of malaria declined by half in youngsters. For infants (at six to 12 weeks of age when first vaccinated) RTS,S managed to reduce malaria cases by a quarter.

GSK commented: “Over 18 months of follow-up, RTS,S was shown to almost halve the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination).”

Quite commendably, GSK have pledged to offer their RTS,S vaccine at cost price plus 5%, stating such a move would help to provide the funding for continued research into prevention and treatments for various tropical diseases.

Despite the effectiveness of the malaria vaccine appearing to decline somewhat over time, the report claims it could be highly beneficial to areas where there are high rates of malaria.

For instance, trials demonstrated that in certain Kenyan cities where people are at risk of repeated infection of the deadly disease, around 2,000 cases of clinical malaria were averted for every 1,000 children that were given the vaccine.

GSK say that the vaccine combined with other preventative measures like bed nets and insect repellents (i.e. Jungle Formula), may offer a massive step forward in the battle against malaria. According to the latest estimates into the disease, released in December 2013, there were a staggering 207 million cases of malaria during 2012 and in Africa a child dies every minute because of it.
Scientists are also conducting investigations to determine if a booster may offer even more chances of success.

Professor Sanjeev Krishna of St George’s University of London, did not participate in trials of the vaccine, but did offer a review of the paper for the journal. He said: “This is a milestone. The landscape of malaria vaccine development is littered with carcasses, with vaccines dying left, right and centre. To get to this stage is very encouraging indeed. We eagerly await the next results to see how long-lasting protection is and whether a booster adds further potential. We need to keep a watchful eye for adverse events but everything appears on track for the vaccine to be approved as early as next year.”

GSK’s malaria vaccine could be in use by 2015

The world’s very first malaria vaccine could finally be available in 2015 and in widespread use after “significant” results were shown during an ongoing clinical trial. This would offer a significant boost alongside current options for malaria treatment and prevention.

British pharmaceutical giant GlaxoSmithKline (GSK) are behind the development of the new vaccine and say they will be submitting an application for a licence from the European Medicines Agency in the new year.

The vaccine, currently being referred to as RTS, S, has been developed by both GSK together with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation. Trial data has so far been promising in the quest to fight a deadly disease which kills an estimated 660,000 people every year.

RTS, S is one of 20 such vaccines in development, but looks on course to be the first to receive European Medicines Agency approval following hugely encouraging results from Africa’s largest ever clinical trial, involving almost 15,500 babies and children across seven African countries.

Testing showed that after 18 of receiving their vaccination, infants aged between five to 17 months were an incredible 46% less at risk of malaria in comparison to those unvaccinated.  However, infants aged six to 12 weeks when vaccinated were only 27% less at risk.

If the vaccine is fully proved to be safe and effective for use, the World Health Organisation has suggested they are willing to support its widespread use from 2015 onwards. GSK have said they will help to provide fund research into tropical diseases by selling the vaccine at cost price plus 5%, and scientists will next investigate whether a ‘booster dose’ can lengthen protection against malaria in the long-term.

Halidou Tinto, one of the study’s principal investigators, is greatly excited by the vaccines possibilities, saying it had “the potential to have a significant public health impact.”

Tinto commented: “Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease.”

GSK chief executive Sir Andrew Witty said: “While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive. These data support our decision to submit a regulatory application for the vaccine candidate which, if successful, would bring us a step closer to having an additional tool to fight this deadly disease.”

David Lalloo, professor of tropical medicine at Liverpool School of Tropical Medicine, said: “We’ve known about this vaccine for a number of years now and all the studies have shown that it affects around 50 per cent and in younger age groups who don’t have such a good immune response that is down to around 30 per cent. The other concern is that there have been several studies that show it wanes over time…there are still uncertainties about duration and effects. Having said that, given the huge number of malaria deaths and malaria cases, even a relatively small reduction has the potential to make a big difference.”

Dismay at the effectiveness of GSK’s malaria vaccine

The expectations and anticipation regarding the world’s first potential malaria vaccine have been dealt a blow after trial results demonstrated that the protection the vaccine offers, can significantly diminish and disappear altogether over time, disappointing researchers who had high hopes for it.

Developed by British pharmaceutical giant GlaxoSmithKline (GSK), the new vaccine is currently only referred to as ‘RTS,S’. Scientists state that full data from final-stage trials which include 15,000 children, are expected by the end of 2014. However, early results from the vaccine are not encouraging and expose the difficulties in creating a vaccine that offers full protection from a deadly disease such as malaria that claims the lives of more than 650,000 children every year – the most ‘at risk’ group in regards to mosquito bites.

The vaccine has been primarily engineered to help babies aged between six to 12 weeks and in a large-scale phase III trial that was carried out last year, only a third of babies aged within this range were prevented from becoming ill after being administered the new vaccine. Moreover, the protection was lower than what was evident in older children.

Microsoft co-founder Bill Gates, worth an estimated £40bn, was one of the backers behind the research, and after those results emerged last year he commented: “The efficacy came back lower than we had hoped, but developing a vaccine against a parasite is a very hard thing to do.”

Christopher Plowe, a malaria researcher at the University of Maryland School of Medicine in the United States, who was not involved in the RTS,S trial, also spoke on the findings last year, saying: “The results are kind of disappointing because we’d all like to see a malaria vaccine that has closer to 80 percent or 100 percent efficacy.”

Results of the latest data were published this week in the New England Journal of Medicine. Although the RTS,S vaccine was found to have a rate of protecting peaking at 53%, after an average of merely eight months, the level of protection had declined at an alarming rate.

Ally Olotu of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme in Kenya, who led the follow-up study, said: “It was a bit surprising to see the efficacy waned so significantly over time. In the fourth year, the vaccine did not show any protection.”

A GSK spokesperson commented on the latest results, stating that because they were derived from a small, mid-stage trial, they did not “provide definitive answers about the duration of protection or how the vaccine candidate works in different malaria transmission settings.”

Phillip Bejon, a researcher at the KEMRI-Wellcome Trust programme, was involved with the study and he said in spite of the decreasing effectiveness, “there is still a clear benefit to the vaccine.”

Bejon added: “Many of the children (in Africa) will experience multiple episodes of clinical malaria infection, but overall we found that 65 cases of malaria were averted over the four-year period for every 100 children vaccinated. We now need to look at whether offering a vaccine booster can sustain efficacy for longer.”

Sugar content and calories in soft drinks to be downsized

In the beginning months of 2012, the government created a new ‘Public Health Responsibility Deal’ pledge, aiming to reduce 5 billion calories from the nation’s daily diet. The primary reason for this is due to the fact that England’s obesity rates are amongst the worst across Europe and in the developed world. It is believed that over 60% of adults and a third of 10 and 11 year olds are overweight or obese, and clearly things need to change.

Therefore, working together with some of the country’s biggest supermarkets, food manufacturers, caterers and food outlets, The Department of Health has decided to target alcohol, food, health at work and physical activity.

This brings us to the news emerging this week that leading drinks manufacturers are starting to acknowledge the fact that high sugar content in their drinks is having a negative impact on obesity levels and that action is also needed to try and protect teeth from a premature decay.

Soft drinks such as Lucozade, Ribena and Irn-Bru are now set to see their sugar content reduced by up to 10% – actions that maybe should have been considered long before now.

Presently, a can of Irn-Bru contains about 6 teaspoons of sugar and if this is not horrifying enough, a 500ml bottle of Ribena contains about a staggering 52.6g of sugar (13 teaspoons) and 216 calories.
Both drinks are produced by pharmaceutical giant GlaxoSmithKline who released a statement via a spokeswoman, saying: “We have a responsibility to help people make healthier choices. We are saying this is a first step. It is the start of a journey.”

The manufacturers of Irn-Bru, AG Barr, have also relented from government pressure and will cut the calorie content in their range of drinks by 5%. In addition, the Ribena ready-to-drink and Lucozade Energy drinks will see a drop  of sugar and calorie content by up to 10%, and J2O will launch two flavours in a new slim line can that contain 10% less calories than the regular 275ml bottle.
Public Health Minister Anna Soubry was delighted with the news that the drinks giants had gotten on-board with the Responsibility Deal, seeing it as a step in the right direction for the long-term plan to tackle obesity.

She said: “Being overweight and not eating well is bad for our health. To reverse the rising tide of obesity we have challenged the nation to reduce our calorie intake by 5 billion calories a day. On average that’s just 100 calories less a day per person. Today’s announcement will cut the calories and sugar by up to 10% in leading brands like Lucozade and Ribena. Through the Responsibility Deal we are already achieving real progress in helping people reduce the calories and salt in their diet. Overall, more than 480 companies including many leading high street brands have signed up to the Responsibility Deal. We are encouraged by the extra businesses which have signed up today but I want to see even more progress.  All in the food industry have a part to play and I now expect companies which are not yet taking action to come forward and make pledges.”

There are now 31 companies that have joined the governmental scheme including Coca-Cola GB, PepsiCo, Britvic, Asda, Tesco, Co-Operative Food and Burton’s Biscuits.

Unfortunately, not everybody welcomed the latest developments with a positive attitude. Charlie Powell of the Children’s Food Campaign said that the newer version of the popular drinks would still merit a red traffic light according to Food Standards Agency guidelines. He said: “So they are swapping one red light for another, not exactly impressive. Lots of companies making tokenistic commitments does not constitute effective action to tackle obesity – it is regrettable that the Department of Health is pushing a smoke-and-mirrors strategy which puts public health behind commercial interests.”