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World's first malaria vaccination approved

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Having lived in Western part of Africa I have experienced the suffering of the common man...The Malaria parasite attacks its prey without any inhibitions...No exceptions including expats (LOL)..My family was hospitalized twice in a span of 1 year...

World's first malaria vaccination approved

European regulators give Mosquirix the green light to be used on babies at risk of the mosquito-borne disease in Africa.

24 Jul 2015


More than 80 percent of malaria deaths are in children under the age of five with most in Sub-Saharan Africa [EPA]The world's first malaria vaccine has received a green light from European drugs regulators who recommended it should be licensed for use in babies in Africa who are at risk of the mosquito-borne disease.


The shot, called RTS,S or Mosquirix, would be the first licensed human vaccine against a parasitic disease and could help prevent millions of cases of malaria in countries that use it.


The vaccine was developed by British drugmaker GlaxoSmithKline (GSK) in partnership with the PATH Malaria Vaccine Initiative, Recommendations for a drug licence made by the European Medicines Agency (EMA) are normally endorsed by the European Commission within a couple of months.

Mission Malaria


Mosquirix, also part-funded by the Bill & Melinda Gates Foundation, will also now be assessed by the World Health Organisation, which has promised to give its guidance on when and where it should be used before the end of this year.


Malaria killed an estimated 584,000 people in 2013, the vast majority of them in sub-Saharan Africa.


More than 80 percent of malaria deaths are in children under the age of five.
Andrew Witty, GSK's chief executive, said EMA's positive recommendation was a further important step towards making the world's first malaria vaccine available for young children.


"While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most," he said in a statement.


'Enormously significant '


Global health experts have long hoped scientists would be able to develop an effective malaria vaccine, and researchers at GSK have been working on RTS,S for 30 years.

Hopes that the shot would be the final answer to wiping out malaria were dampened when trial data released in 2011 and 2012 showed it only reduced episodes of malaria in babies aged 6-12 weeks by 27 percent, and by around 46 percent in children aged 5-17 months.

EMA's recommendation is that the shot should nevertheless be licensed for use in babies in the full age range covered in the trials - from 6 weeks to 17 months.

Some malaria specialists have expressed concern that the complexities and potential costs of deploying this first vaccine when it only provides partial protection make it less attractive and more risky.


However, Joe Cohen, a GSK scientist who has led the development of Mosquirix since 1987, said on Friday he had no doubt the vaccine could significantly reduce the toll of sickness and death caused by the malaria among African children.


"I have absolutely no reservations in terms of rolling this vaccine out," he told Reuters.

"Why? Because the efficacy, when translated into cases averted and deaths averted, is just tremendous. It will have an enormously significant public health impact."

http://www.aljazeera.com/news/2015/07/world-malaria-vaccination-approved-150724055510421.html
 
World's first malaria vaccine developed, EU body recommends license

World's first malaria vaccine developed, EU body recommends license

24 Jul 2015

London: The European Medicines Agency has recommended approving what would be the world's first licensed malaria vaccine, even though it's only about 30 percent effective and its protection fades over time.


In a statement Friday, the agency endorsed the vaccine's use outside Europe, a regulatory process that helps speed new medicines to the market.


The recommendation to license the vaccine, known as Mosquirix and made by GlaxoSmithKline, must still be approved by the European Commission.


The World Health Organization will next consider the evidence and recommend how the shot be used. It's unlikely donors would pay for the vaccine without WHO's guidance, especially since it only protects about one-third of the children vaccinated.


"This is not the big game-changer that we were hoping for," said Dr. Martin De Smet, a malaria expert at Doctors Without Borders. "The vaccine itself remains disappointing but this is an important step forward."


Still, De Smet said the vaccine could help reduce the huge burden of malaria, which sees 200 million new cases and more than 500,000 deaths every year, mostly in African children.


"In countries where children get four to six episodes of malaria a year, this will make a big difference," he said, adding that people should still keep using bed nets to protect against mosquitoes.


Gregory Hartl, a WHO spokesman, said the agency will issue its assessment by November and will review other factors not considered by the European regulator, including cost-effectiveness. GlaxoSmithKline had previously said they would sell the vaccine at cost value, although that doesn't include the logistics of vaccination programs — a full course includes four doses.


De Smet suggested the vaccine would be useful in high-malaria countries even though it's "highly imperfect."


Several other malaria vaccines are in development but none have produced better results.


http://www.indiatvnews.com/news/world/world-first-malaria-vaccine-developed-25644.html
 
Path is funded by the Bill and Melinda Gates Foundation, which poured more than $200 million into the project. GSK said it has spent more than $365 million on the effort. GSK said it will not make a profit from the vaccine. Its price would cover the manufacturing costs and a small return that would be reinvested in malaria research.
The vaccine is not yet licensed in countries where malaria is endemic, and the WHO says 2017 is the soonest that could happen.

http://money.cnn.com/2015/07/24/news/malaria-vaccine-bill-gates/index.html?section=money_topstories
 
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