A vaccine against dengue already existed and was also available in Europe. But soon there will also be another one, capable of triggering a more effective immune response. And above all to protect a wider range of the population: from infancy to cover the entire adult range and the third age. In its usual monthly appointment, the European Medicines Agency’s Committee for the Approval of Medicines for Human Use (CHMP) has given the green light to a new drug for the prophylaxis of dengue. It is a vaccine developed with the live attenuated virus and able to protect children and adults from the four most common serotypes.
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More than for its effectiveness, the incoming vaccine is considered valuable for the extension of the age group in which it will be possible to administer it: from 4 years old and even beyond 45. Therefore, beyond the range (6-45 years) for which Dengvaxia (Sanofi Pasteur), the only vaccine available against dengue so far, has been authorized since 2018. On one condition: that you have already contracted the infection at least once in your life.
Dengue fever: what is it?
Viral disease is transmitted by such mosquitoes Temples of the Egyptians (the same ones that transmit the Zika virus and Chikungunya) and manifests itself first of all with the fever (even high) that appears a few days after the insect bite. The infection is almost never fatal, but the symptoms are significant: high fever, severe headache, eye pain, joint pain, rash and reduction of white blood cells. Some severe cases can lead to hemorrhagic fever or anaphylactic shock. The largest number of dengue cases is recorded in tropical and subtropical regions: especially in urban and semi-urban areas.
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Every year, according to statistics from the World Health Organization, about 390 million people are affected worldwide. The disease almost always has a benign course in healthy people. While management can be complicated if those who have been bitten by mosquitoes – there is no human-to-human infection – suffer from chronic cardiovascular disease, asthma or diabetes. The number of victims fluctuates between twenty and twenty five thousand every year. A low overall figure. But among them there are mostly children. This is because the initial symptoms, in pediatric age, may be absent or in any case be very nuanced. Hence the difficulty in formulating a correct diagnosis and the greater probability of evolution towards the hemorrhagic form, characterized by recurrent bleeding (especially from the nose, gums and intestine).
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The massive spread recorded in recent decades, also due to the lack of prevention campaigns aimed at insects in the countries most affected by the infection, has prompted the World Health Organization to include dengue among the top ten health emergencies globally. Thanks to the increase in temperatures and the migrations of mosquitoes, the infection has also become more frequent in Western countries. And it is the second cause of fever, after malaria, which is recorded among travelers returning from countries such as India, Thailand, Indonesia, Mexico and Brazil. Hence, also due to the absence of effective antivirals, the decision of the EMA to expand prophylaxis against this disease. The new vaccine, developed by Takeda, can be administered to anyone who will be considered at risk. Provided they are over four years of age.
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The novelties consist in the widening of the age group and in the overcoming of the limit that saw the drug on the market administrable only to those who had already contracted the infection once: since they are more at risk of developing a severe form, in case of new contagion. The green light of the EMA came after evaluating the results of 19 clinical studies involving over 27 thousand people: from children of just over a year to the elderly. The vaccine was found to be effective in preventing the onset of fever and more severe forms of the disease. The side effects? Those most often associated with vaccines: injection site and muscle pain, headache and asthenia. Now it will be up to the regulatory agencies of the individual countries – AIFA, for Italy – to decide whether to offer it or not. And to which categories of the population, if any. The decision is expected by the end of the year.
From the EMA a green light also for the rest of the world
The dengue vaccine is the first drug that the EMA approves. An initiative resulting from the “EU-Medicines for All” program, developed with the World Health Organization to speed up the marketing practices of drugs considered essential in other areas of the world. The green light will thus allow Takeda to immediately start distributing the vaccine even in non-European countries interested in having the new drug available. Without having to undertake a new authorization process with another regulatory agency. This process is currently only possible for the marketing authorization of vaccines or life-saving drugs capable of responding to a public health emergency. A case that could concern, for example, the development of new molecules effective against HIV, malaria and tuberculosis. Or useful in ensuring the recovery of mothers and children from other infections that could jeopardize their survival. One of the most effective examples of collaboration in the name of global health, which has been talked about so much for over two years now.
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