The first-ever vaccine against dengue fever, which affects up to 400 million people per year, has been cleared for use in Mexico, French manufacturer Sanofi said on Wednesday.
“It’s a very important moment in the history of public health,” Olivier Charmeil, head of the company’s vaccines division, told AFP, describing Dengvaxia as the “innovation of the decade”.
This vaccine could potentially become “a blockbuster” and generate more than a billion dollars in revenue for the French pharmaceutical company, Charmeil added.
It took 20 years and more than 1.5 billion euros ($1.6 billion) in research and development to create Dengvaxia.
Until now, scientists have been stumped by dengue which is caused by four separate viruses acting in concert.
The World Health Organization says dengue has become the fastest-growing mosquito-borne disease, with as many as 400 million people infected every year.
It can trigger a crippling fever, along with muscle and joint pain, and there is no known cure.
The deadliest form of the disease kills 22,000 people per year, the WHO says.
Over the past half-century, dengue has become endemic in more than 100 tropical and sub-tropical countries, thanks largely to rapid urbanisation.
Sanofi Pasteur has requested authorisation to push the vaccine in 20 countries.
“We are waiting for more registrations in Asia and Latin America in the coming weeks,” said Charmeil.
Several million doses of the vaccine are ready to ship, and Sanofi expects annual production to reach 100 million doses by 2017.
A stockpile for the European Union will be shipped in early 2016 and in the United States a year later.
Clinical tests — carried out on 40,000 people from 15 countries — have found Dengvaxia can immunise two-thirds of people aged nine years and older, rising to 93 percent for dengue hemorrhagic fever, reducing the risk of hospitalisation by 80 percent.
– RelaxNews
About Sanofi Pasteur’s dengue vaccine
Sanofi Pasteur’s vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine. Dengvaxia® successfully completed phase III clinical studies in 2014 to evaluate the primary objective of vaccine efficacy.7, 8
Long-term follow-up studies of the vaccine, recommended by WHO for all dengue vaccines in development, are currently ongoing. Additional pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were recently published in The New England Journal of Medicine reconfirming the vaccine’s consistent efficacy and longer-term safety profile in populations 9 years of age and older. In a pooled efficacy analysis in volunteers aged 9-16 who participated in the two Phase III 25-month efficacy studies, Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants. Furthermore, this pooled efficacy analysis showed that Dengvaxia® prevented 9 out of 10 cases of severe dengue and 8 out 10 hospitalizations due to dengue in this age group.9
Dengvaxia® is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced and full scale production capacity will be reaching 100 million vaccine doses annually.
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