August 13, 2016

Dengue Immunization Public Program in Paraná State of Brazil Set To Achieve WHO 2020 Ambition

 

Dengue Immunization Public Program in Paraná State of Brazil Set To Achieve WHO 2020 Ambition

– First dengue immunization public program in the Americas starts today targeting broad age range of individuals at highest risk of disease consistent with recent WHO position

– Paraná state will lead Dengue prevention in Brazil launching benchmark public program to immunize 500,000 individuals with Dengvaxia® dengue vaccine over next three weeks –

Paris, France – August 13th, 2016 – Sanofi and its vaccines global business unit Sanofi Pasteur announced that 500,000 doses of Dengvaxia® have been received in Paraná to support a large-scale public dengue immunization program initiated today in the State’s 30 most highly endemic municipalities.

Paraná State, home to 10 million people, has seen a steep 3-fold increase in both dengue incidence and deaths in recent years. In the last year, there have been 55,000 cases reported, costing the State an estimated R$ 330 million (~91 M Euro) in related healthcare expenses.

“For the public immunization program being launched today, we have used our extensive dengue surveillance data to ensure that we are targeting people at highest risk of disease. We will vaccinate all individuals 15-27 years of age in 28 municipalities and 9-44 years of age in the two municipalities with the top dengue burden in our State over the next three weeks,” said Michele Caputo Neto, Paraná Health Secretary.

Paraná has a good track record in vaccination coverage in general and successful implementation of this dengue immunization strategy could result in 74% reduction in disease burden in these highly impacted municipalities within 5 years, according to a dengue vaccine impact study published in the Brazilian Journal of Health Economics[i],” Secretary Neto noted.

Dr. Stephen J. Thomas, a physician-scientist at the Walter Reed Army Institute of Research in Silver Spring, Maryland who is an international dengue expert commented on the public immunization program initiated by Paraná State today. “Dengue remains one of the world’s most important mosquito transmitted diseases causing significant human suffering and financial cost. The strategic deployment of a safe and effective dengue vaccine offers the best hope of reducing dengue’s burden, especially in highly endemic countries like Brazil.”

Dengvaxia‘s safety and efficacy have been documented in a large clinical study program involving more than 40,000 people in studies conducted in 15 countries around the world including Brazil which participated in both phases II and III of the clinical development of the vaccine. The safety, efficacy and public health value of the dengue vaccine has been independently endorsed by the World Health Organization (WHO) in position paper on Dengvaxia published on 29th July 2016 [ii], which is consistent with the earlier positive recommendation on the dengue vaccine issued by the WHO’s Strategic Advisory Group of Experts on Immunization last April.

Guillaume Leroy, of Sanofi Pasteur, added “Introduction of the dengue vaccine first in endemic countries like Brazil has always been Sanofi Pasteur’s priority because this is where the vaccine can have the greatest impact on disease burden globally. Furthermore, successful implementation of Dengvaxia in a large-scale public program in Paraná will serve as a benchmark for dengue prevention efforts elsewhere in the country and in the world.”

Sanofi Pasteur will continue to address all supply demands coming from all clinics in Brazil, both public and private, as well as any additional requests from other countries supported by company’s ample dengue vaccine supply capacity from its production facility in France.

About Sanofi Pasteur commitment to public health in Brazil

Sanofi Pasteur is a leading vaccine provider in Brazil and a committed and longtime partner for public health in the country. Going back to 1974 the company produced and delivered 90 million doses of meningitis vaccine in record time to respond to an outbreak in Brazil. Sanofi Pasteur has partnered with the Butantan Institute in Brazil since 1999 to deliver seasonal influenza vaccines to the Brazilian population. In 2009 this partnership was instrumental in providing the pandemic A/H1N1 flu vaccine to the Brazilian government. In 2008, Sanofi Pasteur responded to a yellow fever outbreak in Brazil by delivering four million doses of yellow fever vaccine at the request of local health authorities and United Nation agencies. Since 2011, Brazilian infants have been receiving inactivated poliomyelitis vaccine provided via an agreement between Sanofi Pasteur and FIOCRUZ/ Biomanguinhos.

About Sanofi Pasteur Dengue Vaccine

In addition to Brazil, Sanofi Pasteur Dengue Vaccine is also registered in Mexico, Philippines, El Salvador and Costa Rica to date.  Regulatory review processes for Dengue Vaccine are continuing in other countries where dengue is a public health priority.

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.

A summary of the efficacy documentation on Dengvaxia for the study population 9 years and older population was published in The New England Journal of Medicine on July 27th 2015. These findings affirm the vaccine’s consistent efficacy in reducing dengue due to all four serotypes in two-thirds of the study participants 9 years and older and also documents the ability of the vaccine to prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases in this age group during the 25 month follow-up phase of the studies.[iii]

An integrated safety analysis was recently documenting Dengvaxia’s satisfactory safety profile comparable to placebo during the late stage clinical study program involving around 30,000 participants from 15 countries. In addition, the results of this analysis documented that the vaccine provided beneficial protection against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination compared to placebo in the study population 9 years and older.[iv]

Sanofi Pasteur Dengue Vaccine is the first vaccine licensed for the prevention of dengue in the world. The vaccine is supplied from a dedicated production site in France.

Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at www.dengue.info.


[i] Denizar V A, et al. Jornal Brasileiro de Economia da Saúde Brazilian Journal of Health Economics ABRIL 2016, VOLUME 8, NÚMERO 1 | APRIL 2016, VOLUME 8, NUMBER 1

[iii] Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206

[iv] Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: pooled analysis of data from 18 clinical trials.Gailhardou et al PLoS Negl Trop Dis. 2016 Jul 14;10(7):e0004821. doi: 10.1371/journal.pntd.0004821