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Friday, June 15, 2018

Yellow fever: A new method for testing vaccine safety, June 2018

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IMAGE: THIS IS A BBB-MINIBRAIN TRICULTURE.view more 
CREDIT: © MARIE-CHRISTINE CUMONT AND MONIQUE LAFON - INSTITUT PASTEUR
Scientists from the Institut Pasteur, the CNRS and Sanofi Pasteur have recently developed a novel alternative method to animal testing that can be used to verify the safety of vaccines such as the yellow fever vaccine. This original approach is based on the development of an in cellulo device using a 3D culture model, the "BBB-Minibrain", to evaluate the safety of live vaccines for human use. The model was developed by the Institut Pasteur and a patent application has been filed by the Institut Pasteur and Inserm. It raises hopes for a reduction in the use of animals in quality control, especially in the tests carried out by the pharmaceutical industry to meet the requirements of regulatory authorities. The results of this research were published in the journal Biologicals in May 2018, and online on March 24th.
For several years now, following the adoption of EU Directive 2010/63/EU,1 the scientific community has been actively seeking to reduce the practice of animal testing. But in many cases, these efforts are hindered by a lack of acceptable alternatives that satisfy regulatory authorities. This is particularly the case for the regulatory testing required for live viral vaccines, such as the yellow fever vaccine; suppliers must demonstrate that the seed lots used to produce vaccine batches sold on the market do not represent a risk of neurotoxicity. These tests are currently performed on animals, which are monitored for the emergence of any clinical signs in the central nervous system that may suggest neurotoxic side effects.
Against this backdrop, Institut Pasteur scientists developed a 3D culture model mimicking the human blood-brain interface, the "BBB-Minibrain", in 2014. This model, formed of a blood-brain barrier (BBB) associated with a mixed culture of neurons, astrocytes and microglia (a "minibrain"), can be used to detect when viruses enter the brain through the BBB, their multiplication in the minibrain and the emergence of any neurotoxic effects. A patent application (WO2016038123) was filed for the model.
The scientists set out to test the BBB-Minibrain's ability to pinpoint and amplify any rare mutant particles with neuroinvasive and neurovirulent properties that are found in seed lots for live viral vaccines. They chose to use two yellow fever virus vaccine strains, including the strain currently used to produce the vaccine, which does not cause neurotoxicity.
Working with Sanofi Pasteur research teams, they demonstrated that the BBB-Minibrain can be used to identify any rare viral particles in vaccine preparations that have acquired the ability to enter the brain and multiply there. This test therefore paves the way for the rejection of any seed lots containing mutant viruses capable of entering the brain and becoming neurovirulent.
As Monique Lafon, lead author of the study and Director of the Virology Department at the Institut Pasteur, explains, "replacing animal testing is a major challenge for research. The BBB-Minibrain model is an ingenious tool that will facilitate our analysis of the basis for neurovirulence in these viruses, which colonize the brain via the bloodstream."
These findings represent a first proof of concept and feasibility for the development of an alternative test that complies with the "3Rs" principle. Work to develop this test is ongoing. The long-term aim is to secure approval for the new test from regulatory authorities.
The BBB-Minibrain model raises hopes for the development of an alternative method that can be used by the pharmaceutical industry to perform regulatory tests on live viral vaccines. The aim of this method is to reduce the use of animals while ensuring strict monitoring of any scientific benefits and breakthroughs in the area of human health.

Friday, March 30, 2018

Brazil faces new yellow fever outbreak – and questions over lack of preparedness

Brazil faces new yellow fever outbreak – and questions over lack of preparedness

The country plans to vaccinate its entire population against the lethal mosquito-borne disease but specialists doubt its capacity to do so
Manuel de Freitas removes his shirt to expose his arm as a health worker fills a syringe with a yellow fever vaccine in Casimiro de Abreu, Brazil, last year.
 Manuel de Freitas exposes his arm as a health worker fills a syringe with a yellow fever vaccine in Casimiro de Abreu, Brazil, last year. The country is facing its second outbreak in consecutive years. Photograph: Leo Correa/AP
As it struggles to control its second deadly yellow fever outbreak in consecutive years, Brazil’s government has said it will vaccinate everyone in this continent-sized country who is not already protected – which means giving injections to 77 million people by the end of 2019.
But although Brazil already recommends yellow fever vaccines in many areas of 23 of its 27 states, it has not been able to deliver on those recommendations, leaving many unprotected.
That has raised concerns from health specialists over whether Brazil can produce all the vaccine it needs in time – even though it is one of only four producers supplying the vaccine to the World Health Organisation.
And it has provoked fresh questions over why the country failed to stop the disease spreading after last year’s outbreak.
Alberto Chebabo, an infectious diseases specialist at the Hospital Universitário Clementino Fraga Filho, part of Rio’s Federal University, said the authorities failed to follow through after initially mobilising to control the 2017 outbreak.
“We did not see the need at that moment to vaccinate the whole population in a rush,” he said.
Another issue is that responsibility for vaccinations is shared across a complex array of federal, state and local governments who don’t always communicate well, said Alba Ropero, regional adviser for immunisation for the Pan-American Health Organisation and WHO in Washington, and many ordinary Brazilians, mostly men, were reluctant to be vaccinated.
“There was a co-responsibility on different levels,” she said.
Transmitted by mosquitoes, yellow fever can be fatal in 15-50% of cases. In the early 20th century, Brazilian cities were blighted by the disease but by 1942, Brazil had seen its last case of urban yellow fever.
Cyclical outbreaks of “sylvatic” yellow fever – in which mosquitoes transmit the virus to humans from infected forest monkeys – caused a few dozen cases every year.
Brazil plans to vaccinate 77 million people against yellow fever by the end of 2019 but health specialists doubt it can produce enough vaccine in time.
 Brazil plans to vaccinate 77 million people by the end of 2019 but specialists doubt it can produce enough yellow fever vaccine in time. Photograph: Miguel Schincariol/AFP/Getty Images
Then, in January 2017, yellow fever began spreading from the forests of Minas Gerais, a sprawling rural state, towards Brazil’s populous south-east, leaving hundreds of dead monkeys in its wake.
Minas Gerais declared an emergency. Brazil organised vaccination campaigns and public information adverts, and queues formed outside health centres in big cities like Rio de Janeiro, where some ran out of vaccines.
But fears that the disease could spread from forest mosquitoes to the Aedes aegypti mosquitoes that thrive in big cities were not realised. And as cases fell in the winter, last September the health minister, Ricardo Barros, said the outbreak was over.
In January yellow fever returned – and this time it was more deadly. From July 2017 to 20 March 2018, there have been 1,098 cases and 340 deaths. And Barros has come under fire.
“It was very predictable,” said Maurício Nogueira, president of the Brazilian Virology Society and an infectious diseases specialist.
Specialists pointed to failures at all level of government. Vaccinations for yellow fever have been recommended in Minas Gerais for over a decade. Yet only half the population of 21 million was protected when the outbreak began there in January 2017 – even less in some of the isolated rural towns where it was concentrated.
Last year, the state saw 475 cases and 162 deaths. It has now vaccinated nearly 9 million people, said Rodrigo Said, state under-secretary of epidemiological vigilance, stressing the difficulties of reaching dispersed, rural populations. “It is a very difficult, onerous job,” he said.
Yet since December the state has seen another 396 cases and 137 deaths. “The numbers speak for themselves,” said Jessé Alves, an infectious diseases specialist at the Emilio Ribas hospital in São Paulo.
As the virus edged closer to Rio de Janeiro last March, authorities said they would vaccinate 90% of the state’s 16 million people by year end. It vaccinated less than a third of them. In 2016 Rio saw 27 cases and nine deaths, this year it has already had 179 cases and 67 deaths.
Last August São Paulo state began vaccinating “ecological corridors”, anticipating the virus’s spread. Adopting the WHO guidelines for controlling outbreaks, the state also split up, or “fractioned”, doses to provide cover for at least a year, instead of a decade.
“We did not take our foot off the accelerator,” said Regiane de Paula, director of the state’s epidemiological vigilance centre. Half the population is now protected, she said.
But since 2017 the state has seen 345 cases and 125 deaths. And whatever measures the authorities took, Nogueira said, “it was clearly not sufficient”.

Thursday, March 22, 2018

Yellow Fever in Brazil, March 2018 - CDC

Key Points

  • There is a large, ongoing outbreak of yellow fever in multiple states of Brazil. Since early 2018, a number of unvaccinated travelers to Brazil contracted yellow fever; many of these travelers were infected on the island of Ilha Grande (Rio de Janeiro State). Several have died.
  • Travelers to Brazil should protect themselves from yellow fever by getting yellow fever vaccine at least 10 days before travel, and preventing mosquito bites.
  • In addition to areas in Brazil where yellow fever vaccination has been recommended since before the recent outbreaks, the vaccine is now also recommended for people who are traveling to or living in: All of Espirito Santo State, São Paulo State, and Rio de Janeiro State as well as a number of cities in Bahia State.
  • People who have never been vaccinated against yellow fever should avoid traveling to areas of Brazil where yellow fever vaccination is recommended.
  • Travelers going to areas with ongoing outbreaks may consider getting a booster dose of yellow fever vaccine if it has been 10 or more years since they were vaccinated.
  • Yellow fever vaccine is available at a limited number of clinics in the United States, so travelers should plan ahead to get the vaccine.

What is yellow fever?

Yellow fever is caused by a virus that is spread through mosquitoes. Symptoms of yellow fever (fever, chills, headache, backache, and muscle aches) take 3–6 days to develop. About 15% of people who get yellow fever develop serious illness including bleeding, shock, organ failure, and sometimes death.

What is the current situation?

In early 2017, the Brazilian Ministry of Health reported outbreaks of yellow fever in several eastern states, including areas where yellow fever was not traditionally considered to be a risk. Since the end of 2017, yellow fever cases have reoccurred in several states, especially in the states of Rio de Janeiro, Minas Gerais, and São Paulo, including areas close to the city of São Paulo.
In early 2018, a case of yellow fever was reported in an unvaccinated Dutch traveler who had stayed near the São Paulo metropolitan region. Since then, there have been reports of other unvaccinated travelers to Brazil who visited areas with yellow fever outbreaks and contracted yellow fever; many of these travelers were infected on the island of Ilha Grande (Rio de Janieiro State). Several of these travelers died. None were from the United States.
In response to the outbreak that began in early 2017, the World Health Organization has expanded the list of areas where yellow fever vaccination is recommended for international travelers to Brazil.
In addition to areas in Brazil where yellow fever vaccination has been recommended since before the recent outbreaks, the vaccine is now also recommended for people who are traveling to or living in:
  • All of Espirito Santo State
  • All of São Paulo State, the city of São Paulo and all coastal islands
  • All of Rio de Janeiro State, including the city of Rio de Janeiro and all coastal islands
  • A number of cities in Bahia State
State of Bahia: new areas in which yellow fever vaccination is recommended for travelers Expandexpand Collapse

Expanded Yellow Fever Vaccine Recommendation Areas in Brazil


The Brazilian Ministry of Health maintains a regular list of all other cities in Brazil for which yellow fever vaccination has been recommended since before the recent outbreaks. This list does not include recently added areas above. It is located at http://portalsaude.saude.gov.br/images/pdf/2015/novembro/19/Lista-de-Municipios-ACRV-Febre-Amarela-Set-2015.pdf.

What can travelers do to prevent yellow fever?

Get yellow fever vaccine

  • Yellow fever vaccine is the best protection against yellow fever disease, which can be fatal. Anyone 9 months or older who travels to areas where yellow fever vaccine is recommended should be vaccinated against yellow fever at least 10 days before travel. For most travelers, one dose of yellow fever vaccine provides long-lasting protection. However, parts of Brazil are currently higher risk because of the outbreak. Travelers may consider getting a booster dose of yellow fever vaccine if traveling to areas with yellow fever outbreaks and it’s been 10 or more years since they were vaccinated. Areas with outbreaks include the states of Rio de Janeiro, Minas Gerais, and São Paulo.
People who have never been vaccinated against yellow fever for any reason should avoid traveling to areas of Brazil where yellow fever vaccination is recommended.
Yellow fever vaccine is currently available at only a limited number of clinics in the United States. Travelers should contact a yellow fever vaccine provider well in advance of travel. Search for a yellow fever vaccine provider near you.
Yellow fever vaccine is not recommended for some people. Talk with a health care provider if you have questions about the yellow fever vaccine.

Prevent insect bites

Because yellow fever and other diseases are spread by mosquito bites, all travelers to Brazil should prevent mosquito bites by using insect repellent, wearing long-sleeved shirts and pants when outdoors, and sleeping in an air-conditioned or well-screened room or under an insecticide-treated bed net.

If you get sick during or after travel

Talk to a doctor or nurse if you get sick, especially if you have a fever. Tell them you have been in a country with yellow fever.

Additional Information

Clinician Information

Saturday, March 10, 2018

Sarah Storey pulls out of Track World Championships over yellow fever fears in Brazil

  • Paralympic champion unable to be vaccinated while breastfeeding
  • ‘The health and wellbeing of my family is far more important’
Sarah Storey
 Sarah Storey will not return to Rio, where she won three golds in 2016, after advice on yellow fever vaccination following an outbreak of the disease in Brazil. Photograph: Andrew Matthews/PA
The 14-time Paralympic champion Dame Sarah Storey has withdrawn from the Great Britain team for the Para-cycling Track World Championships in Rio later this month.
The 40-year-old announced her decision on Thursday, following advice regarding yellow fever vaccination after an outbreak of the disease in Brazil.
Storey gave birth to her son Charlie last year and the four-and-a-half-month-old is breastfed, which means neither mother nor baby can be vaccinated, she said. 
“I am obviously disappointed to not be able to compete at the event and miss out on the opportunity to win another rainbow jersey but the health and wellbeing of my family is far more important,” Storey said.
“I am not prepared to risk travelling unvaccinated as contracting the infection results in a high percentage of fatalities.”
Storey won three Paralympic gold medals in Rio in 2016 following the birth in 2013 of daughter Louisa.
The Para-cycling Track World Championships take place from March 22 to 25.