FILE PHOTO: Boxes of anti-dengue vaccine Dengvaxia are placed inside a freezer for storage at the Manila Health Department in Sta Cruz, metro Manila, Philippines December 5, 2017. REUTERS/Romeo Ranoco
PARIS/CHICAGO (Reuters) – The World Health Organization (WHO) said on Thursday Sanofi’s vaccine against dengue should only be used after testing on individuals to assess whether they have ever been exposed to the infection.
After a two-day meeting in Geneva, Switzerland, experts at the U.N. agency recommended extra safety measures for the medicine, sold as Dengvaxia.
“We have now clear information that the vaccine needs to be dealt with in a much safer way by using it exclusively in people already infected with dengue before,” Alejandro Cravioto, Chair of the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization, told reporters.
“It requires for the people to be tested through a system that is not currently available but that we feel will be developed in the next years,” he said.
Sanofi said in a statement: “We are confident in Dengvaxia’s safety and its proven potential to reduce dengue disease burden in endemic countries.”
Sanofi also said it would “continue to work with the international public health community and endemic countries, to ensure the best usage of the vaccine.”
The French drugmaker warned in November that Dengvaxia, first approved in late 2015, could increase the risk of severe dengue in some cases in people who had not been previously exposed to the disease.
Mosquito-borne dengue is the world’s fastest-growing infectious disease, afflicting hundreds of millions of people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, annually.
Dengvaxia, the world’s sole licensed vaccine against dengue, is at the center of a health scare in the Philippines where the government suspended its use last year amid safety fears.
The company has repeatedly said it knows of no deaths resulting from the medicine.
Joachim Hombach, executive secretary of WHO’s SAGE group, said: “For us, the primary consideration is to assure our recommendation makes public health sense in terms of ensuring the use of vaccine will maximize public health benefit and minimize risk.”
“It is very important we signal ways in which this vaccine could be used,” he said, adding that it was up to the company to decide how to deal with this.
Hombach defended the WHO’s initial recommendation that the vaccine could be used in children aged 9 and older in places where 70 percent of the population had previously been exposed to the virus, and were likely to benefit from the vaccine.
He said the WHO pointed out a gap in data on the use of the vaccine in people who had never been exposed to the virus, and asked Sanofi to study the impact of the vaccine on children who had never been exposed to the virus.
That study resulted in Sanofi’s announcement last November.
Executives at Sanofi have denied any wrongdoing and insist on the benefits the medicine brings as a whole.
In a interview with Reuters last month, David Loew, head of Sanofi Pasteur, the group’s vaccines division, said Sanofi remained committed to Dengvaxia.
He added Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test, however, would take at least two years to bring to the market, he said.
Dengvaxia has been approved and registered in 19 countries and is currently under review by the European Medicines Agency.
Japan’s Takeda Pharmaceutical, the United States National Institute of Health and Brazil’s Butantan Institute are developing rival products.
Initially seen as potential $1-billion-a-year-plus product, Dengvaxia net sales stood at 3 million euros ($3.71 million) in 2017 as Sanofi was forced to buy back unused doses. The company took a charge of 87 million euros in the fourth quarter.
($1 = 0.8090 euros)
Editing by Jane Merriman
Congo’s Ebola outbreak to last at least six more months, WHO says
Health workers treating Ebola patient in treatment unit | REUTERS
The Ebola outbreak in northeastern Democratic Republic of Congo, which has already killed more than 200 people, is expected to last until mid-2019, a senior World Health Organization official said on Tuesday (November 13).
WHO emergency response chief Peter Salama said the WHO is “planning on at least another six months before we can declare this outbreak over.”
The outbreak in Congo’s North Kivu province has caused 333 confirmed and probable cases of the deadly virus and is now the worst in Congo’s history.
The location of the disease is perhaps the most difficult the WHO has ever encountered, due to a dense and mobile local population, insecurity caused by two armed groups, and its spread by transmission in health centers, Salama said.
One of the major drivers of the spread of the disease was due to people visiting the several hundred “tradi-modern” health centers in the town of Beni, he said. — Reuters
Poor air quality in India’s capital triggers health concerns
New Delhi in smog | REUTERS
Pollution levels in New Delhi, the capital of India, are over 50 times more than the allowed limits, raising people’s concerns over health especially for children.
Four-year-old Avyan suffers from severe wheezing and chest infections, which often leading to multiple hospitalizations. Although he is under the protection of air purifiers and anti-pollution masks, his mother still worries about his health condition because the pollution in the city shows no sign of improving.
“Whenever I put a mask on him for doing the nebulizer, every time some part of me inside me cries. Because once I am pumping him with all those strong medicines, just to manage those symptoms, the other is his body really needs that to survive in this environment. So we would want him to have a very nice happy healthy childhood, but it’s sad that we are not able to give him that, just because we’re in a place which has so much of pollution,” said Anchal Garg Karanth, mother of Avyan.
Recent studies have shown that one in every three children in Delhi has impaired lung function according to the Center of Science and Environment. Doctors also say newborn babies in Delhi take in gulps of polluted air equivalent to smoking 25 cigarettes on the first day of their lives.
According to the World Health Organization, over 100,000 children died below the age of five due to the air pollution in India in 2016, which is the record high in the world. Children are particularly vulnerable to bad air because they breathe more rapidly than adults and absorb twice as many pollutants.
“If you are not oxygenating very well, your cognitive function in terms of behavior, intelligence, has a major impact, especially if it happens in the younger years because that is when the neurological system is really developing. Other than that, any chronic lung issue can impact the cardiovascular system as well,” said Anupama Gupta, a pediatrician.
Delhi’s smog is said to be a toxic mix of vehicular pollution, construction dust, and fumes from crops burnt by farmers in neighboring states. This year, the Delhi government banned all construction, digging and excavation work when the pollution levels started rising. The government might also act by taking private cars off of Delhi’s roads if pollution levels deteriorate further.
“In emergency response, you are not really solving the problem, but what you are doing is you are stopping from adding more where the situation is already very bad. But the more fundamental solution will come when you are doing a round-the-year plan and with stringent implementation of that plan,” said Anumita Roy Chowdhary, an environmentalist.
The Indian government is currently working on a national clean air plan and has suggested it aims to reduce air pollution by 30 percent in the next five years. — Reuters