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WHO recommends testing before use of Sanofi’s dengue vaccine

by UNTV News   |   Posted on Friday, April 20th, 2018

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.

HEALTH SCARE

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.

COMMITTED

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

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Duterte to name experts picked to probe Dengvaxia mess: DOH

by UNTV News and Rescue   |   Posted on Friday, September 7th, 2018

Anti-dengue vaccine Dengvaxia

 

MANILA, Philippines —President Rodrigo Duterte has selected three experts to form the Asian panel who will investigate the effects of the controversial vaccine, Dengvaxia.

Health Secretary Francisco Duque said the information may likely be made public next week after the arrival of Duterte on Sunday (September 9) from his historic visit to Israel and Jordan.

Malacañang mentioned before that the President will pick three among the recommended experts from Vietnam, Thailand, Singapore, and Sri Lanka.

“Part of the presidential directive is, those members of the panel, the experts, must come from the countries where the Dengvaxia immunization program was also implemented,” said Duque.

He added that the investigation by the Asian panel of experts on Dengvaxia is expected to be completed as soon as possible.

Meanwhile, the Health Department expressed gratitude to Congress for passing the P1.161 billion supplemental budget.

“ We are very gratified and thanks to the House and the Senate for their most positive decision to pass and approve this bill,” he said.

This will be used to finance the medical needs of the children who were inoculated with Dengvaxia vaccine.

Secretary Duque noted that around 900,000 people were injected with the anti-dengue vaccine and most of them are children. – Rosalie Coz

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Congo Ebola outbreak not yet stabilized – WHO chief

by UNTV News   |   Posted on Thursday, August 30th, 2018

Congolese officials and the World Health Organization officials wear protective suits as they participate in a training against the Ebola virus near the town of Beni in North Kivu province of the Democratic Republic of Congo, August 11, 2018. REUTERS/Samuel Mambo

The number of Ebola cases in the Democratic Republic of Congo is on the decline, but it is too soon to say that an outbreak is stabilizing due to difficulties identifying new cases near rebel-controlled areas, World Health Organization (WHO) chief Tedros Adhanom Ghebreyesus said on Wednesday (August 29).

Some areas close to the outbreak’s epicenter in the town of Mangina are off-limits to health workers for security reasons, hampering efforts to control the spread of the disease.

“We need to be more aggressive. The virus doesn’t actually differentiate between a rebel and so on, it’s dangerous to everybody,” Tedros told Reuters on the sidelines of a news conference, adding that the next seven to ten days would be critical to controlling the outbreak.

Since the latest outbreak was declared on August 1, 112 confirmed and probable cases have been identified in eastern Congo’s North Kivu and Ituri provinces, including 75 deaths, according to overnight data from Congo’s health ministry.

Congo has experienced 10 outbreaks of Ebola since it was discovered in the country’s forested north in 1976. The disease causes hemorrhagic fever and usually kills about half of the people it infects. — Reuters

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DepEd, DOH launch mobile app for monitoring of Dengvaxia vaccinees

by UNTV News and Rescue   |   Posted on Tuesday, July 17th, 2018

MANILA, Philippines – Dengvaxia vaccinees can now be monitored digitally online and in real time by parents and guardians.

This is through a soon to be launched mobile apps called Abizo and Kaizala for Android, iOS and Microsoft phones.

The apps allow parents of vaccinees to report the condition of their children.

It aims to provide vaccinees a prompt response and immediate medical attention by the local government.

“ This is not mandatory… Parents who are interested in tracing and monitoring the state of their children, whether away from home or at school can take advantage of these two kind of apps,” explained Education Secretary Leonor Briones.

“If there’s a parent (who) downloaded the app and registered the name of his or her child, lalabas doon kaagad iyong names. If he provided the LRN then verified agad na siya iyong parent. If he didn’t provide, that report will be segregated then throwback again to DOH for validation. Kapag na-verify then we include them under the category of private sector,” added Education Undersecretary Alain Del Pascua.

The monitoring apps are also expected to help identify areas that have high incidence of Dengvaxia vaccinees who are getting sick.

“There are a checklist of symptoms that they can just say, may lagnat, pannakit ng ulo…madali na. Sasabihin na lang doon saan mo dadalhin iyong bata. Anong service delivery, part of the network mo siya dadalhin,” said Health Secretary Francisco Duque III.

The Department of Education (DepEd) and other stakeholders assured that the National Privacy Act will protect the data sharing between DepEd and the Department of Health (DOH) in using the mobile apps.

Parents may officially use the mobile apps at the end of August. – Aiko Miguel / UNTV News and Rescue

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