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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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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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Study affirms negative effects of Dengvaxia

by UNTV News and Rescue   |   Posted on Thursday, June 14th, 2018

The controversial anti-dengue vaccine, Dengvaxia

The New England Journal of Medicine published an article about the negative effects of the controversial anti-dengue vaccine, Dengvaxia to those who have not contracted the disease prior to inoculation.

According to the article entitled “Impact of Dengue Serostatus on Dengue Vaccine Safety and Efficacy,” the vaccine is effective in protecting the patient from a re-occurrence of dengue. However, to those without prior dengue infection, the vaccine is not recommended as it could lead to severe dengue.

The study focused on the analysis of the dengue vaccine manufactured by Sanofi Pasteur which is Dengvaxia. This means the research study is in conformity with the recommendation of the World Health Organization (WHO) in April that Dengvaxia should not be administered to children without prior exposure to dengue.

In November 2017, Sanofi Pasteur issued a warning saying there is very high possibility of contracting severe dengue if Dengvaxia is received by individuals without prior dengue infection.

Dengvaxia has been administered to nearly 800,000 children in the Philippines under the government’s Dengue immunization program. – UNTV News & Rescue

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Former P-Noy claims no direct proof on Dengvaxia-linked deaths

by UNTV News and Rescue   |   Posted on Tuesday, June 5th, 2018

FILE PHOTO: Former President Benigno Aquino III

MANILA, Philippines – Former government officials maintained no wrongdoings in relation to the Dengvaxia anomaly.

During the preliminary investigation of the Department of Justice Monday, June 4, former President Benigno Aquino III. former Health Secretary Janette Garin and former Budget Secretary Florencio Abad personally submitted their counter affidavits on the controversial P3.5 billion pesos worth of Dengvaxia immunization program.

Aquino, Garin, and Abad are facing complaints filed by the Volunteers Against Crime and Corruption (VACC) and Vanguard of the Philippine Constitution (VPC.)

Aquino stressed there were no categorical findings directly linking Dengvaxia as the cause of death of some vaccinees.

‘Iyong mga may threat supposed to be ng mga may severe dengue, is anywhere from 0.2-10 percent, so iyong proteksyon for the 90 (percent) and more, should be avoided,” explained Aquino.

He also addressed the issue on the questionable procurement of the said vaccines which allegedly coincided with the election ban in 2016.

“Kapag dumating iyong election campaign, election ban which was March 26 to May 9. Anyway…Siguro Iyong last na action na sinasabi natin na kaugnay sa..Siguro iyong pag-execute ng disbursement order which happened March 9. So March 9 and March 26.Medyo magkalayo,” he argued.

Garin, meanwhile, emphasized that the confirmation of the deaths of children who were autopsied failed to follow the World Health Organization’s (WHO) guidelines.

“Sa pag-determine ng causality kung ito ba ay namatay sa bakuna o hindi—may proseso na sinusunod ang WHO hindi po ine-exhume o ino-autopsy ang pasyente,” Garin said.

The Public Attorney’s Office (PAO), which conducted the autopsies, lashed out at Garin

“WHO rin ang basis naming sa determination ng cause of death. May WHO materials din ang PAO,” Acosta defended.

The next hearing will be on June 22. – Mai Bermudez

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