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
P-Noy fails to attend prelim probe on Dengvaxia complaint
Former President Benigno Aquino III
MANILA, Philippines – Former President Benigno Aquino III failed to show up Tuesday, May 15, in the preliminary investigation of the Department of Justice (DOJ) on the complaints filed against him in relation to the Dengvaxia controversy.
The complainants of the case include the Volunteers Against Crime and Corruption (VACC,) Vanguard of the Philippines Inc., and Atty. Manuelito Luna.
Among the respondents were former Finance Secretary Florencio Abad, former Health Secretary Janet Garin and former officials of the Department of Health (DOH.)
Those who did not attend were represented by their respective lawyers. Meanwhile, pharmaceutical giant Sanofi Pasteur, the manufacturer of Dengvaxia, did not send any representative.
Respondents are facing four different charges including violation of the Procurement Law, technical malversation, graft and criminal negligence.
They were given a copy of the complaint and advised to submit their respective counter-affidavits within the next 15 days.
The DOJ also obliged the respondents to attend the next hearing on June 4 at 10:00 in the morning to personally face inquiry. — Rey Pelayo |UNTV News & Rescue
PAO files 3 more Dengvaxia complaints vs. Duque, Garin
(L-R) former Health Secretary Janette Garin and current Health Secretary Francisco Duque III
MANILA, Philippines – The quest for justice for the victims of Dengvaxia continues as the Public Attorney’s Office today filed three more cases at the Department of Justice (DOJ.)
Respondents in the complaints include Health Secretary Francisco Duque III and former Secretary Janette Garin along with other Department of Health (DOH) officials and executives of Sanofi Pastuer and Zuellig Pharma.
The new cases stem from the deaths of Marc Axl Eboña, Rei Jazztine Alimagno and Alexzander Jaime. The PAO forensic team is convinced that their deaths were the result of Dengvaxia injections.
“Sa aming assessment, napatunayan na po kung ano po ang causes of deaths nitong mga batang halos sunod-sunod na namatay. Hindi po ito coincidental lang na 53 na po ang nao-autopsy ng pao na mayroong common pattern,” PAO Chief Persida Acosta said.
(In our assessment, the causes of deaths of these children who died one after another are already confirmed. This is not coincidental. The PAO found a common pattern in 53 [victims] subjected to autopsy.)
Analyn Eboña, the mother of Marc Axl pleaded with President Rodrigo Duterte to act on the issue.
“Hanggang ngayon hindi ko pa po naririnig ang tinig niyo, mahal na pangulo. Lalo na sa akin na ang aking anak ay naturukan nang walang pahintulot ng magulang,” she said.
(Up to now, I have not heard your voice, dear President. Especially in my case, my child was injected without parental consent.)
There are already 9 criminal complaints filed by PAO with the DOJ over the Dengvaxia mess. The preliminary investigation on the first cases will begin next Tuesday.
Acosta said, the President’s plan to create a panel of foreign experts to probe Dengvaxia deaths will not affect their cases. – Roderic Mendoza | UNTV News & Rescue
Graft charges filed anew vs. former PNoy over Dengvaxia mess
Former President Benigno Aquino III faces another complaint over the controversial dengue vaccine Dengvaxia.
QUEZON CITY, Philippines – The group, Citizens Crime Watch, filed malversation and graft charges against former president Benigno Aquino III before the Office of the Ombudsman on Thursday, May 10, over the purchase and use of Dengvaxia vaccine.
Among the respondents in the complaint are former Executive Secretary Paquito Ochoa, former Budget Secretary Butch Abad, former Health Secretary Janet Garin and 15 other former and current officials of the Department of Health (DOH.)
This is the third complaint filed against the former president in connection with the controversial vaccine.
The group’s president, Diego Magpantay, said that aside from being overpriced the procurement of the vaccine was done in haste. The group also accused the former officials of amassing over P50 million from the Dengvaxia immunization program.
The complainant also questioned the almost P500 million unliquidated amount from the P3.5 billion worth project of the government.
The group believes there was conspiracy among the accused and they have enough evidence to prove their claims. — Grace Casin | UNTV News & Rescue