Philippines orders probe into Sanofi dengue vaccine for 730,000 children


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MANILA (Reuters) – The Philippines ordered a probe on Monday into the immunisation of greater than 730,000 kids with a vaccine for dengue that has been suspended following an announcement by French drug firm Sanofi (SASY.PA) that it might worsen the illness in some instances.

FILE PHOTO: A emblem is seen in entrance of the doorway on the headquarters French drugmaker Sanofi in Paris October 30, 2014. REUTERS/Christian Hartmann/File Photograph

A non-governmental organisation within the Philippines mentioned it had acquired info that three kids who had been vaccinated with Dengvaxia in April 2016 had died, however Sanofi mentioned no deaths had been reported on account of the programme.

“So far as we all know, so far as we’re made conscious, there aren’t any reported deaths which can be associated to dengue vaccination,” Ruby Dizon, medical director at Sanofi Pasteur Philippines, instructed a information convention in Manila.

Final week, the Philippines’ Division of Well being halted using Dengvaxia after Sanofi mentioned it have to be strictly restricted as a result of proof it may possibly worsen the illness in individuals not beforehand uncovered to the an infection.

In an announcement issued within the Philippines, Sanofi defined the “new findings” however mentioned the long-term security analysis of the vaccines confirmed considerably fewer hospitalisations as a result of dengue in vaccinated individuals over 9 years previous in contrast with those that had not been vaccinated.

Almost 734,000 kids aged 9 and over within the Philippines have acquired one dose of the vaccine as a part of a programme that value three.5 billion pesos ($69.54 million).

The Division of Justice on Monday ordered the Nationwide Bureau of Investigation (NBI) to look into “the alleged hazard to public well being … and if proof so warrants, to file applicable expenses thereon.”

There was no indication that Philippines well being officers knew of any dangers once they administered the vaccination.

Nonetheless, the World Well being Group mentioned in a July 2016 paper that “vaccination could also be ineffective of could theoretically even improve the long run threat of hospitalised or extreme dengue sickness in those that are seronegative on the time of first vaccination no matter age.”

Singapore’s Well being Sciences Authority mentioned final week that it flagged dangers when the vaccine was accepted there in October 2016, and was working with Sanofi to strengthen threat warnings on the drug’s packaging.

In accordance with Sanofi in Manila, 19 licences had been granted for Dengvaxia, and it was launched in 11 international locations, solely two of which – the Philippines and Brazil – had public programmes to manage the vaccine.


A spokesman for Philippines President Rodrigo Duterte mentioned on Sunday the federal government would maintain to account these answerable for a programme that had positioned hundreds of lives in danger.

“We’ll depart no stone unturned in making these answerable for this shameless public well being rip-off which places tons of of hundreds of younger lives in danger accountable,” spokesman Harry Roque mentioned in an announcement.

Roque mentioned there had been no reported case of “extreme dengue an infection” because the vaccine was administered and known as on the general public “to not unfold info which will trigger undue alarm”.

Nonetheless, Volunteers Towards Crime and Corruption mentioned it was checking a report that three kids on the northern island of Luzon had died since being vaccinated in April 2016 and described the scenario as a catastrophe.

“We now have acquired info from our coordinator in central Luzon that three kids have died,” the group’s chairman, Dante Jimenez, instructed reporters.

“I‘m nonetheless having it verified, the names. If ever, they’ve already been buried … we’re asking the NBI to conduct an exhumation. That is actually critical.”

Dengue is a mosquito-borne tropical illness. Though it isn’t as critical as malaria, it’s spreading quickly in lots of elements of the world, killing about 20,000 individuals a yr and infecting tons of of hundreds of thousands.

Whereas Sanofi’s Dengvaxia is the first-ever accepted vaccine for dengue, scientists already recognised it was not good and didn’t shield equally in opposition to the 4 several types of the virus in medical exams.

A brand new evaluation from six years of medical information confirmed that Dengvaxia vaccine supplies persistent protecting profit in opposition to dengue fever in those that had prior an infection.

However for these not beforehand contaminated by the virus, extra instances of extreme illness might happen in the long run following vaccination upon a subsequent dengue an infection, Sanofi mentioned.

Extra reporting by Karen Lema in MANILA and by John Geddie in SINGAPORE; Writing by John Chalmers; Enhancing by Raju Gopalakrishnan

Our Requirements:The Thomson Reuters Belief Rules.

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