MANILA: The Philippines ordered a probe on Monday into the immunisation of more than 730,000 children with a vaccine for dengue that has been suspended following an announcement by French drug company Sanofi that it could worsen the disease in some cases.
Amid mounting public concern, Sanofi explained its “new findings” at a news conference in Manila, but it did not say why action was not taken after a World Health Organization (WHO) report in mid-2016 that identified the risk it was now flagging.
A non-governmental organisation (NGO) said it had received information that three children who were vaccinated with Dengvaxia had died and a senator said he was aware of two cases.
However, Department of Health Under-secretary Gerardo Bayugo said that the three referred to by the NGO died due to causes not related to the vaccine, and Sanofi said no deaths had been reported as a result of the programme.
“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” said Ruby Dizon, medical director at Sanofi Pasteur Philippines.
Last week, the Philippines Department of Health halted the use of Dengvaxia after Sanofi said it
must be strictly limited due to evidence it can worsen the disease in people not previously exposed to the infection.
In a statement, Sanofi said the long-term safety evaluation of the vaccines showed significantly fewer hospitalisations due to dengue in vaccinated people over 9 years old compared with those who had not been vaccinated.
Nearly 734,000 children aged 9 and over in the Philippines have received one dose of the vaccine as part of a programme that cost 3.5 billion pesos ($69.54 million).
The Department of Justice on Monday ordered the National Bureau of Investigation to look into “the alleged danger to public health... and if evidence so warrants, to file appropriate charges thereon.”
There was no indication that Philippines health officials knew of any risks when they administered the vaccination.
However, the WHO said in a July 2016 research paper that “vaccination may be ineffective or may theoretically even increase the future risk of hospitalised or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age.”
Singapore’s Health Sciences Authority said last week that it flagged risks when Dengvaxia was approved there in October 2016, and was working with Sanofi to strengthen risk warnings on the drug’s packaging.
According to Sanofi in Manila, 19 licences were granted for Dengvaxia, and it was launched in 11 countries, two of which — the Philippines and Brazil — had public vaccination programmes.
A spokesman for Philippines President Rodrigo Duterte said on Sunday the government would hold to account those responsible for the programme. — Reuters
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