Philippines orders probe into Sanofi dengue vaccine for 730,000 children
MANILA (Reuters) – 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 Undersecretary Gerardo Bayugo told Reuters 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 SHAMELESS SCAM”
A spokesman for Philippines President Rodrigo Duterte said on Sunday the government would hold to account those responsible for the programme.
“We will leave no stone unturned in making those responsible for this shameless public health scam, which puts hundreds of thousands of young lives at risk, accountable,” spokesman Harry Roque said in a statement.
Former Health Secretary Janette Garin, who implemented the programme under the administration of then-President Benigno Aquino, said she welcomed the investigation.
“In the event that there will be authorities who will point culpability to me, I am ready to face the consequences,” she told ANC TV. “We implemented it in accordance with WHO guidance and recommendations.”
Roque said there had been no reported case of “severe dengue infection” since the vaccine was administered and urged the public “not to spread information that may cause undue alarm”.
Volunteers Against Crime and Corruption, an NGO, said it was checking a report that three children on the northern island of Luzon had died since being vaccinated in April 2016, but the Department of Health said the deaths were not due to Dengvaxia.
“When we evaluated the clinical records, it was not related to the dengue vaccination,” Undersecretary Bayugo said.
A prominent senator, Richard Gordon, told Reuters he was aware of two deaths – but gave no details – and said approval and procurement for the programme was done with “undue haste”.
Dengue is a mosquito-borne tropical disease. Although it is not as serious as malaria, it is spreading rapidly in many parts of the world, killing about 20,000 people a year and infecting hundreds of millions.
While Sanofi’s Dengvaxia is the first-ever approved vaccine for dengue, scientists already recognised it was not perfect and did not protect equally against the four different types of the virus in clinical tests.
A new analysis from six years of clinical data showed that Dengvaxia vaccine provides persistent protective benefit against dengue fever in those who had prior infection.
But for those not previously infected by the virus, more cases of severe disease could occur
in the long term following vaccination, Sanofi said.