Philippines: Probe into Sanofi dengue vaccine

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.

A non-governmental organisation in the Philippines said it had received information that three children who were vaccinated with Dengvaxia in April 2016 had died, but 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," Ruby Dizon, medical director at Sanofi Pasteur Philippines, told a news conference in Manila.

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 issued in the Philippines, Sanofi explained the "new findings" but 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 (NBI) 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 World Health Organization said in a July 2016 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 the vaccine 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, only two of which – the Philippines and Brazil – had public programmes to administer the vaccine.

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 upon a subsequent dengue infection.

/theSTAR 04-12-2017

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Malaysia: Latest on Dengvaxia

The world’s first dengue vaccine Dengvaxia may have negative long-term effects on those who have never had a prior dengue infection, says Health Ministry Director General Datuk Dr Noor Hisham Abdullah.

He said a six-year clinical study found that although the vaccine was effective for those with a prior dengue infection, it was not so for those who had never been infected.

Dr Noor Hisham stressed that the Drug Control Authority is careful in the approval process of any pharmaceutical product registration.

“The Dengvaxia vaccine is not yet sold or used at any health facilities in Malaysia, be it in the public sector or in the private sector,” he said in a statement yesterday. “The product has also not been included as part of the Health Ministry’s National Immunisation Programme (NIP).”

His statement came in response to the suspension of Dengvaxia by the Philippines, which has vaccinated more than 700,000 children with Dengvaxia since 2016.

The Philippines is among the countries, including Mexico, El Salvador, Brazil, Singapore and Costa Rica, where Dengvaxia has been approved for marketing.

On Wednesday, French manufacturer Sanofi Pasteur disclosed that those who had never been infected with dengue could develop a more severe case if given the vaccine and had a subsequent infection.

Dr Noor Hisham said the Drug Control Authority has only approved a conditional registration in November last year for a two-year clinical study on the efficacy and safety of the drug.

“It is vital that the vaccines and medicines that Malaysians use are safe, effective and of good quality,” said Dr Noor Hisham, adding that no individuals have tried using Dengvaxia in Malaysia so far.

He also urged the public to check if a pharmaceutical product is registered by checking its hologram seal and that it is labelled with a legitimate product registration number.

The registration status of the pharmaceutical product could be checked on

Sanofi Pasteur global medical head Dr Su-Peing Ng said they are working with health authorities to ensure that prescribers, vaccinators and patients are “fully informed of the new findings”.

“Sanofi will propose that national regulatory agencies update the prescribing information, known as the label in many countries, requesting that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating,” the statement read.
/theSTAR 03-12-2107

Disclaimer: Views or opinions expressed are solely those of the Author and should be used with discretion. The Author shall not be held liable for any acts or omissions arising from the use of the information. The user will be personally liable for any damages or other liability arising hereof.

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