MANILA: The Philippines said Friday it had suspended use of a landmark vaccine for the potentially deadly dengue virus after its manufacturer warned it could worsen the disease in some cases.
Friday, 1 Dec 2017
- AFP file pic
French pharmaceutical giant Sanofi announced Wednesday (Nov 29) that its world-first dengue vaccine could lead to more severe symptoms for people who had not previously been infected.
The Philippines has vaccinated more than 700,000 children with Dengvaxia since 2016 when it became the first country to start using it on a mass scale.
But it said Friday the programme had been suspended.
Sanofi had initially said its Dengvaxia vaccine was “critical” in the fight against dengue, the world’s most common mosquito-borne virus.
It said Wednesday that a new study has confirmed Dengvaxia’s benefits for “those who had prior infection”.
“For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” Sanofi said.
The Philippine government stressed it had not yet received reports of any problems with Dengvaxia.
“Currently, there is no reported case of severe dengue infection among those who received the vaccine,” its statement said.
More than 1,000 people in the Philippines died from dengue last year, out of 211,000 suspected cases, according to the government. - AFP
https://www.thestar.com.my/news/regional/2017/12/01/philippines-suspends-world-first-dengue-vaccine/Malaysia Ministry warns of effects of Dengvaxia
PETALING JAYA: The world’s first dengue vaccine Dengvaxia may have negative long-term effects on those who have never had dengue infection, says Health Ministry director-general Datuk Dr Noor Hisham Abdullah.
Sunday, 3 Dec 2017
He said a six-year clinical study found that although the vaccine was effective for those with 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.
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 also be checked on http://npra.moh.gov.my.
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.
https://www.thestar.com.my/news/nation/2017/12/03/ministry-warns-of-effects-of-dengvaxia-antidengue-vaccine-could-lead-to-more-severe-illness-for-thos/
