PETALING JAYA: 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 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.