‘Anti-dengue drug approval should be expedited’

PETALING JAYA: The Health Ministry should expedite the approval of the world’s first anti-dengue vaccine after it received the nod from Singapore’s Health and Sciences Authority (HSA).

Universiti Malaya research consultant Prof Emeritus Datuk Dr Lam Sai Kit questioned the delay in approving the Dengvaxia vaccine, pointing out that the dengue situation in Singapore was similar to Malaysia’s.

“The sad thing is that we were offered this vaccine more than a year ago and the Health Ministry is still dragging its feet.

“Why must we always have to follow instead of lead?” asked Dr Lam who has been involved in dengue virology for over 40 years.

Dr Lam was a central figure in the discovery of the Nipah virus in late 1990s and instrumental in developing in-house rapid diagnostic techniques to detect the dengue virus.

The HSA’s decision to approve the Dengvaxia vaccine was based on 24 clinical studies carried out by Sanofi Pasteur – the company manufacturing the vaccine – which involved 41,000 people.

The vaccine was approved for use on people aged 12 to 45 years, as studies showed that the risk of hospitalisation from dengue was reduced in those above 12 years old, and not effective in those aged above 45. The HSA said it was prepared to revise its age guidelines when more data was available.

The vaccine is backed by the World Health Organisation’s Strategic Advisory Group of Experts. It is currently approved for use in Mexico, the Philippines, Brazil, El Savador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore. Previously, Health Ministry director-general Datuk Dr Noor Hisham Abdullah said the Drug Control Authority under the ministry had convened several meetings to review the data submitted by the manufacturer and would make a conclusion on the registration by mid-2016.

He said with the overall 65.6% efficacy of the vaccine, it would just be an additional tool in the multi-pronged approach to dengue prevention and control.

Asked about the concern over the vaccine’s low coverage and the possibility of severe dengue when a person is infected twice, Dr Lam said: “The age groups recommended by Singapore overcome these concerns. It follows the WHO guidelines.”

Dr Lam, a renowned medical virologist and the founding chairman of Asia Pacific Steering Committee for Dengue Vaccine to Vaccination Programme, added that the HSA’s guideline was clear and specified how the vaccine was to be used and the reasons it was used on selected age groups.

“I feel for those who suffered from dengue, and more so those who succumbed to it. How much longer to wait? How many more cases and deaths before they make a stand?,” he questioned.

Asked to comment on reports that the vaccine is less effective against the DENV-1 and DENV-2 strains of dengue, which are predominant strains in Singapore, Dr Lam said it was not a perfect vaccine but the data showed that it was good enough to be used alongside the usual vector control measures.