Though the Ministry of Health (MOH) has approved a two-year conditional registration for the dengue vaccine to be used in Malaysia, it will not be incorporated into the National Immunisation Programme and will therefore not be provided for free in government health facilities, said Health director-general Datuk Dr Noor Hisham Abdullah.

“We have made a stand that it won’t be in our National Immuni¬sation Programme,” he said. “But it (the vaccine) is available.”

Dengue vaccine approved for Phase IV study in Malaysia

The National Pharmaceutical Regulatory Authority (NPRA) recently announced that the dengue vaccine will be allowed for use in Phase IV clinical trials for two years involving volunteers aged nine to 45, in order to assess the vaccine’s effectiveness and safety.

The MOH had vetted and decided on the conditional approval of the vaccine last October, but with strict conditions to monitor long term risks, safety and efficacy over a wider population.

“Dengvaxia is approved by DCA (Drug Control Authority) only for post-registration (Phase IV) study in Malaysia. This conditional registration is for two years,” said the NPRA. “If the study fails to verify the clinical benefits or are not conducted with due diligence, DCA may withdraw this approval.”

The vaccine’s producer, Sanofi Pasteur, has welcomed the MOH’s decision to approve conditional registration of the vaccine and will collaborate with relevant stakeholders, including the Health Ministry, to monitor the impact of the vaccine in the country.

“With this approval, Malaysians across the country will now have access to an additional form of protection against this debilitating, and sometimes, deadly disease,” said the company.

MOH to closely monitor side effects of vaccine

According to statistics from the Health Ministry, a total of 14,513 cases of dengue infection have been reported nationwide from January until 25 February 2017. While the numbers show a 43% decrease compared to the same time period in 2016, dengue remains a serious health concern in the country.

The dengue vaccine is currently approved in 14 other countries, including Singapore, Indonesia, the Philippines and Thailand, with Mexico being the first country to approve licensing of the vaccine in December 2015.

Nonetheless, the ministry is closely monitoring any possible side effects from the vaccine, as earlier data from the MOH revealed adverse effects in individuals who have never had dengue before, said Noor Hisham.

“Once they get the vaccination, they develop severe dengue. They can get dengue shock syndrome. It is possible,” he explained. "This is the reason there are a few conditions we have put in place.” MIMS

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