KUALA LUMPUR, April 7 — Putrajaya has approved a two-year conditional registration for the world’s first dengue vaccine, amid controversy over its efficacy and side effects in certain conditions.
In a notice posted on the National Pharmaceutical Regulatory Authority’s (NPRA) website, the Dengvaxia vaccine will be allowed to be used in Phase IV clinical trials which among others seek to study its safety, long term risks, and its efficacy over a wider population.
NPRA said the decision to register the vaccine developed by Sanofi Pasteur, the vaccine unit of French pharmaceutical firm Sanofi, was made during two meetings in Putrajaya on October 31 and November 25 last year.
“Dengvaxia was approved by DCA only for post-registration It is a conditional registration for two years. Dengvaxia is approved by DCA only for post-registration (Phase IV) study in Malaysia. This conditional registration is for two years.
“If the study fails to verify the clinical benefits or are not conducted with due diligence, DCA may withdraw this approval,” NPRA said, listing the specific registration conditions imposed on Dengvaxia.
In the notice, NPRA said Sanofi Pasteur must also commit itself to conducting a joint study with the Health Ministry (MOH) in order to assess the vaccine’s effectiveness and safety. The study details will be further discussed by both parties.
“The post-registration study design, safety monitoring system and other related conditions will be jointly developed by MOH and Sanofi Pasteur,” NPRA said, adding that the company would also commit itself to supporting the ministry in its effort to educate the public about the vaccine.
In a statement run by daily The Star today, Sanofi’s Malaysian branch welcomed the decision and pledged to collaborate with relevant stakeholders in educating the public and monitoring the impact of dengue vaccination here.
“With this approval, Malaysians across the country will now have access to an additional form of protection against this debilitating, and sometimes, deadly disease,” the firm said.
Dengvaxia was developed by Sanofi Pasteur which had been researching the tropical disease for over 20 years, spending some €1.5 billion (RM7 billion) on it as well as on manufacturing investments.
As of February this year, 14 countries have approved the vaccine, including neighbours Singapore, Indonesia, and Thailand.
However, its efficacy across all four types of dengue virus and side effects among individuals of different seropositivity have been questioned by medical experts worldwide.
