KUALA LUMPUR, Dec 3 — The Ministry of Health confirmed that the world’s first dengue vaccine, Dengvaxia, is not distributed or used by any health facility either in the public or private sector in this country.
Health director-general Datuk Dr Noor Hisham Abdullah said this was because the product was not approved as part of the ministry’s national immunisation programme.
“Until now, no one is using the Dengvaxia in the country,” he said in a statement, here yesterday.
It was in respond to reports on international and local print and electronic media on Dengvaxia and its suspension by the Philippines following a statement posted by the producer, Sanofi Pasteur on its official website.
Dr Noor Hisham said six years of studying clinical data found that Dengvaxia provides protective benefit against dengue fever in those who had prior infection, but the dengue vaccine could lead to more severe dengue symptoms for people who have not been infected. —
Hence, the Malaysian Drug Control Authority (MDCA) only granted a two-year conditional registration approval from Nov 25 last year to the company producing the vaccine, Sanofi Pasteur.
“Approval is only given for the Dengvaxia to be used in Phase IV clinical trials aimed at getting more information on the safety of the vaccine. In addition, the producer has to meet seven conditions before the product can be brought into Malaysia.”
The ministry through the MDCA always prioritises consumer safety and caution in approving any product registration as well as having the product evaluated by the National Pharmacy Regulatory Division to ensure that product meets the standards and guidelines set.
The public is urged to ensure that products used are registered and have a hologram sticker and labelled with a valid registration number. Checking the registration status of a product can be done by visiting the website at http://npra.moh.gov.my. — Bernama