KUALA LUMPUR, 3 Dec 2017:
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 is 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 yesterday in response 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.
There was a 14.7% spike in dengue cases in Negeri Sembilan between January and Nov 25, when 2,948 cases were recorded as compared to 2,571 cases for the same period last year.
State health director Dr Zainudin Mohd Ali said however, the number of dengue deaths had dropped to 11 compared to 24 deaths recorded in the same period last year.
“Over the past four months, the number of dengue cases recorded in the state dropped to an average of more than 20 cases a week, compared to the previously recorded average of 30 cases.
“Since October, no more areas were identified as dengue hotspots.”
Dr Zainudin said Negeri Sembilan ranked fifth with the highest number of dengue cases in the country as of Nov 25 – behind Selangor, the Federal Territory of Putrajaya, Johor and Perak.
“We expect a spike in dengue cases starting this month until January next year, due to the rainy season which promotes mosquito breeding.”
– Bernama