The Director General of Health, Noor Hisham Abdullah, says that the first vaccine against Dengue fever in the world, Dengvaxia, must meet several established conditions before the product can be introduced in the country.
KUALA LUMPUR: The health ministry has confirmed that the world's first Dengue vaccine, Dengvaxia, is not distributed or used in any health facility, in the public sector or in the public sector. private, in this country.
The Director General of Health, Noor Hisham Abdullah, said that this was because the product was not approved as part of the ministry's national immunization program.
"So far, no one is using Dengvaxia in the country," he said in a statement yesterday.
It was in response to the reports on international and local organizations. print and electronic media on Dengvaxia and its suspension by the Philippines after a statement published by the producer, Sanofi Pasteur, on its official website.
Noor Hisham said that six years of clinical data study found that Dengvaxia provides a protective benefit against dengue in those who had a previous infection, but the vaccine against dengue could lead to more severe symptoms of dengue for people who They have not been infected.
Therefore, the Malaysian Drug Control Authority (MDCA) only one conditional registration approval of 2 years from November 25 of last year to the company that produces the vaccine.
"The approval is only granted for the use of Dengvaxia in phase IV clinical trials to obtain more information on the safety of the vaccine, and the producer must meet seven conditions before being able to take the product to Malaysia."
The Ministry, through the MDCA, always prioritizes the safety and precaution of the consumer when approving any product registration, in addition to the product being evaluated by the National Pharmacy Regulation Division to guarantee that the product complies with the established standards and guidelines.
The public is urged to ensure that the products used are registered and have a hologram label and are labeled with a valid registration number.
Verification of registration The status of a product can be made by visiting the website at https://npra.moh.gov.my .
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