Urging the health ministry to be extra vigilant in studying research documents before approving them, the National Association of Patriots (PPK) said for dengue vaccine Dengvaxia, harm outweighed the benefits.
“The health of our people ranks supreme and officials on the government payroll owe it to the people to execute their responsibilities well,” PPK PR director Dr Wong Ang Peng said in a statement.
The safety fears in question involve possible increased risk to people who were not exposed to the dengue virus prior to vaccination.
In a statement on Nov 27, Dengvaxia producer Sanofi-Pasteur said the vaccine provides persistent benefit against dengue fever in those who had prior infection.
However, for those who had not previously been infected with dengue, more severe cases could occur following vaccination upon a subsequent dengue infection.
Wong, who specialises in naturopathy and has done research on heart failure, said there were a total of four dengue serotypes.
Recovery from infection by one virus provides lifelong immunity against that particular serotype.
Dengvaxia was intended to provide protection against DENV-3, which is the most common strain of dengue.
Wong said it was dishonest of the pharmaceutical giant to imply that the vaccine gave protection against dengue in general.
He said Sanofi had also acknowledged that for those who are seronegative, or had never been infected by any of the four serotypes, Dengvaxia could lead to a more severe condition than if the person had never received the vaccine.
“As early as September 2016, there were reports of more hospitalisations for severe adverse events due to the administration of Dengvaxia.
“Despite alarm bells, our health ministry in November 2016 proceeded to grant a two-year conditional registration approval for Phase IV clinical trials,” he added.
On Sunday, Health director-general Noor Hisham Abdullah said Dengvaxia was not distributed or used by any health facility in Malaysia, either in the public or private sector.
He added that the product was not approved as part of the ministry’s national immunisation programme.
Trouble mounts for Sanofi dengue vaccine over safety concerns