DOH says suspension on Dengvaxia likely to remain

Published December 11, 2018, 4:50 PM

by AJ Siytangco

By Analou De Vera

The Department of Health (DOH) said that the suspension on the product registration of the controversial Dengvaxia vaccine, which is set to expire on December 29, will not likely be lifted.

(MANILA BULLETIN)
(MANILA BULLETIN)

“As of now, the one-year suspension of the Dengvaxia CPR (Certificate of Product Registration) is not yet lifted. And I do not see it being lifted anytime soon,” said Health Undersecretary Rolando Enrique Domingo.

The Food and Drug Administration (FDA) suspended the vaccine’s CPR last year after its manufacturer, Sanofi Pasteur, reportedly failed to comply with the agency’s post-marketing requirements.

The agency, in its Advisory No. 2017-318, said that it “directed Sanofi to suspend the sale/distribution/marketing/ of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.”

This came after the French pharmaceutical giant made an announcement that its vaccine may pose health risk to people who have not been previously infected with Dengue.

“We still have pending issues with the vaccine and at this time we do not see it as registered and allowed for marketing in the Philippines especially with pending regulatory issues and cases in court,” said Domingo.

The health official, meanwhile, said that the controversial vaccine will not likely be making a “comeback” in the country.

“Even if its suspension is lifted, I doubt if people will still let themselves be vaccinated with Dengvaxia,” said Domingo.

 
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