Dengvaxia ban likely to extend for more than a year – DOH

Dengvaxia ban likely to extend for more than a year – DOH

“Iyong one-year suspension ng Dengvaxia CPR is not yet lifted and I do not see it being lifted anytime soon. We still have a lot of pending issues with the vaccine and at this time we do not see it being registered and allowed for marketing in the Philippines…regulatory issues and cases in Court,” said DOH Spokesperson Usec. Eric Domingo.

It will be recalled that the FDA suspended Sanofi for not submitting its post-marketing authorization requirements which were supposed to prove that the products manufactured by the pharmaceutical company are safe to use.

Sanofi also couldn’t assure the safety of Dengvaxia, according to DOH.

The DOH noted that in November 29, 2017, Sanofi released a statement that Dengvaxia is not advisable to be administered to seronegative recipients —children or adults—who never had dengue infection prior to injection for the reason that their cases are likely to develop into severe dengue.

“It cannot be used without testing for children if they had dengue before. And there are no available testing kits commercially to do that. We don’t see naman any use for the vaccine at this time,” Domingo said.

via Yahoo News Dengvaxia ban likely to extend for more than a year – DOH