Sanofi appeals Dengvaxia registration as dengue cases spike

Jamaine Punzalan, ABS-CBN News

Posted at Aug 01 2019 11:41 AM | Updated as of Aug 01 2019 11:57 AM

MANILA - French drug maker Sanofi is appealing the revocation of its dengue vaccine's registration as outbreaks of the mosquito-borne disease hit parts of the country, a health official said Thursday.

The Food and Drug Administration permanently revoked the certificate of product registration of Dengvaxia in February, about a year after Sanofi admitted that the drug can cause more severe symptoms among those who have not had dengue.

"Nitong last week, nagpadala ng appeal ang Sanofi sa Office of the Secretary to appeal iyung kanilang certificate of product registration. Hindi pa po ito naaksyunan at siguro po ini-evaluate po lamang po ng office ng secretary," said Health Undersecretary Eric Domingo.

(Last week, Sanofi sent an appeal to the Office of the Secretary to appeal their certificate of product registration. There is no action on this yet and perhaps is still being evaluated by the office of the Secretary.)

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For now, Dengvaxia "is not available" and "cannot be used in the Philippines," he said.

Authorities disagree publicly over whether Dengvaxia, the first of its kind, could have contributed to the deaths of several children.

Reports of alleged deaths due to Dengvaxia have spawned a vaccination scare that led to a drop in immunization coverage in the country to 40 percent last year, from an average 70 percent in recent years.

The government recorded 115,986 dengue cases nationwide from Jan. 1 to July 6, about an 85 percent increase from the 57,564 reported during the same period last year, Health Secretary Francisco Duque III earlier said.

The government should consider making Dengvaxia available to the public anew if there are enough findings to support its efficacy and safety, Presidential Spokesman Salvador Panelo said Wednesday.