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DOH Revokes Dengvaxia’s Certificate Of Product Registration

The Department of Health maintained its position on canceling Dengvaxia’s Certificate of Product Registration (CPR) due to Sanofi Pasteur’s violation of the Food and Drug Administration (FDA) regulations.

Health Secretary Francisco Duque III said Sanofi Pasteur was not able to submit the third and fourth versions of its risk management plans, including a report on the steps taken by the pharmaceutical company following the Dengvaxia scare in 2017.

Cancellation and revocation

DOH canceled Dengvaxia’s CPR in 2017 after Sanofi Pasteur issued a statement that the vaccine poses risks to those patients without prior history of dengue. In 2018, Dengvaxia’s CPR was finally revoked. Since then, Dengvaxia was no longer available in the market.

DOH Revokes Dengvaxia's Certificate Of Product Registration 1

To recall, there were about 830,000 individuals from Central Luzon, Calabarzon and Metro Manila who received Dengvaxia vaccines through the government’s mass immunization program. DOH was headed by then-Secretary Janette Garin.

DOH Revokes Dengvaxia's Certificate Of Product Registration 2
Manila Bulletin

Dengvaxia scare and deaths

Numerous deaths were linked with Dengvaxia, but no official findings were released yet. This also dropped the national vaccine coverage as a result of the Dengvaxia scare. Additionally, lawsuits were filed and investigations have been conducted against Dengvaxia. 

Duque said Sanofi Pasteur may reapply for CPR renewal if recommended by the Dengue Vaccine National Expert. Or, the pharmaceutical company may appeal to the President to reverse the revocation of Dengvaxia’s permit.

Garin wants probe on Duque

Meanwhile, the former Health secretary wanted to have the present Health chief to be investigated regarding the revocation of the vaccine’s CPR.

Nakakalungkot po na masyadong nagiging politiko ang ating Secretary of Health at hindi niya po sinusunod ang nararapat para sa kalusugan ng lahat,” said Garin, now Iloilo’s 1st District representative.

Sanofi Pasteur also denied committing a violation against FDA regulations. The French company said it will exhaust all legal remedies to bring back Dengvaxia in the Philippines.

The DOH acknowledged that “the safety of Dengvaxia is not on trial.”

Source: CNN Philippines

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