The Department of Health (DOH) has rejected the request of Sanofi Pasteur to overturn the decision of the Food and Drug Administration (FDA) to ban the use of Dengvaxia vaccine in the Philippines.

With this, the DOH approved the ruling of the FDA to permanently revoke the certificate of product registration of Dengvaxia for Sanofi’s failure to submit the necessary post-approval requirements.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” DOH Secretary Francisco Duque III said in a statement.

Although Sanofi was able to submit the first two versions of its risk management plans (RMP), the pharmaceutical company failed to submit the third and final version of the plan.

The DOH said, however, that Sanofi may apply for a new certificate of product registration (CPR) for Dengvaxia but this must be in accordance with the FDA regulations.

“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the statement added.

Meanwhile, the department has assured that it continues to address the increasing cases of dengue in the country. /mbmf

French Pharmaceutical firm, Sanofi Pasteur expressed optimism that the Dengvaxia vaccine will be restored in the Philippine market.

In a statement, Sanofi Pasteur Philippines General Manager Jean Antoine Zinsou said they are open for a discussion with the Food and Drug Administration (FDA) and the Department of Health (DOH).

He also clarified that Dengvaxia is safe and effective to use.

According to Zinsou, the said vaccine was only banned in the Philippines because of incomplete documents or due to “administrative consideration.”

“We definitely need to settle this issue. One way to do it is to discuss with FDA and see what is needed to have this revocation lifted,” he said.

Zinsou also said Dengvaxia is registered in 20 countries across the globe and is acknowledged by the United States Food Drug Administration and the World Health Organization (WHO).

Meanwhile, Sanofi agrees with the DOH that Dengvaxia is not a solution to the Dengue epidemic in the country.

READ: Dengvaxia won’t bring dengue cases down – DOH

“The vaccines that we are mentioning is not a solution or a silver bullet for the ongoing outbreak. We are open to any discussion with the health authorities to see what is needed, what do they need for the future,” Zinsou said.

In February this year, the FDA revoked the certificate of product registration of Dengvaxia.

Sanofi already filed an appeal two weeks ago and the DOH will release their decision on the issue on August 19.—AAC (with reports from Aiko Miguel)

The Department of Health (DOH) has belied the accusation made by families of Dengvaxia vaccinees that they received a P50,000 bribe from the department.

Health Secretary Francisco Duque III clarified that the P50,000 financial assistance did not come from the DOH.

“Iyang ayuda na iyan galing iyan sa Office of the President so hindi iyan galing sa DOH. Ito lamang ay dahil sa malasakit ng Pangulong Duterte para sa mga magulang na namatayan at gumastos para sa kanilang wake at paglibing at mga iba pang mga gastusin (That assistance came from the Office of the President, not the DOH. It was borne out of President Duterte’s concern for the parents of alleged Dengvaxia victims who had to pay for the wake, burial and other expenses),” he said.

This was after reports that several families of the Dengvaxia vaccinees are accusing the DOH of bribery after the department has offered them P50,000 financial assistance.

Several of them said they were asked to submit original documents and other information. They think these would be used as evidence in order to bring back the use of Dengvaxia amid the rise of dengue cases.—AAC (with reports from Aiko Miguel)