Dengvaxia ban stays, says DOH

Citing Sanofi Pasteur’s  continued “failure to submit postapproval requirements,” the Department of Health (DOH) denied the French pharmaceutical company’s appeal to have the ban lifted on the country’s use of the dengue vaccine Dengvaxia.

In a decision dated Aug. 19, the DOH backed the earlier decision of the Food and Drug Administration (FDA) to revoke permanently the vaccine’s certificates of product registration (CPRs), but said the company may reapply for new CPRs amid a nationwide dengue epidemic, as long as it complied with all relevant laws, rules and regulations.

“The decision is very clear, without prejudice to the application for a new CPR by Sanofi… It will probably take anywhere from three to six months to process a CPR in case this gets applied for,” Health Secretary Francisco Duque III said at a press briefing on  Thursday afternoon.

In February, the FDA permanently revoked Dengvaxia’s CPR following Sanofi’s failure to submit documentary evidence showing the vaccine was safe and effective for public use.

The decision came over a year after the pharmaceutical giant disclosed in November 2017 that the vaccine may cause severe dengue among those who have not been previously exposed to the mosquito-borne disease.

About three weeks ago, Sanofi appealed the FDA revocation to the DOH.

In a statement, Duque said the DOH’s decision to deny the appeal had nothing to do with the efficacy of Dengvaxia, but “concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety.”

In a statement, Sanofi Pasteur said that while it “respectfully disagree(s) with the cited violations that led to the decision denying our appeal on procedure, we are grateful to the DOH for recognizing that the ‘safety of Dengvaxia is not on trial’ and for emphasizing ‘the dire need to have [a dengue vaccine] introduced or—in the case of Dengvaxia—reintroduced in the market.’”

According to Sanofi, it will thoroughly study all possible remedies under Philippine laws and regulations while keeping in mind the best interest of Filipinos.

According to the DOH, Sanofi only submitted first and second versions of its risk management plans (RMPs), which are postmarketing requirements that ensure public safety.

As a holder of the CPRs for Dengvaxia and Dengvaxia MD, Sanofi is bound by postmarketing commitments, including the submission of RMPs, the DOH said.

It added that Sanofi had failed to submit its third RMP and was late in submitting its fourth RMP, a violation of its postmarketing commitments and pertinent FDA rules and regulations.