DOH denies Sanofi appeal for Dengvaxia permits

The Department of Health (DOH) has denied the appeal of pharmaceutical company Sanofi Pasteur, Inc. to give its controversial anti-dengue vaccine Dengvaxia the necessary permits.

The DOH in effect upheld the revocation of the permits by the Food and Drug Administration, the agency announced on Thursday.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Health Secretary Francisco T. Duque III said in a statement.

The DOH reached the decision on August 19.

FDA earlier revoked Dengvaxia’s Certificates of Produce Registration (CPRs) due to the continued failure of manufacturer Sanofi to submit post-approval requirements.

DOH said Sanofi, as a holder of the CPRs for Dengvaxia and Dengvaxia MD, should comply with the post-marketing commitments including the submission of Risk Management Plans (RMP).

Dengvaxia being an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety, DOH added.

According to the health agency, Sanofi has failed to submit the third version of RMP and has belatedly submitted the fourth version, which violates post-marketing commitments and FDA’s rules and regulations.

“The Department of Health is committed to strong and strict implementation of our health laws and regulations,” Duque said.

“We know how critical this is to our efforts to rebuild public trust and confidence in our public health programs and in vaccines that have long been proven effective,” he added.

DOH clarified that ‘the efficacy of the Dengvaxia itself is not in issue in this case.’

Allegations were raised against Dengvaxia that it had caused the death of several children who were injected with the dengue vaccine.

Amid the national dengue epidemic, DOH said Sanofi has been notified that it can still apply for new CPRs, faithfully complying with all relevant laws, rules, and regulations.

DOH said it maintains that the registration of Dengvaxia depends on FDA’s approval, while the agency is now focusing on response to dengue. —NB, GMA News