Dengvaxia ban stays
Highly controversial anti-dengue vaccine Dengvaxia will not have a reprise soon in the local market after the Department of Health (DoH) yesterday denied the appeal of its French manufacturer Sanofi Pasteur to reverse a ban on its sale and use in the Philippines.
In a statement, the DoH said the revocation of the certificate of product registration for
Dengvaxia has been ruled permanent last 19 August due to its “continued failure to submit post-approval requirements.”
“The decision concerns Sanofi’s complete disregard of Food and Drug Administration (FDA) regulations, which were precisely put in place by law to ensure safety,” Health Secretary Francisco Duque III said.
Sanofi still has the option to reapply for a new FDA certificate of registration, according to the DoH, as it said the agency was “focusing” on its response to the national dengue epidemic.
However, it clarified that its denial did not touch on the potency of the medicine.
“The efficacy of Dengvaxia itself is not in issue in this case. The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” according to Duque.
Sanofi has commitments
The Health chief said Sanofi, as a holder of the registration certificates for Dengvaxia and Dengvaxia MD, was bound by post-marketing commitments, including the submission of risk management plans (RMP).
“Given that Dengvaxia is an innovative drug, the importance of complying with postmarketing commitments is critical to public safety,” he added.
The DoH found that, while Sanofi has submitted the first and second versions of the RMP, it has failed to submit the third version and has belatedly submitted the fourth version, in violation of its post-marketing commitments and pertinent FDA rules and regulations.
“The Department of Health is committed to strong and strict implementation of our health laws and regulations. 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,” Duque added.
Experts’ view needed
The DoH rejection came after President Rodrigo Duterte said he was open to the use of Dengvaxia amid a national dengue epidemic.
“Yes, I am open to the use of Dengvaxia again. Many had died, it’s an epidemic,” Duterte recently stated.
The President admitted he remains in a quandary whether or not to lift the ban on the use of Dengvaxia.
“I’d rather go on the side of science. Still I would say that if there is anything there in Western medicine and even in herbal cures of the Orient if it would mean saving people’s lives, I’ll go for it,” he noted.
Duque said amid the nationwide dengue epidemic, Sanofi has been informed that it may reapply for new CPR, “faithfully complying with all relevant laws, rules, and regulations.”
The DoH said it was focusing on its response to the national dengue epidemic.
The Dengue Vaccine National Expert Panel recommends Sanofi’s submission of updated data on pharmacovigilance and post-marketing surveillance.
This should show what the company has done in terms of monitoring and preventing the drug’s adverse effects for the more than 830,000 individuals vaccinated.
DoH maintained that the registration of Dengvaxia is for FDA to act upon and that the department is currently focusing on a response to dengue.
“We assure the public that the Department of Health has been working tirelessly in response to the nationwide dengue epidemic. We are intensifying the 4S strategy through our ‘Sabayang 4 O’Clock Habit’ and ensuring that our health facilities are adequately equipped to serve its patients,” Duque noted.