The Department of Health (DOH) is ethically bound to complete the dengue vaccination program regardless of recent actions by pharmaceutical creator and distributor, newly-appointed Assistant Health Secretary Dr. Lyndon Lee Suy said on Tuesday.
“I don't think it's ethically right as well to stop it abruptly. The use of the Dengvaxia is for the three doses. Ethically, you need to complete the three doses as well. There will be more problems if you don't complete the three doses,” Suy said at a press conference at the DOH headquarters.
Whether they will continue the program after the initial run is “another concern” and will be resolved once re-appointed Health Secretary Dr. Francisco Duque is briefed on the issue and a technical working group convenes to discuss it.
It was announced in May that the DOH will halt the dengue vaccination program after completing the third and final round of injections for recepients to await the results of the pilot program and make plans for a second iteration with their findings.
The DOH was questioned for its procurement of Dengvaxia at congressional inquiries due to the amount invested in its procurement and its initial target demographic of a million children, an unusual number for pilot programs.
More recently, Dengvaxia manufacturer Sanofi Pasteur Inc. and drug and beauty products chain Watsons Personal Care Philippines were penalized by the Food and Drug Administration (FDA) for illegally promoting and advertising the dengue vaccine, Dengvaxia.
According to a statement by the FDA in October, both companies were slapped with a P5,000.00 fine for violating Republic Act 9711 or the Food and Drug Act of 2009 and Administrative Order No. 65.
Section 2.3 of AO 65 provides that "No pharmaceutical product classified by BFAD as prescription or ethical drug shall be advertised or promoted in any form of mass media except through medical journal, publications and/or literature solely intended for medical and allied professions."
Dengvaxia by Sanofi Pasteur is classified by the FDA as a prescription product.
Sanofi and Watsons were also warned that their establishments and License to Operate/Certificate of Product Registration may be revoked with future violations of FDA-implemented laws, rules and regulations.
"We are warning local and multinational companies that no one is exempt from the law and they should all comply, or risk having their LTOs and the Certificate of Product Registrations of their medicine products cancelled and revoked," FDA Director General Nela Charade Puno said.
FDA's Center for Drug Regulation and Research discovered the advertisements on dengue vaccination on TV and in malls in 2016.
Neither companies have issued statements regarding the fine since it was announced in October.
Watsons previously complied with an FDA order to stop advertising, promoting and conducting immunization activities in its drugstore chain. —NB, GMA News