The Health Department affirmed the permanent ban imposed on the controversial Dengue vaccine- Dengvaxia.
This means that the DOH has permanently revoked the certificates of product registration (CPRs) of Dengvaxia because its manufacturer Sanofi Pasteur has failed to submit post-approval requirements.
The Health Department however clarified that the Sanofi can still apply with new CPR as long as they comply with all the requirements
Health Secretary Francisco Duque said that the revocation was not because of the Dengue vaccine’s effectivity but it is purely technical.
The DOH says that most of the concerns include Sanofi’s complete disregard of Food and Drug Administration’s (FDA) regulations, which were precisely put in place by law to ensure safety.
The Food and Drug Administration revoked Dengvaxia’s certificate last February.
Doctors and patients group called on the return of the Dengvaxia to prevent future Dengue epidemic.
