By CHARINA CLARISSE L. ECHALUCE
The Food and Drug Administration (FDA) has suspended the sale, distribution, and marketing of anti-dengue vaccine Dengvaxia, officials announced yesterday.
“On 29 November 2017, Sanofi Pasteur, Inc. (Sanofi) released an advisory providing updated information on the Dengue Tetravalent Vaccine (Live, Attenuated), the drug locally registered as Dengvaxia. The advisory contained information on the completion of a post-clinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization,” according to the FDA advisory signed by Director General Nela Charade Puno on December 4,” .
“In order to protect the general public, the Food and Drug Administration immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA. Sanofi was further directed to conduct an information dissemination campaign through ‘Advisories, Dear Doctor Letters and Patient’ fora,” it added.
Dengvaxia, the first dengue vaccine to be licensed after being approved in Mexico in December 2015, was used in the Department of Health’s (DoH’s) dengue vaccination initiative that was launched in three highly endemic regions (Regions 3, 4-A, and National Capital Region) with over 733,000 individuals receiving at least one dose of the vaccine.
Last Friday, Health Secretary Francisco Duque III put on hold the mass dengue immunization program, following the new analysis on the Dengvaxia.
“In the light of this new analysis, the DoH will place the dengue vaccination program on hold while review and consultation is ongoing with experts, key stakeholders, and the WHO,” Duque said.
“The DoH is highly committed in strengthening and intensifying its ongoing surveillance and monitoring to evaluate the program and ensure safety,” he added.
He said there will be “mandatory history taking on the immunization of vaccinees” and “mandatory reporting of hospital cases of vaccinees regardless of the symptoms.”
