Kin of children who allegedly died after being injected with Dengvaxia vaccine on Thursday welcomed the permanent revocation of the certificate of registration of the anti-dengue vaccine.
In an interview, Sumachen Dominguez, Samahan ng mga Magulang ng mga Anak ay Biktima ng Dengvaxia president, thanked the Office of the President for the denial of Sanofi Pasteur Inc.’s plea not to revoke the Food and Drug Administration’s product registration of Dengue Tetravalent vaccine, popularly known as Dengvaxia.
“We are too much elated with the decision of Malacañang affirming the FDA order against Sanofi,” she told the Manila Standard.
“The latest decision of the Palace has already reached us. This is only a validation of our complaint against Sanofi and the other accused [in the multiple counts of reckless imprudence resulting in homicide], aside from their recent indictment by the Department of Justice,” she said.
In a two-page Feb. 19 decision that was released just last Feb. 26, Executive Secretary Salvador Medialdea said “wherefore, the appeal dated 03 October 2019 filed by Sanofi Pasteur Inc. is hereby DENIED. The decision dated 19 August 2019 of the Department of Health is hereby AFFIRMED. SO ORDERED (capitalization Medialdea’s).”
On Aug. 19, 2019, Sanofi filed an appeal to reverse the Dec. 21, 2018 decision and Feb. 15, 2019 resolution of DOH through FDA “permanently revoking certificates of product registration of Dengue Tetravalent Vaccine (Live, Altenuated) (Dengvaxia-MD) and Dengue Tetravalent Vaccine (Live, Altenuated) (Dengvaxia) under CPR Nos. BR-1128 and BR-1129.”
DOH under then Health Secretary Janette Garin, now Iloilo representative, implemented a school-based mass Dengvaxia vaccination in public schools that started in 2016.
At least 830,000 children and policemen received the anti-dengue vaccines.
In November 2017, Sanofi, in a bulletin, admitted that the vaccine may lead to more severe symptoms of dengue for those who have never been infected by the virus prior to the vaccination.
With help from the Public Attorney’s Office, the families of the children whose deaths were linked to Dengvaxia vaccination filed criminal charges against Garin, Philippine Children’s Medical Center executive director Julius Lecciones, current Health Secretary Francisco Duque III, and other active and former health officials before the DOJ.