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Sotto wants DOH to focus on Dengvaxia’s FDA approval under Garin: Sino na maniniwala?

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Senate Majority Leader Vicente Sotto III is urging Department of Health (DOH) Sec. Francisco Duque III to look into the decision of the Food and Drug Administration (FDA) to approve the “marketing” of controversial Dengvaxia dengue vaccine two years ago.

“Dapat mag-imbestiga ang DOH mismo. So within their ranks, we will ask Duque to do that. He is the new secretary dapat imbestigahan nya ang FDA na yan, how come it approved Dengvaxia,” he said.

Sotto noted that when the FDA approved of Dengvaxia vaccine, there has been no studies made on its side effects.

The FDA was under then Health Sec. Janette Garin as she was then the agency’s office-in-charge (OIC).

Sen. Richard Gordon, who initiated the probe on the dengue vaccine in the Senate, had earlier claimed that the FDA approval came in Dec. 22, six days after the release of funds or the special allotment release order (SARO) was issued by the Department of Budget and Management (DBM). This was 11 days after the justification for the procurement of the vaccine was made.

Sotto said this has undermined the credibility of FDA in ascertaining medicinal benefits and side effects of certain drugs considering that it has made such transgressions previously, such as for birth control drugs.

“So paano na kami ngayon maniniwala?” he asked.

“So ibig sabihin hindi pala katiwa-tiwala ang approval nila, therefore sapul yung mga sinasabi nilang hindi raw abortifacient (na mga medicines). Paano mo ngayon tayo mapapaniwala sa sinasabi nila?” the senator asked.

Sotto said the DOH should initiate probe on this matter, particularly the circumstances that led to the government’s procurement of the P3.5 billion dengue fever vaccine for 700,000 school children in 2015.