FDA can't assure safety, efficacy of vaccine given to Duterte

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Metro Manila (CNN Philippines, May 6) — The Food and Drug Administration cannot assure the safety and efficacy of vaccines approved for compassionate use like the one that President Rodrigo Duterte got early this week.

"Hindi namin magagarantiyahan po kasi ang bakuna na CSP (compassionate special permit) kasi hindi po ito in-examine ng ating experts at hindi po ito binigyan ng authorization ng FDA," Dirctor General Eric Domingo explained in a briefing when asked about the unapproved vaccine given to Duterte.

[Translation: We cannot guarantee [the safety and efficacy] of a vaccine covered by a CSP because this is neither examined by experts nor authorized by the FDA.]

The President on Wednesday apologized to the public for choosing to be inoculated with Sinopharm vaccine.

He also asked the Chinese Embassy to withdraw the Sinopharm doses that China donated to the Philippines.

His remarks came after his immunization on Monday drew wide criticisms because he received a shot that was not approved for emergency use by the FDA.

Malacanang said it was the President's physician who chose the Chinese-made vaccine for him.

The Palace earlier said the shot administered to Duterte was among those "covered by the compassionate use permit issued to the PSG (Presidential Security Group) hospital by the FDA."