FDA: Duterte's Sinopharm vaccine under limited use permit

The Philippines' Food and Drug Administration (FDA) said on Tuesday, May 4, that Sinopharm's COVID-19 vaccine administered to President Rodrigo Duterte is covered by the compassionate use permit (CSP) that the agency issued last February.

In an interview with GMA's Dobol B TV, FDA Director General Eric Domingo said that the limited use permit was granted to the Presidential Security Group (PSG) before the vaccines arrived in the country. He did not specify though when the Sinopharm shots arrived in the country.

"Ito ‘yung hiningi ng PSG dati bago pa dumating ang mga bakuna dito sa Pilipinas. Mayroon silang donation from China at hiningan ito ng special permit para nga maprotektahan ang Presidente at mukhang 'yun din po ang ginamit sa ating pangulo kagabi," Domingo said.

(This is the permit that the PSG applied for before the vaccines arrived here in the country. They received a donation from China and they applied for a special permit to protect the President and it seems this is the same one that was used on the President last night.)

A CSP allows for the limited use of investigational drugs or unregistered drugs.

On Monday night, Duterte received the COVID-19 vaccine developed by Chinese-run pharmaceutical firm Sinopharm. The President had said on previous occasions that he preferred it over other vaccines.

Malacañang did not say which of the two Sinopharm vaccines the President received but the most well known is BBIBP-CorV. This inactivated virus type of vaccine was said to be 79% effective against COVID-19, based on an analysis released by Sinopharm.

Meanwhile, the United Arab Emirates Phase III trials showed BBIBP-CorV had an 86% efficacy.

The FDA has yet to issue an emergency use authorization (EUA) for the Sinopharm vaccine. What was issued n February was a CSP covering 10,000 Sinopharm vaccine doses purchased by the PSG.

Domingo said that the CSP will also cover the wives and partners of PSG members. He also said that at least two firms have expressed their intent to apply for EUA for the Sinopharm vaccine. – Rappler.com

Bonz Magsambol

Bonz Magsambol is a multimedia reporter for Rappler, covering health, education, and social welfare. He first joined Rappler as a social media producer in 2016.