FDA to probe Mon Tulfo's use of 'smuggled' coronavirus vaccine

Jamaine Punzalan, ABS-CBN News

Posted at Feb 24 2021 12:14 PM | Updated as of Feb 24 2021 02:13 PM

Television host, radio broadcaster and Manila Times columnist Ramon Tulfo attends a Senate hearing on Sept. 22, 2020. Joseph Vidal, Senate PRIB/File

MANILA (UPDATE) - The Food and Drug Administration on Wednesday said it would investigate columnist and special envoy to China Mon Tulfo's admission of use of a smuggled COVID-19 vaccine.

Tulfo had said he got hold of unauthorized coronavirus shots by Chinese state firm Sinopharm through a friend "who smuggled it into the country."

He took the illegally procured vaccine with some "Cabinet-level" officials, a senator, and some members of Duterte's security team, the columnist said in an interview with One News on Tuesday. 

FDA Director General Eric Domingo said he would refer this report to the regulatory enforcement unit of his agency for investigation. 

"Kaya nga po iniimbestigahan siya, dahil talaga nga pong hindi naman po maganda na nalalaman natin na may mga ganitong nagpapabakuna na hindi dumadaan sa tamang proseso," he said in a public briefing, when asked if he found the news alarming. 

(We are investigating this because it is not good that we learn that there are vaccinations that do not go through the right process. )
 
Sinopharm has not yet applied for emergency use authorization in the Philippines.

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SANCTION

In response to Tulfo's disclosure, the Department of Health warned the public that the use and distribution of smuggled vaccine is illegal.

"As to those people who are using vaccines without EUA (emergency use authorization) and also suppliers supplying vaccines without EUA, ito po ay ilegal at maaari po kayong ma-sanction at mabigyan ng (this is illegal and you can be sanctioned and given) penalties because of this," Health Undersecretary Maria Rosario Vergeire said in a press briefing.

She said Tulfo would have to apply for necessary permits if he would be designated by the Chinese company as its local distributor in the Philippines.

"Everything has to go under this process of regulation at titignan natin kung siya po ba talaga ay mabibigyan ng official na designation na siya po ang (and we'll see if he will be given official designation as the) authorized distributor of this specific vaccine to the country," Vergeire said.

Under Republic Act 9711 or the Food and Drug Administration (FDA) Act of 2009, manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded is prohibited.

Violators may face jail term of between a year to 10 years or fine up to P500,000 or both.

If the offender is a manufacturer, importer or distributor of any unauthorized health product, the penalties could be imprisonment for up to 10 years and P5 million in fine.

Republic Act 2382 or The Medical Act of 1959 also imposes a fine of up to P10,000 or imprisonment from 1 to 5 years, or by both on those who engage in “illegal practice of medicine.”

Courtesy of DOH

PSG

Duterte in December revealed that some members of his security detail took Sinopharm shots. He later told them to "shut up" if called in Congress to explain their illegal inoculation. 

The FDA and the National Bureau of Investigation are undertaking separate investigations into the matter.

The Presidential Security Group has yet to reply to FDA's inquiry on their unauthorized vaccine use, said Domingo. 

"Iyon pong sa PSG, hanggang ngayon po wala pa pong kasagutan iyong aming tanong. Pati po ang DOH sumulat sa kanila, pero as of now, wala pa po kaming nakuhang impormasyon," he said. 

(The PSG has yet to reply to our query. The Department of Health wrote to them, too. But as of now, we have not yet received any information.)

Earlier this February, the FDA allowed Duterte's security team to import and use 10,000 Sinopharm shots. 

“Nasa priority naman po ang ating kasundaluhan. At matagal na po nating napag-usapan ‘yan na seguridad at kalusugan ng Presidente ang pinangangalagaan,” Palace spokesman Harry Roque had told reporters in an online briefing.

(Soldiers are on the priority list and we have previously discussed that they are taking care of the security and health of the President.) 

— with reports from Davinci Maru, ABS-CBN News