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Senators raise concern over FDA’s ‘dangerous’ stance on donated vaccines

/ 07:53 PM January 19, 2021

MANILA, Philippines — Some senators on Tuesday voiced their concerns over the “very dangerous preposition” of the Food and Drug Administration (FDA) that the Philippines may accept and use the Covid-19 vaccines donated by China even without its approval.

“Why should the FDA chief say that it can be used provided it is under the supervision of the Department of Health (DOH)? It is a very dangerous preposition, with all due respect, because then the public confidence in the vaccination process will never be enhanced with such confusing statements,” Senate Minority Leader Franklin Drilon said during the Senate session.

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This issue was raised in plenary after Senator Francis Tolentino delivered a privilege speech touching on FDA’s mandate and how “they are utilizing their functions in an inappropriate manner.”

Tolentino, for his part, appealed to FDA to study the vaccines that would be donated.

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“If the FDA is listening, I appeal, I plead that they study the drugs donated and thereafter and if found appropriate, issue the appropriate EUA to make this all legal,” he said.

Also expressing concern over the recent pronouncement of the FDA chief is Senate President Pro Tempore Ralph Recto.

“Isn’t it that our health workers are the frontliners? Meaning to say ang unang i-inoculate ay ‘yung mga health workers natin? Shouldn’t it be that the most effective and the safest vaccine be given to our health workers?” Recto asked.

(Isn’t it that our health workers are the frontliners? Meaning to say they will be the first to be inoculated. Shouldn’t it be that the most effective and the safest vaccine be given to our health workers?)

“If the FDA has not been able to study any of these vaccines, why should we allow the vaccine to be given to our health workers?” he added.

Senator Risa Hontiveros likewise said she is alarmed by FDA’s position on donated vaccines.

“At this point in time, and I say this heeding the cautionary tone being set by the minority leader and sharing the concern of the Senate President Pro Tempore. On my part, I would even say [I’m] alarmed,” she said.

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“Dahil bilang magulang hindi ko papayagan yung mga anak ko, nung baby sila na, mabakunahan ng walang tatak kumbaga, paga-abpruba ng FDA,” she added.

(As a parent, when my children were babies, I did not allow them to be vaccinated with a drug without the approval of the FDA.)

Meanwhile, Senator Richard Gordon said he was able to talk with Domingo, who said that even if DOH recommends the use of a donated vaccine, the drug would “still need to go through examination and trial before it is admitted.”

“Even if it is admitted, it will only be for that bulk that has been submitted. If they are going to use it en mass they will have to go through another examination process,” Gordon said.

Earlier, FDA director-general Eric Domingo said DOH may accept and use coronavirus vaccines donated by China even if is yet to secure approval from the government regulator.

“Sa Bayanihan Act din po nakalagay iyon na pwede tayong tumanggap ng mga gamot na registered sa home country basta, of course, it will be used under the supervision of the Department of Health,” Domingo said in a briefing earlier Tuesday.

Over the weekend, Chinese State Councilor and Foreign Minister Wang Yi said Beijing will donate 500,000 doses of coronavirus vaccines to the Philippines.

READ: China to donate 500,000 Covid-19 vaccine doses to PH

So far, the only vaccine the FDA allowed usage in the country is the one developed by US pharmaceutical giant Pfizer. The application of China’s Sinovac Biotech is still under review.

Following Domingo’s statement, DOH said it will still wait for the FDA’s authorization before accepting and using the coronavirus vaccines that will be donated by China.

KGA

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