Deal with AstraZeneca may be canceled if COVID-19 vaccine doesn’t pass FDA review - Duque

Kristine Sabillo, ABS-CBN News

Posted at Nov 30 2020 07:12 PM

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed AstraZeneca logo in this illustration taken Oct. 31, 2020. Dado Ruvic, Reuters/File

MANILA — Health Secretary Francisco Duque III on Monday said the Philippines can still void its supply deal with AstraZeneca if the Food and Drug Administration (FDA) does not approve its COVID-19 vaccine for use in the country.

“Nakapaloob naman sa agreement (na) kailangan dumaan sa mahigpit na pagsusuri,” Duque said during the Laging Handa briefing. “Sumang-ayon naman ang AstraZeneca.

(Included in the agreement is the provision that it must undergo strict review. AstraZeneca agreed with this.)

Last week, Filipino companies signed a deal with AstraZeneca for 2.6 million doses of its vaccine, which is expected to cover more than 1 million Filipinos. But while the company claims that it has an average efficacy of 70%, questions were raised about the number and ages of participants included in the study.

Duque said the vaccine will be scrutinized by the vaccine experts panel before being reviewed by the FDA.

He pointed out that there will also be a clinical trial in the Philippines so that would be added assurance that the vaccine would be safe for Filipinos.

The application of the company for a clinical trial is currently under review with the ethics review board. It will then go through final review by the FDA.

“Mahihirapan pong makalusot 'yan kung merong makikita sila na hindi magandang resulta at pwedeng makaapekto sa pagiging ligtas, dekalidad at epektibo ng bakuna,” Duque said.

(It will be hard for them to pass the evaluation if the result won’t be good or would have an effect on the vaccine’s safety, quality and efficacy.)

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