FDA: AstraZeneca, with data complete, cancels clinical-trial application in PH

Raphael Bosano, ABS-CBN News

Posted at Dec 11 2020 06:21 PM

FDA: AstraZeneca, with data complete, cancels clinical-trial application in PH 1
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MANILA — UK-based pharmaceutical company AstraZeneca has withdrawn its application to conduct clinical trials in the country, Food and Drug Administration Director-General Dr. Eric Domingo confirmed on Friday. 

In a phone interview, Domingo said AstraZeneca has deemed its data complete to support its efficacy.

“Nag-notify sila sa FDA na winithdraw nila yung kanilang application dahil ang kanilang binigay na dahilan ay kumpleto na ang kanilang data para maipakita ang efficacy ng kanilang vaccine and to support yung kanilang magiging application for EUA,” he said. 

This means that the initially planned clinical trial following a vaccine expert panel and ethics board-approved protocol will most likely no longer push through. The FDA, however, is still open to accepting applications should AstraZeneca still decide to conduct another trial. 

But should the drugmaker decide to conduct another trial using a different protocol, they would have to go back to the first step of the regulatory process. 


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“Kung magkaroon ng bagong protocol. For example, magiging iba na yung design ng kanilang study, halimbawa babaguhin yung dosage or yung study population ay iba na sa original protocol na sinumbit nila then they would have to go to step 1 again,” Domingo said. 

The withdrawal of AstraZeneca has left the FDA with 2 applications. The agency is also expecting another application to be filed by Johnson and Johnson’s Janssen.

“Ang naka-lodge sa atin na applications yung sa Sinovac at Clover. Hinihintay natin magsubmit yung Janssen kasi mukhang nakalusot na rin sila sa vaccine expert panel pero hindi pa sila officially nagsusubmit ng application sa FDA,” he said. 

Domingo said even if AstraZeneca hasn’t conducted a clinical trial in the country, it can still file an application. 

“Kailangan lang maipakita nila kung meron silang subset ng pasyente na similar sa atin na mga Asians or racially very similar to Filipinos. Kung mapakita na maganda rin ang safety at efficacy pwede naman mag apply sa atin pa rin,” Domingo said.