COVID vaccine may be ready by Q1 2021 – FDA chief

Food and Drug Administration (FDA) director-general Eric Domingo said Thursday a COVID-19 vaccine may be ready for distribution in the Philippines by March 2021.

Doming projected the release date a day after the United Kingdom allowed the Pfizer-BioNTech COVID-19 vaccine for use.

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The FDA chief added there is also information that the US FDA would issue emergency use authorization for Pfizer and Moderna’s COVID-19 vaccine within two weeks.

“Kapag nag-apply po sila dito sa atin maaring by first few weeks of January mayroon na rin po tayong maibigay na emergency use authorization. Baka mapaaga nang kaunti, baka magkaroon ng chance na mga March ay magkaroon na ng bakuna sa Pilipinas,” he said.

Domingo also said the COVID-19 vaccines could be available as early as January next year.

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“Totoo po ‘yan. Talagang magiging depende na lang sa production, kung mayroong mailalaan na supply para sa Pilipinas at maide-deliver agad dito sa atin para ma-distribute natin,” he said.

COVID vaccine may be ready by Q1 2021 – FDA chief

Domingo said vaccines that already secured emergency use authorization (EUA) from their country would likely be the first ones to get the same here.

“Ang mauuna siguro ‘yung mga mayroon nang EUA [sa ibang bansa] katulad ng Pfizer, saka itong Sinovac, Sinopharm, Moderna, AstraZeneca. Ito po ay mga nag-apply na,” he said. “Kapag nag-apply na po sila sa atin, within 21-28 days ay mabibigayan po natin ng desisyon kung approved or disapproved ang kanilang application.”

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On Wednesday, President Rodrigo Duterte, through Executive Order 121, allowed the FDA to issue EUA for COVID-19 drugs and vaccines.

The EO said EUA may be issued if the following terms are met:

  • Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
  • The known and potential benefits of the drug or vaccine when used to diagnose, prevent, or treat COVID-19 outweigh the known and potential risks of the drug or vaccine if any; and
  • There is no adequate, approved, and available alternative to the drug or vaccine to diagnose, prevent, or treat COVID-19.