FDA to DOH: Distribute COVID-19 vaccines only after clearance for use

FILE PHOTO: Vials labeled “AstraZeneca, Pfizer – Biontech, Johnson&Johnson, Sputnik V coronavirus disease (COVID-19) vaccine” are seen in this illustration picture taken May 2, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

MANILA, Philippines — The Food and Drug Administration (FDA) has reminded the Department of Health (DOH) to only distribute COVID-19 vaccines to local government units (LGUs) once the doses secure a certificate of analysis and have been cleared for use.

FDA Director-General Eric Domingo issued the statement after several LGUs suspended their Sinovac vaccination schedule pending the release of a certificate of analysis.

“Ang bakuna po, talagang hindi pupuwede gamitin hangga’t hindi lumalabas ang certificate of analysis to show na pasado siya. Kasi po, hindi naman natin mababawi ang bakuna pag na-iniksyon na,” Domingo said Wednesday in an interview over Teleradyo.

(Vaccines cannot be used without the certificate of analysis showing they passed all tests. Because we cannot withdraw it after it was injected.)

“Kaya pinaalalahanan din po amin ang DOH [Department of Health], hindi po dapat dinidistribute muna ang bakuna nang hindi pa pasado sa certificate of analysis. Kailangan po, pag dinistribute siya, ay ready for use na siya,” he added.

(That’s we reminded the DOH that vaccines should not be distributed when these have yet to secure a certificate of analysis. It should be distributed when it’s ready for use.)

Domingo explained that the certificate of analysis is proof of the vaccines’ quality and safety for use.

“Ang ginawa po kasi ata e parang dineliver na, naka-preposition na. Para pagdating ng resulta ng certificate of analysis, e magamit na agad. Kaya lang po, mas mabuti po kasi dinedeliver pag kumpleto na lahat ng tests ng bakuna,” Domingo said.

(What was done was to deliver the jabs so that it is already prepositioned. This way, the vaccines can be used immediately after the certificate of analysis is released. However, it is better to deliver the jabs once the tests have been completed.)

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