FDA: No changes yet in AstraZeneca EUA


There will be no changes in the emergency use authorization (EUA) granted by the Philippine Food and Drug Administration (FDA) to the COVID-19 vaccine developed by AstraZeneca.

The assurance came from the FDA following the reported suspension of the vaccine’s use in South Africa due to efficacy issues against a new variant that appeared in the country.

FDA Director-General Eric Domingo assured in the Laging Handa Public Briefing that the EUA will remain without any changes because the South African variant has not yet been in the Philippines.

“Sumulat din sa atin ang WHO kaninang umaga, sinasabi na wala silang nakikitang pagbabago sa mga indications nitong Astrazeneca vaccines (The WHO also wrote to us this morning, saying that it has not yet seen changes in the indications of AstraZeneca vaccines),” Domingo said.

“But they will keep everybody updated kung nagbabawas nga ng kanyang efficacy sa circulating na virus at this time (But they will keep everybody updated if its efficacy declined for the circulating virus at this time),” Domingo added.

AstraZeneca is the second vaccine developed to receive an emergency use approval in the country after Pfizer-BioNTech. Data on the efficacy of the vaccines against new variants have yet to be relayed.
The FDA is currently evaluating EUA applications of Russian vaccine developer Gamaleya for its Sputnik V and China’s Sinovac. The Bharat Biotech application has yet to be evaluated pending results of its third phase trials. – Report from Mark Fetalco

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