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

Popular

P10/L fuel subsidy for PUV drivers to begin April 14 —LTFRB

By Brian Campued Following President Ferdinand R. Marcos Jr.’s announcement of new initiatives to cushion the impact of surging fuel prices in the country, the...

Palace firm on combatting fake news vs. PBBM’s health, admin

By Brian Campued Malacañang on Friday reiterated that rumors circulating online about the alleged deteriorating health of President Ferdinand R. Marcos Jr. are “fake news.” In...

PCG command post in Kalayaan Island now activated

By Brian Campued To commemorate the 84th Day of Valor on Thursday, the Philippine Coast Guard (PCG) officially activated its Coast Guard District Kalayaan Island...

PBBM hails pause in Middle East conflict; bolsters collab with private sector amid energy emergency

By Dean Aubrey Caratiquet On the heels of a reported two-week ceasefire between the United States and Iran, the Philippines welcomed the development as an...