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FDA chief: Good chance Pfizer-BioNTech vaccine will get Philippines' emergency use authority


The Pfizer-BioNTech COVID-19 vaccine has a good chance of securing an emergency use authorization (EUA) in the Philippines if it applies for one, Food and Drug Administration director general Eric Domingo said Thursday.

"Maganda po ang kaniyang chance na magkaroon din ng EUA dito kung mag-apply siya. Unang-una, 'yun pong counterpart ng FDA sa United Kingdom ay itinuturing natin na isang stringent regulatory authority 'yan. Alam po nating sinuri nila nang husto ang mga datos," Domingo said in an online interview.

Nonetheless, he said the FDA would still ask important prerequisites for Pfizer-BioNTech such as information on the "stability" of the product should it be shipped to the country, considering the local climate and storage requirements for the vaccine.

"Hihingi rin po tayo ng datos para maipakita na kung sa kanilang mga tinesting eh mayroon bang medyo mga kalahi natin, mga Asians or mga Filipino, para makita lamang po na walang pagkakaiba ang kaniyang safety at efficacy sa iba-ibang lahi o ethnic groups," Domingo added.

On Wednesday, the Pfizer-BioNTech COVID-19 vaccine was approved for use in the UK. Its rollout is expected next week.

Domingo said COVID-19 vaccines may be ready for distribution in the Philippines by March 2021.

COVID-19 vaccines that would get an EUA in other countries would likely be the ones to get first dibs for the same document in the Philippines, according to the official.

An EUA will reduce the processing time for the approval of the vaccines for local use from six months to as fast as 21 days.

"Kung mag-aapply po sila sa atin within the month, then its possible that we will be able to issue also the EUA within another three to four weeks. So, sa January," Domingo said.

"Pag ganoon po, maaari na po siguro mag-umpisa ang proseso ng pag-procure ng pamahalaan ng bakuna para makakuha sila ng allotment at supply at madala sa Pilipinas," he added. -MDM, GMA News

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