FDA: Pfizer-BioNTech has good chance of getting EUA for COVID-19 vaccine | Inquirer News
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FDA: Pfizer-BioNTech has good chance of getting EUA for COVID-19 vaccine

By: - Reporter / @DYGalvezINQ
/ 02:58 PM December 03, 2020

MANILA, Philippines — The coronavirus disease (COVID-19) vaccine produced by Pfizer-BioNTech has a good chance of getting an emergency use authorization (EUA) considering it has been approved by the United Kingdom, the Food and Drug Administration (FDA) said Thursday.

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FDA Director-General Eric Domingo said UK’s approval of the vaccine means that the agency’s counterpart in the said country has thoroughly scrutinized the data on the vaccine.

The pharmaceutical firm, however, is yet to apply for EUA in the Philippines and present its data and documents.

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“Maganda ang kanyang [Pfizer BioNTech] chance na magkaroon ng EUA dito kung mag apply siya. ‘Yung counterpart ng FDA sa UK ay tinuturing nating isang stringent regulatory authority ‘yan,” Domingo said in an online forum.

(They have a good chance of getting a EUA since the counterpart of the FDA in the UK is one of what we consider as a stringent regulatory authority.)

“Alam po natin na sinuri nila ng husto ang mga datos,” he added.

(We know that they scrutinize data thoroughly.)

Should Pfizer-BioNTech apply for a EUA in the country, the Philippine government would need to gather information on the stability of the products, especially during delivery.

The Philippines would also ask for data on whether the testing subjects of the vaccine, during its clinical trial, had included Asians or even Filipinos.

The FDA can grant a pharmaceutical firm an EUA within 21 to 28 working days, granted that the applicant presents a complete application, Domingo said.

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Under Executive No. 121, President Rodrigo Duterte has allowed the FDA to grant EUA to expected COVID-19 vaccines that will be made available in the Philippines.

According to the EO, conditions for the issuance of EUA to COVID-19 drug or vaccine are the following:

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 for diagnosing, preventing, or treating COVID-19

/MUF
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TAGS: COVID-19 Vaccine, EUA, FDA, Pfizer
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