MANILA: The Philippines’ Food and Drug Administration (FDA) has authorised the emergency use of Pfizer Inc and BioNTech SE’s Covid-19 vaccine, reported Xinhua news agency, quoting FDA head Enrique Domingo on Thursday.
“Based on the totality of evidence available to date, including data from adequate and well-known controlled trials, it is reasonable to believe that the Pfizer-BioNTech Covid-19 vaccine may be effective to prevent, diagnose, or treat Covid-19,” Domingo said at an online briefing.
He added that “the known and potential benefits of the Pfizer vaccine when used to diagnose, prevent, treat Covid-19, outweigh the known and potential risks of said vaccine as of date.”
Domingo said the emergency use authorisation (EUA) for the Pfizer-BioNTech vaccine “is effective immediately.”
Pfizer applied for EUA on Dec. 23 last year.
Meanwhile, Domingo said China’s Sinovac Biotech applied for EUA on Wednesday.
“Pre-assessment” of the application is ongoing, he added.
Aside from Sinovac, the FDA has yet to approve the Covid-19 vaccines and EUA applications filed by AstraZeneca and Russia’s Gamaleya.
