MANILA – The Philippines' Food and Drug Administration (FDA) has authorised the emergency use of Pfizer-BioNTech's Covid-19 vaccine, reported the Xinhua news agency, quoting FDA head Enrique Domingo today.
"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 the EUA on December 23.
Meanwhile, Domingo said China's Sinovac Biotech applied for the EUA yesterday. Pre-assessment of the application is ongoing, he added.
Aside from Sinovac, the FDA has yet to approve Covid-19 vaccine and EUA applications filed by AstraZeneca and Russia's Gamaleya. – Bernama, January 14, 2021
