FDA grants emergency use authorization for Pfizer COVID-19 vaccine
MANILA, Philippines — The country’s Food and Drug Administration (FDA) has granted an emergency use authorization for the COVID-19 vaccine from Pfizer.
“After a thorough review of the currently available data by medical and regulatory experts, the FDA today is granting an emergency use authorization to Pfizer-BioNTech COVID-19 vaccine,” FDA director-general Eric Domingo said in a visual press briefing on Thursday.
According to Domingo, the interim data from the phase 3 trial shows that the vaccine from Pfizer has an efficacy of 95 percent in the study population and at least 92 percent among all racial groups.
He said the application from the American pharmaceutical firm satisfied the requirements for acquiring an EUA in the Philippines.
“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,” he noted.
He added that “the known and potential benefits of the vaccines from Pfizer, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risk of the said vaccine as of date.”
According to the FDA chief, COVID-19 vaccines from Pfizer would require storage with temperature of -80 to -60 degree Celsius prior to dilution.
He said that the Pfizer-BioNTech vaccines “shall be administered only by vaccination providers, and used only to prevent COVID-19 in individuals ages 16 and older.”
In the absence of an agreement with the Department of Health or the National Task Force against COVID-19, Pfizer Inc. Philippines shall provide appropriate cold chain requirements for storage, transport, and handling until the vaccines are delivered to inoculation sites, according to Domingo.
Domingo, however, clarified that the granting of an EUA is not a marketing authorization or a certificate of product registration, hence it cannot be used to market the vaccine commercially.
CFC
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