“After a rigorous and thorough review by regulatory and medical experts using currently available published and unpublished data, the FDA is granting emergency use authority for Moderna,” FDA director general Eric Domingo said during the Kapihan sa Manila Bay virtual forum yesterday.
“It has been decided that all conditions for an EUA are present and that the benefit of using the Moderna vaccine outweighs the known and potential risks,” Domingo added.
He said an EUA is not a marketing authorization and cannot be used to market Moderna commercially.
The FDA received Moderna’s application for EUA on April 26.
Based on clinical trials, Domingo said Moderna vaccine has an efficacy rate of over 94 percent in preventing COVID and over 80 percent efficacy among age groups above 18 years as well as special groups such as health care workers, people with comorbidities and the elderly.
Moderna is now widely used in the US and Europe.
Recorded adverse events following the use of the vaccine were mostly mild and transient, Domingo said.
He said vaccinees are closely monitored for possible allergic and adverse reactions.
This story is from the May 06, 2021 edition of The Philippine Star.
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This story is from the May 06, 2021 edition of The Philippine Star.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 8,500+ magazines and newspapers.
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