MANILA – The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Moderna’s Covid-19 vaccine after a thorough review by the country’s medical and regulatory experts.
“It is decided that all conditions for an EUA are present and that the known and potential benefits of using the Moderna vaccine, when used to prevent Covid-19, outweigh the known potential risks of said vaccine as of date. Interim data from ongoing Phase 3 trials of the vaccine show that the vaccine has an overall efficacy rate of over 94 percent in preventing Covid-19” FDA Director General Eric Domingo said during an online media forum Wednesday.
“It only took us 10 days [to approve the EUA application] because they have complete documents,” Domingo said.
Domingo noted that the vaccine’s efficacy rate is consistently above 80 percent in all age groups above 18 years old, including special groups like the health workers, individuals with comorbidities, and the elderly.
The vaccine is given in two doses, four weeks apart. It requires -25°C to -15°C storage temperature.
The reported adverse effects during the clinical trials and actual use were mostly mild and transient — similar to common reactions expected after vaccination.
It is the seventh vaccine granted EUA in the country, together with the vaccines from AstraZeneca, Sinovac Biotech, Gamaleya Institute, Johnson & Johnson, Bharat Biotech and Pfizer-BioNTech. (PNA)