FDA grants EUA to Moderna COVID-19 vaccine

The Philippines' Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Moderna's COVID-19 vaccine, making it the seventh vaccine to receive EUA in the country.

FDA Director General Eric Domingo stated that the vaccine's benefits outweigh its potential risks and that interim data from ongoing Phase 3 trials show an overall efficacy rate of over 94 percent in preventing COVID-19.

Domingo also noted that the vaccine's efficacy rate is consistently above 80 percent in all age groups above 18 years old, including health workers, individuals with comorbidities, and the elderly.

The FDA's review of Moderna's application was completed in 10 days due to complete documentation, shorter than the usual 21-day period.

The vaccine requires two doses administered four weeks apart and needs storage temperatures between -25°C to -15°C.

Reported adverse effects during clinical trials and actual use were mostly mild and transient.