BREAKING: Pfizer And BioNTech Requests For FDA Emergency Use Authorization For #COVID-19 Vaccine

The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.

The final analysis from the trial found the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer and BioNTech said this week. The submission also includes safety data on about 100 children ages 12 to 15.

About 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds, the companies said in a news release, and 41% of global and 45% of US participants are ages 56 to 85.

Moderna, another pharmaceutical company, announced Monday that early clinical trial results show its vaccine is 94.5% effective. The company plans to apply to the FDA for authorization after it accumulates more safety data later this month.

Emergency use authorization, or EUA, from the FDA is not the same as full approval. An EUA allows products to be used under particular circumstances before all the evidence is available for approval. For an EUA, the agency says it will determine whether a product’s “known and potential benefits outweigh its known and potential risks.”