Shares of Pfizer Inc. /zigman2/quotes/202877789/composite PFE +2.15% rose 0.3% and BioNTech SE /zigman2/quotes/214419716/composite BNTX -0.52% rallied 1.3% in premarket trading, after the drug makers said three doses of it COVID-19 vaccine for children aged six months to five years "met all immunobridging criteria" required for Emergency Use Authorization by the U.S. Food and Drug Administration. The companies said the vaccine showed 80.3% efficacy in an analysis of three doses at a time when omicron was the dominant variant, with a favorable safety profile, similar to placebo. "The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains," said BioNTech Chief Executive Ugur Sahin. "We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks." Pfizer's stock has declined 11.1% and BioNTech shares have dropped 36.8% year to date through Friday, while the S&P 500 /zigman2/quotes/210599714/realtime SPX +0.36% has lost 18.1%.