Pfizer-BioNTech's Covid Vaccine For Kids Under 5 Demonstrates Efficacy Of 80.3% In Phase 2/3 Trial

Pfizer Inc. (PFE) and BioNTech SE (BNTX), on Monday, announced encouraging topline results of a Phase 2/3 trial evaluating a third 3-g dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age.

Following a third dose, the vaccine demonstrated strong immune response, with a favorable safety profile similar to placebo. Vaccine efficacy, a secondary endpoint in this trial, was 80.3 percent.

Ugur Sahin, CEO and co-founder of BioNTech, said, "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."

In February 2022, the companies had initiated a rolling submission for Emergency Use Authorization (EUA) of their COVID-19 vaccine in children 6 months to under 5 years of age, following a request by the U.S. Food and Drug Administration (FDA). At that time, a two-dose series was determined to be well-tolerated in this age group.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. The vaccine is authorized under Emergency Use Authorization for individuals 12 years of age and older and in individuals 5 through 11 years of age.

The Pfizer-BioNTech COVID-19 vaccine, under brand name Comirnaty, is approved for use in individuals of ages 16 and older.

Shares of Pfizer are currently trading in pre-market at $52.65, up $0.18 or 0.34 percent from the previous close.

Shares of BioNTech are currently trading in pre-market at $166.01, up $3.01 or 1.85 percent from the previous close.

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