FDA Gives Emergency Use Nod to Pfizer/BioNTech COVID-19 Vaccine in Adolescents


Pfizer (PFE) and BioNTech (BNTX) have received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine to be used in adolescents.

The expanded approval now includes the 12 to 15 age group. This is the first COVID-19 vaccine to receive U.S. approval for this age group.

Pfizer Chairman and CEO Albert Bourla said, “Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year.” (See Pfizer stock analysis on TipRanks)

Bourla added, “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible.”

This approval is based on results from a Phase 3 clinical trial which showed 100% efficacy in participants, robust antibody responses, and a well-tolerated profile.

Next, based on the EUA, the immunization practices’ advisory committee of the U.S. Center for Disease Control and Prevention will meet to discuss recommendations for use of the vaccine in adolescents.

Additionally, a study is underway to assess the safety and efficacy of the vaccine in children ages 6 months to 11 years. A EUA application for this age group is expected in September.

On May 5, Barclays analyst Carter Gould reiterated a Hold rating on the stock and increased the price target to $40 from $37.

After Pfizer’s “Solid” Q1 performance, Gould expects a substantial reset on COVID-19 expectations from the stock, based on raised guidance and an expected 2.5 billion vaccine dose production in 2021.

Based on 1 Buy and 10 Holds, consensus on the Street is that Pfizer is a Hold. The average analyst price target of $42.27 implies 6% upside potential. Shares have gained about 7.1% over the past year.

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