Pfizer & BioNTech Files BLA for Approval of COVID-19 Vaccine in Age Group 12-15

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) revealed on Thursday that they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to allow their COVID-19 vaccine, COMIRNATY, to be used on individuals aged 12 to 15.

Shares of the company closed 4.2% higher on Thursday at $61.25.

Supporting Data

The sBLA is supported by the updated longer-term follow-up data from the companies’ pivotal Phase 3 clinical trial. The trial included 2,228 participants aged 12 through 15.

In the trial, the vaccine demonstrated a favorable safety profile after a two-dose series of the Pfizer-BioNTech vaccine (30-µg per dose), which showed 100% effectiveness against COVID-19, and was measured seven days through over four months after the second dose.

Approvals

In the coming weeks, the companies intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities globally.

In May 2021, the FDA authorized the vaccine for emergency use for individuals aged 12 to 15 years. Markedly, this is the only COVID-19 vaccine authorized for this age group in the U.S. Additionally, the vaccine is currently available to individuals aged 12 to 15 in the European Union under a Conditional Marketing Authorization.

Wall Street’s Take

Recently, Cantor Fitzgerald analyst Louise Chen reiterated a Buy rating on the stock and increased the price target to $75 (22.45% upside potential) from $61.

The rest of the Street is cautiously optimistic about Pfizer, with a Moderate Buy consensus rating based on 7 Buys and 10 Holds. The average Pfizer price target of $55.18 implies 9.9% downside potential to current levels. Shares have increased 61.1% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, Pfizer stock is at risk mainly from three factors: Tech and Innovation, Ability to Sell, and Macro & Political, which contribute 25%, 25%, and 17%, respectively to the total 24 risks identified for the stock.