Pfizer, BioNTech Reveal Topline Results of COVID-19 Vaccine Phase 3 Clinical Trial


Pfizer (PFE) and BioNTech (BNTX) have revealed topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals of age 12 through 15 years.

As per the topline analysis update, the companies’ pivotal Phase 3 trial demonstrated that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose. Notably, the trial showed high efficacy across gender, race and ethnicity demographics, obesity and comorbidity status.

Update on Approvals 

The companies expect the data to support their planned supplemental Biologics License Application (BLA) to be submitted to the FDA. The FDA’s approval will allow the use of the vaccine in individuals 12 years and older.

Markedly, in May 2021, the FDA authorized the vaccine for emergency use in individuals aged 12 through 15 years. Additionally, as per the companies’ plan, the data will be submitted to get regulatory approvals for this age group in other countries where emergency use authorizations have already been granted. (See Pfizer stock charts on TipRanks)

Official Comments

The CEO of BioNTech, Ugur Sahin, said, “These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 through 15 years of age. The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations.”

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Wall Street’s Take

On November 18, BMO Capital analyst Evan Seigerman initiated coverage on Pfizer with a Buy rating and a price target of $60 (17.2% upside potential).

Seigerman foresees a “longer-than-projected tail” from the COVID vaccine business, along with a “rich pipeline” and “financially solid” fundamentals.

The rest of the Street is cautiously optimistic about Pfizer and has a Moderate Buy consensus rating based on 4 Buys and 9 Holds. The average Pfizer price target of $47.67 implies 6.9% downside potential to current levels. Shares have increased 40.2% over the past year.

Risk Analysis

According to the new TipRanks’ Risk Factors tool, the 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.

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