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Pfizer-BioNTech’s COVID-19 Vaccine Bags Full FDA Approval

The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) of Pfizer (PFE) and BioNTech SE’s (BNTX) COVID-19 vaccine COMIRNATY for people aged 16 years and older. COMIRNATY is the first COVID-19 vaccine approved by the regulator.

The FDA granted Emergency Use Authorization (EUA) to the vaccine on December 11, 2020. Headquartered in Manhattan, Pfizer is a multinational pharmaceutical and biotechnology firm. BioNTech is a biotechnology company based in Germany that makes active immunotherapies.

COMIRNATY’s approval was based on the companies’ submission of a comprehensive data package, which comprised longer-term follow-up data from the Phase 3 trial. It also included the facilities and manufacturing data needed for licensure. (See Pfizer stock chart on TipRanks)

BioNTech and Pfizer submitted the BLA for the vaccine in May 2021. The FDA granted the application Priority Review in July 2021. (See BioNTech stock chart on TipRanks)

The Chairman and CEO of Pfizer, Albert Bourla, said, “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval.”

Pfizer’s shares gained 2.5% on Monday. The stock rose another 0.4% in after-hours trading to finally close at $50.14. Meanwhile, BioNTech’s shares closed 9.6% higher at $382.10.

Last week, Cantor Fitzgerald analyst Louise Chen maintained a Buy rating on Pfizer and raised the price target to $61 from $53 (22.2% upside potential). In a research note to investors, the analyst said, “Pfizer’s pipeline advancements and product sales continue to exceed expectations.”

Overall, the stock has a Moderate Buy consensus rating based on 3 Buys and 8 Holds. The average Pfizer price target of $46.64 implies 6.6% downside potential. Shares of the company have gained nearly 48% over the past six months.

According to TipRanks’ Smart Score rating system, Pfizer scores a 9 out of 10, suggesting that the stock is likely to outperform market averages.

On August 23, Canaccord Genuity analyst Arlinda Lee reiterated a Buy rating on BioNTech and increased the price target to $450 from $240 (17.8% upside potential).

The analyst said, “As SARS CoV-2 transitions to endemic, so too does substantial vaccine revenue, enabling BNTX to continue to advance and expand its diverse immunotherapy pipeline.”

Overall, the stock has a Moderate Buy consensus rating based on 4 Buys, 4 Holds and 1 Sell. The average BioNTech price target of $320.44 implies 16.1% downside potential. The company’s shares have gained 439.3% over the past year.

According to TipRanks’ Smart Score rating system, BioNTech scores an 8 out of 10, suggesting that the stock is likely to outperform market averages.

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