Multinational pharmaceutical and biotechnology firm Pfizer (PFE) and German biotechnology company BioNTech SE (BNTX) have submitted COVID-19 vaccine data on children five to less than 12 years of age to the U.S. Food and Drug Administration (FDA) for initial review.
BioNTech develops and manufactures immunotherapies for the treatment of allergies, infectious diseases, cancer and autoimmune disorders. Shares of the company declined nearly 10% on Tuesday but were up around 4% in early trade on Wednesday.
Meanwhile, Pfizer’s shares closed 1.2% lower on Tuesday but gained 0.4% in the pre-market trading session on Wednesday. (See Pfizer stock chart on TipRanks)
On September 20, the companies announced positive topline results from the pivotal Phase 2/3 trial, which included 2,268 participants in the age bracket of five to less than 12 years. The results were comparable to those recorded in a previous study by Pfizer and BioNTech in people who were 16 to 25 years old.
In the upcoming weeks, the companies plan to make a formal submission to request Emergency Use Authorization (EUA) of the vaccine in children five to less than 12 years of age. They also plan to submit the full Phase 3 trial data for scientific peer-reviewed publication.
Furthermore, other regulatory submissions, including to the European Medicines Agency (EMA), are also planned. (See BioNTech stock chart on TipRanks)
Notably, topline safety and immunogenicity results for the other two age cohorts from the trial — children six months to less than two years old and children two to less than five years old — are expected earliest by the fourth quarter.
On September 20, Citigroup (C) analyst Andrew Baum maintained a Hold rating on Pfizer with a price target of $43. In a research note to investors, the analyst said, “Investors should remain upbeat over the outlook for Pfizer’s COVID-19 vaccine revenues.”
Overall, the stock has a Hold consensus rating based on 2 Buys and 9 Holds. The average Pfizer price target of $45.55 implies 5.8% upside potential. Shares have gained 25.6% over the past year.
Last week, UBS analyst Eliana Merle reiterated a Hold rating on BioNTech with a price target of $300 (8.5% upside potential). The analyst expects the company to report earnings per share (EPS) of $11.42 in the third quarter.
Overall, the stock has a Moderate Buy consensus rating based on 4 Buys and 4 Holds. The average BioNTech price target of $373.14 implies nearly 35% upside potential. Shares have gained 313.6% over the past year.
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