Pfizer (PFE) - Get Pfizer Inc. Report shares surged higher Monday after the U.S. Food & Drug Administration issued its formal approval for the drugmaker's coronavirus vaccine in a move that marks the agency's first full authorization since granting emergency use permission late last year.
The FDA said the vaccine, which Pfizer produces alongside its German partner BioNTech (BNTX) - Get BioNTech SE Sponsored ADR Report, can now be marketed at "Comiranty" and will be eligible for use by all U.S. citizens over the age of 16. The decision could also pave the way for more formal vaccine mandates from companies and organizations around the country -- including the U.S. military -- as Delta-variant infections continue to accelerate.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated." she added. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Pfizer shares were marked 4.5% higher in early Monday trading to change hands at $50.92 each, a move that would extend the stock's year-to-date gain to around 38%.
BioNTech's U.S.-listed shares were marked 9.2% higher at $379.90 each.
Last month, Pfizer said sales of its vaccine, first labelled as BNT162b2 when it was granted Emergency Use Authorization late last year, could reach $33.5 billion this year as it boosted it 2021 earnings forecast to between $3.95 and $4.05 per share.
Looking into 2022, analysts see COIVD vaccine revenues for both groups rising to around $14 billion, with annual sales of around $5 billion thereafter.
Earlier Monday, Pfizer also agreed to pay $18.50 per share, in cash, for the Cambridge, Mass.-based biotech Trillium Therapeutics, a 204% premium to the stock's Friday closing price. Pfizer invested $25 million into the group last year.
Trillium's drug portfolio includes biologics treatments that "enhance the ability of patients’ innate immune system to detect and destroy cancer cells", Pfizer said.
Oncology sales were Pfizer's second-largest top line contributor over the three months ending in June, with revenues rising 19% from the same period last year to $3.145 billion. The division's stable includes brand such as Ibrance, its biggest seller, Inlyta and Sutent.