Pfizer (PFE) - Get Pfizer Inc. Report shares were active Monday amid reports that the drugmaker could seek approval from the U.S. Food & Drug Administration to administer its 'Comirnaty' coronavirus vaccine to children between the ages of 5 and 11.
Multiple media reports suggest U.S. health officials could be ready to approve Pfizer's request if it's able to provide sufficient clinical data in the coming weeks that indicates its safety. If the vaccine, which was developed with Germany's BioNtech (BNTX) - Get BioNTech SE Sponsored ADR Report, is eligible for Emergency Use Authorization from the FDA, it could be cleared for broader use in children by the latter part of October.
"In a best-case scenario, given that timeline they've just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween," former FDA director Scott Gottlieb, who sits on the board of Pfizer, told CBS' 'Face the Nation' Sunday.
"If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they've collected," he added.
Pfizer shares were marked 2.3% lower in early trading Monday, reversing earlier pre-market gains, to change hands at $44.56 each, a move that would extend trim its six-month gain to around 27%.
The FDA issued its formal approval for Comirnaty on August 23 for use by all U.S. citizens over the age of 16. Emergency Use Authorization (EUA) for children between the ages of 12 and 15 was granted on May 10.
In late July, 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.