Pfizer (PFE) - Get Pfizer Inc. Report shares traded higher Thursday after the U.S. Food & Drug Administration formally approved its coronavirus vaccine for booster shots in older and at risk Americans.
The FDA said individuals over the age of 65, those between 18 and 64 who are at "high risk of severe COVID-19", and adults whose "frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19" would be eligible for a third dose of the "Comiranty" vaccine once six months had passed from the second dose.
The decision, which will need to be followed-up by similar approval from the Centers for Disease Control and Prevention, could pave the way for both a specific booster shot campaign in the coming weeks and a broader program during the winter months if similar permissions are granted to vaccine makers like Moderna (MRNA) - Get Moderna, Inc. Report and Johnson & Johnson (JNJ) - Get Johnson & Johnson (JNJ) Report.
The CDC's Advisory Committee on Immunization Practices will likely vote to approve the Pfizer booster shot later today.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day," said Acting FDA Commissioner Janet Woodcock. "As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
Pfizer shares were marked 1.15% higher in early trading Thursday to change hands at $44.44 each, a move that would extend the stock's year-to-date gain to around 20.8%.
“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Pfizer CEO Albert Bourla. "We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated."
Earlier this summer, 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.