‘As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,’ says the FDA’s acting head, Janet Woodcock.
Moderna (MRNA) – Get Report shares moved higher Friday, with Pfizer (PFE) – Get Report adding to recent gains, after the Food and Drug Administration approved coronavirus vaccine booster shots for immunocompromised individuals.
The FDA amended its original Emergency Use Authorization, first granted in December of last year, to include both recipients of solid organ transplants and patients considered to have compromised immune systems. The decision will need a sign-off from Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which is scheduled to meet later today.
Media reports suggest the FDA will issue a final approval for both vaccines — as well as the single-dose treatment made by Johnson & Johnson — within the coming weeks.
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease,” said acting FDA Commissioner Janet Woodcock. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines.”
Moderna shares were marked 2.1% higher in early trading Friday to change hands at $400.41 each after hitting an all-time high of $497.49 earlier this week.
Pfizer shares were marked 1.7% higher at $48.05 each while the U.S. listed shares of BioNTech (BNTX) – Get Report, which developed the COVID vaccine alongside the New York-based pharma giant, jumped 3.33% to $386.50 each.
Last week, Moderna posted stronger-than-expected second quarter earnings of $6.46 per share, up from a 31 cents per share loss for the same period last year, as vaccine sales surged to $4.2 billion.
Pfizer, for its part, said sales of its BNT162b2 vaccine, which it developed alongside its German partner, BioNTech BNTX, 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.