The U.S. has become the fifth nation behind the U.K., Bahrain, Canada and Saudi Arabia to approve a coronavirus vaccine candidate for emergency use. The verdict from the drug regulator came even swifter than many expected amid the accelerated timeline.
What Happened: The U.S. Food and Drug Administration has authorized the emergency use of BNT162b2, the mRNA vaccine candidate developed by Pfizer Inc. PFE and its German partner BioNTech SE – ADR BNTX, for use in individuals aged 16 years and older, the companies said in a statement late Friday.
Despite some apprehensions, 16- and 17-year-olds were included in the emergency use authorizaton (EUA). An FDA panel, which reviewed the EUA application Friday, was divided over the prospect of giving the greenlight to this age group, as the clinical studies had included participants from 17 years of age onwards.
The allocation of the vaccine and its distribution will be managed by the U.S. Department of Defense in partnership with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention. Priority will be given according to the populations identified by CDC's Advisory Committee on Immunization Practices.
Why It's Important: The COVID-19 pandemic isn't showing signs of abating. According to the CDC, there are 63.3 active cases per 100,000 people in the country.
Assuming over 50% market share for BNT162b2 in the U.S. and a price of $30 per dose, Pfizer is likely to rake in revenues of $3.54 billion from the vaccine in 2021, according to SVB Leerink analyst Geoffrey Porges. The market share will decrease to 25% over time, as competition emerges, and prices will likely drop to $11-$15 per dose, he added. This puts revenues at $1.57 billion in 2024, Porges estimates.
The U.K. became the first nation to approve BNT162b2 on Dec. 2. Following mass vaccination in the nation, stray reports for severe allergic reactions have cropped up, giving rise to concerns.
What's Next: Pfizer and BioNTech said they will begin delivery of the first doses of the vaccine in the U.S. immediately, with delivery fulfilment expected to be completed in 2021.
Contractually, Pfizer is bound to supply 100 million doses in the U.S. for $1.95 billion, with the agreement also providing an option for the supply of an additional 500 million doses thereafter.
The companies plan to manufacture up to 50 million doses by year-end and up to 1.3 billion doses by the end of 2021.
Reuters reports that a first round of 2.9 million doses this month will likely include healthcare workers and seniors as the main recipients.
Pfizer and BioNTech also said they are gathering additional data and preparing to file a biologics license application for full approval, which they expect in 2021.
The European Medicines Agency's scientific committee for human medicines will conclude its assessment of Pfizer-BioNTech's vaccine during a special meeting on Dec. 29.
News of the approval came after U.S. markets closed for the week, and after the close of Friday's after-hours trading.
Pfizer shares closed the week at $41.12, and BioNTech slipped 1.73% to $127.30.
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