The Food and Drug Administration (FDA) has given its full approval of the Pfizer-BioNTech COVID-19 vaccine, calling it a “key achievement for public health.”
The two-dose vaccine is now fully approved for people ages 16 and older. For those who are ages 12-15 and for those who are immunocompromised, the vaccine is available under an FDA emergency use authorization. The FDA says the approval means “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.”
Back in December of 2020, the FDA allowed the Pfizer COVID-19 vaccine to be used under an emergency use authorization. Pfizer and BioNTech applied for full FDA approval in May of this year. The process of final approval, outlined by the FDA, requires an analysis of the drug’s benefits — which also examines its risks and looks at clinical trials from the drugmakes. A lot of this was already completed when the FDA authorized the vaccine’s emergency use.
But among the measures the FDA required for full approval that weren’t required for emergency use were data on how people fared six months after being fully vaccinated. The FDA also inspected manufacturing facilities in the intervening months.
Since 2020, investors have been rallying behind shares of Pfizer (PFE) and BioNTech (BNTX), two companies that were poised to play a crucial role in helping bring an end to a devastating pandemic. Those bets have paid off.
On Monday, after the FDA approval was announced, Pfizer’s shares gained 2.5% while BioNTech’s stock jumped 9.6%.
Vaccines usually aren’t the most profitable product for Big Pharma, particularly when compared to drugs used to combat chronic conditions. But the scale of the COVID-19 pandemic is generating tons of revenue.
In a note published on Monday, Morningstar analyst Karen Andersen said she sees sales of the Pfizer vaccine reaching $35 billion in 2021 and $39 billion in 2022. After that, she forecasts $2 billion in annual sales, as the most vulnerable continue to receive booster shots.
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