(CNBC) US Food and Drug Administration has granted full approval of Pfizer-BioNTech Covid-19 shots.
The approval means that Pfizer and BioNTech become the first in the US to win full authorization by FDA, allowing the firms to market the shots directly to Americans.
The full approval will also allow Pfizer-BioNTech shots to stay in the market longer after the pandemic.
The full approval of the joint vaccine gives room for full vaccine mandates allowing more unvaccinated people to get the shots.
The decision comes when FDA officials have been under pressure by Federal health officials to grant full approval of the joint vaccine.
FDA cited high standards of safety, manufacturing quality, and effectiveness as key reasons it gave a full approval of the vaccine.
Pfizer-BioNTech vaccine was until Monday, under an Emergency Use Authorization, which was granted by FDA last year.
Pfizer and BioNTech expect to seek FDA approval of a third booster shot after Monday’s development.
Analysts say the full approval is beneficial to companies that may submit an application, and could even allow Pfizer and BioNTech to charge more for the shots.
PFE: NYSE is up +3.50%, BNTX: NASDAQ is up +10.02%.
