Pfizer plans to file for full approval of its COVID-19 vaccine at the end of this month.
This morning, Pfizer released its first-quarter financial results, and its plans to file for full approval.
If the FDA signs off, the company will be able to market the shot directly to consumers.
It also allows the shot to stay on the market once the pandemic is over, and the U.S. is no longer considered in an "emergency."
Pfizer, buoyed by a huge jump in sales for its COVID-19 vaccine and solid performance across most of the company, is hiking its 2021 financial forecast sharply after blowing past Wall Street expectations for the first quarter.
The New York drugmaker and its German partner on the vaccine, BioNTech, continue to sign contracts with multiple countries for their two-dose shot. They reported $3.46 billion in first-quarter sales and now expect to rake in roughly $26 billion over the year, up from their prior forecast of about $15 billion.
Pfizer has said that this year it can produce 2 billion doses of the vaccine, including 200 million doses promised for the U.S. by the end of May.
AP wire services contributed to this report.