Drug maker Pfizer (NYSE:PFE) has announced that it plans to file for full U.S. approval of its COVID-19 vaccine at the end of May.
If the U.S. Food and Drug Administration (FDA) approves the application, Pfizer will be able to market its COVID-19 vaccine directly to consumers. The company announced plans for the regulatory application as it released its first-quarter financial results.
Pfizer reported $3.5 billion U.S. in first quarter sales of its COVID-19 vaccine and reported earnings and revenue that beat Wall Street expectations. Adjusted earnings per share came in at 93 cents U.S. versus 77 cents U.S. that analysts had expected.
Pfizer’s revenue totaled $14.58 billion U.S. versus $13.51 billion U.S. that had been expected. The company raised its forward guidance and now says it expects full-year sales of $26 billion U.S. from its COVID-19 vaccine, up from its previous forecast of about $15 billion U.S. in sales.
Shares of Pfizer rose 1.4% in pre-market trading on news of the quarterly results and FDA application.
