A woman holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” label and a medical syringe in front of the Pfizer logo shown in this illustration taken October 30, 2020.
Given Ruvic | Reuters
Pfizer said Tuesday that it plans to file for full U.S. approval of its Covid-1
In announcing its first-quarter financial results, the company also reported $ 3.5 billion in sales in the first quarter of its Covid-19 vaccine, reporting earnings and revenue that beat Wall Street expectations.
This is how Pfizer works compared to what Wall Street expected according to average estimates compiled by Refinitiv:
- Adjusted EPS: 93 cents per Stock versus 77 cents expected
- Revenue: DKK 14.58 billion $ Mod 13.51 billion. $ Expected
The company now expects a full year of sales of DKK 26 billion. Dollars from the vaccine compared to its previous forecast of about 15 billion. $.
Shares in Pfizer rose 1.4% after the news.
Revenue from Pfizer’s oncology, internal medicine, hospital and rare disease units all rose by double digits during the quarter, according to the revenue report. The company’s inflammation and immunology unit generated about 1 billion. $ On sale, up 9% from a year ago.
Pfizer reported double-digit growth in sales of many of its cancer drugs, including Inlyta, Bosulif and Lorbrena.
The company received US approval for its Covid vaccine in late December. Since then, the company has distributed millions of doses to the United States with the goal of delivering 300 million doses by the end of July.
It usually takes the Food and Drug Administration nearly a year or longer to determine if a drug is safe and effective for public use. But because of the pandemic that once in the century that killed nearly 600,000 Americans, the FDA allowed the use of the shots during an emergency use approval or EUA.
An EUA provides conditional approval based on two months of data. It is not the same as a biological license application or BLA, which requires six months of data and ensures full approval.
The company also said it expects to apply for an EUA for a booster shot that could potentially protect variants in the second half of July, according to a slide presentation that came with the company’s earnings release. It expects to apply for a permit for the vaccine for use in young children and young children in September and infants in November.
On April 1, Pfizer and BioNTech announced that new data from their clinical trials showed that their two-dose vaccine was safe and more than 91% effective six months after the second dose. At the time, Pfizer CEO Albert Bourla said the new data places companies “to submit a biological license application to the US FDA.”
If the vaccine is fully approved, it sets the stage for Pfizer and BioNTech to start announcing the shots directly to consumers and changing pricing. It also allows the shot to remain on the market once the pandemic is over and the United States is no longer considered an “emergency.”
This is a story that is evolving. Please see again for updates.