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Winnings of Pfizer PFE Q1 2021

A woman is holding a small bottle marked “COVID-19 Coronavirus Vaccine” sticker and a medical syringe in front of the Pfizer logo shown in this illustration, made on October 30, 2020.

Whereas Reuters

Pfizer said Tuesday it plans to submit its Covid-1

9 vaccine for full US approval to German drugmaker BioNTech later this month. If the FDA signs, the company will be able to sell the shot directly to consumers.

When it released its first-quarter financial results, the company also reported $ 3.5 billion in sales for the first quarter of its Covid-19 vaccine and reported profits and revenue that exceeded Wall Street expectations.

Here’s how Pfizer did against Wall Street expectations, according to Refinitiv averages:

  • Adjusted EPS: 93 cents per share against 77 cents expected
  • Revenue: $ 14.58 billion against $ 13.51 billion

The company now expects year-round sales of $ 26 billion from the vaccine, up from a previous estimate of about $ 15 billion.

Shares of Pfizer rose 1.4% after the news.

Revenues from Pfizer’s oncology, internal medicine, hospitals and rare diseases departments doubled during the quarter, according to the revenue report. The company’s inflammation and immunology department generated about $ 1 billion in sales, an increase of 9% over a year ago.

Pfizer reported double-digit sales growth for many of its cancer drugs, including Inlyta, Bosulif and Lorbrena.

The company received permission from the United States for its Covid vaccine in late December. Since then, the company has distributed millions of doses in the United States in order to deliver 300 million doses by the end of July.

It usually takes the Food and Drug Administration nearly a year or more to determine if a drug is safe and effective for use by the general public. But because of the once-a-century pandemic that killed nearly 600,000 Americans, the FDA allowed the use of the shots under an emergency permit or EUA.

The EUA grants conditional approval on the basis of bimonthly data. This is not the same as a Biologic or BLA license application, which requires six months of data and provides full approval.

The company also said it expects to apply to the EUA for a booster that could potentially protect against options in the second half of July, according to a slide presentation that completes the company’s profit release. He expects to apply for permission for his vaccine for young children and young children in September and infants in November.

On April 1, Pfizer and BioNTech announced that new data from their clinical trial 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 Burla said the new data positioned companies “to apply for a license for organic products to the US FDA.”

If the vaccine is fully approved, it starts Pfizer and BioNTech to start advertising the photos directly to consumers and change their prices. It also allows the shot to remain on the market after the pandemic ends and the United States is no longer considered an “emergency.”

This is an evolving story. Please check again for updates.

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