Pfizer said Tuesday it was planning to apply to German drug maker BioNTech for full US approval of its Covid-19 vaccine later this month. If the FDA signs out, the company can market the shot directly to consumers.
In its earnings report, Pfizer said its Covid-19 vaccine sales were $ 3.5 billion in the first quarter. Profits and revenues were reported that exceeded Wall Street expectations.
According to Refinitiv’s average estimates, Pfizer has outperformed Wall Street expectations as follows:
- Adjusted EPS: 93 cents per share compared to 77 cents expected
- Revenue: $ 14.58 billion versus $ 13.51 billion expected
The company now expects total annual sales of the vaccine to be $ 26 billion, compared to its previous forecast of approximately $ 15 billion.
Pfizer’s shares rose 1.3% in premarket trading.
Pfizer’s oncology, internal medicine, hospital and rare disease revenues grew double-digit for the quarter, according to earnings report. The company’s inflammation and immunology division had sales of approximately $ 1 billion, up 9% year over year.
Pfizer saw double-digit sales growth for many of its cancer drugs, including Inlyta, Bosulif, and Lorbrena.
The company received US approval for its Covid vaccine in late December. Since then, Pfizer has distributed millions of doses in the US with the goal of dispensing 300 million doses by the end of July.
It usually takes the Food and Drug Administration nearly a year or more to determine whether a drug is safe and effective for the general public. Due to the one-off pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.
The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval.
The company also expects to apply for an EUA for a booster shot in the second half of July, which could protect against Covid variants. Its vaccine is expected to be approved in September for infants and younger children and in November for infants.
On April 1, Pfizer and BioNTech announced that new data from their clinical study showed that the two-dose vaccine was safe and greater than 91% effective six months after the second dose. At the time, Pfizer CEO Albert Bourla said the new data would drive companies “to file a biologics license application with the US FDA.”
When the vaccine is fully approved, Pfizer and BioNTech can begin promoting the shots directly to consumers and changing prices. It also allows the shot to stay in the market once the pandemic is over and the US is no longer considered an “emergency”.