Pfizer plans to file for full FDA approval of Covid vaccine at the end of May 2021

[Stone]

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month

CNBC | May 4, 2021


Pfizer said Tuesday it plans to file for full U.S. approval of its Covid-19 vaccine with German drugmaker BioNTech at the end of this month. If the FDA signs off, the company will be able to market the shot directly to consumers.

In its earnings report, Pfizer said first-quarter sales of its Covid-19 vaccine was $3.5 billion, roughly 24% of its revenue for the quarter. Its profit and revenue beat Wall Street’s expectations.

Here’s how Pfizer did compared with what Wall Street expected, according to average estimates compiled by Refinitiv:

Adjusted EPS: 93 cents per share vs. 77 cents expected
Revenue: $14.58 billion vs. $13.51 billion expected

The company now expects full-year sales of $26 billion from the vaccine, up from its previous forecast of about $15 billion. It expects an adjusted pretax profit in the high 20% range of revenue for the vaccine.

Shares of Pfizer rose 1.3% in premarket trading.

“Based on what we’ve seen, we believe that a durable demand for our Covid-19 vaccine, similar to that of the flu vaccines, is a likely outcome,” Pfizer CEO Albert Bourla told investors on an earnings call.

Revenue from Pfizer’s oncology, internal medicine, hospital and rare disease units rose by double digits during the quarter, according to the earnings report. The company’s inflammation and immunology unit generated about $1 billion in sales, a 9% increase from a year earlier.

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

The company received U.S. authorization of its Covid vaccine in late December. Since then, Pfizer has distributed millions of doses to the U.S., with the goal of delivering 300 million doses by the end of July.

During an earnings call, Bourla addressed a recent slow down in the pace of vaccinations in the U.S.

He said it is “normal” as more people get vaccinated and the people leftover are those reluctant to get the shots. He expects an increase in vaccinations once the FDA authorizes the shots for kids ages 12 to 15, which is expected to happen this month.

Usually, it takes the Food and Drug Administration nearly a year or longer to determine whether a drug is safe and effective for use in the general public. Due to the once-in-a-century pandemic, which has killed nearly 600,000 people in the United States, the FDA permitted the use of the shots under an Emergency Use Authorization.

The authorization grants conditional approval based on two months of data. It’s not the same as a Biologic License Application, which requires six months of data and secures full approval.

The company also said it expects to apply for an EUA for a booster shot that could protect against Covid variants during the second half of July, according to a slide presentation that accompanied the company’s earnings release. It expects to apply for authorization for its vaccine for use in toddlers and younger children in September and infants in November.

It also expects vaccine safety data for pregnant women in late July.

On April 1, Pfizer and BioNTech announced that new data from their clinical trial showed 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 positions the companies “to submit a Biologics License Application to the U.S. FDA.”

If the vaccine is fully approved, it sets the stage for Pfizer and BioNTech to begin advertising the shots directly to consumers and change its pricing. 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.”