Pfizer now hopes to tell U.S. regulators how well its COVID-19 vaccine works in the littlest kids by late May or early June.
Pfizer is testing three extra-small doses of its vaccine in children under 5 after two shots didn't prove quite strong enough. Initial results had been expected last month but the company laid out the latest timeline Tuesday during its discussion of quarterly financial results.
Currently in the U.S., only children ages 5 or older can be vaccinated, using Pfizer’s vaccine -- leaving 18 million younger tots unprotected.
Rival Moderna hopes to be the first to offer vaccinations for the youngest children. Last week, it filed with the Food and Drug Administration data it hopes will prove two of its low-dose shots work in children younger than 5. Moderna also has filed FDA applications for older kids, although the agency hasn’t ruled on them.
The FDA already has set tentative dates in June to publicly review data on COVID-19 vaccines for tots under 5, from either or both companies.
COVID-19 vaccine and treatment sales helped Pfizer breeze past Wall Street's first-quarter expectations, as the drugmaker's profit grew 61%.
The coronavirus vaccine Comirnaty brought in more than $13 billion in sales in the quarter, and the company is still trying to expand the market for the preventive shots.
The pill treatment Paxlovid, which launched late last year, added another $1.5 billion in the first quarter.
All that helped company revenue swell 77%, compared to last year's quarter, when vaccine sales were still ramping up.
Overall, Pfizer on Tuesday posted net income of $7.86 billion and adjusted earnings of $1.62 per share in the first quarter.
That easily topped the $1.49 per share projected by industry analysts, according to a survey by FactSet.
Revenue was $25.66 billion, also beating Wall Street expectations for $24.1 billion.
Pfizer's COVID-19 vaccine launched in late 2020 and became the drugmaker’s top selling product by last year’s second quarter.
Pfizer books the vast majority of revenue from Comirnaty and splits profit, as well as the cost to make and distribute the vaccine, with development partner BioNTech.
Sales of that vaccine topped analyst expectations for the quarter, but revenue from Paxlovid fell short.
However, sales of the treatment are expected to pick up later this year, and President Joe Biden's administration is pushing to expand access to Paxlovid.
“We are seeing strong signs for increasing demand for Paxlovid,” Chairman and CEO Albert Bourla told analysts Tuesday.
He added that Pfizer booked only a small portion of revenue in the first quarter from the roughly 6 million doses it has shipped so far. He noted that international sales will be booked in the second quarter.
Revenue from both products will likely wind up exceeding forecasts, Mizuho Securities USA analyst Dr. Vamil Divan said in a research note. He noted that current projections only include contracts the company signed as of mid April.
During a Tuesday conference call to discuss the quarter, another analyst asked Pfizer executives about reports of COVID-19 recurring in patients after they have completed a Paxlovid treatment course.
Company officials said early data from outside clinical trials shows that these recurrences have been reported in less than 1 in 3,000 patients. They noted that patients with compromised immune systems can carry the virus for long periods of time, and Pfizer will study whether extended treatment courses may be appropriate in some cases.
Pfizer on Tuesday also revised the 2022 earnings forecast it debuted in February to reflect an accounting policy change. It now expects adjusted earnings of $6.25 to $6.45 per share.
That's down a dime on both ends of the range from its previous forecast for $6.35 to $6.55 per share.
Analysts forecast earnings of $7.14 per share.
Shares of Pfizer Inc., based in New York, climbed nearly 2% to $49.19 Tuesday.
Pfizer’s stock hit an all-time high price of $61.71 on Dec. 20. But that price has fallen 18% so far this year, a steeper drop than the roughly 13% decline of the Standard & Poor’s 500 index.