PFE Pfizer Inc

By Jared S. Hopkins and Matt Grossman 

Pfizer Inc. said a global late-stage trial evaluating its Covid-19 vaccine is almost fully enrolled with participants, but the drugmaker hasn't conducted the first review of whether it works safely.

Pfizer's Phase 3 trial seeking 44,000 volunteers needs fewer than 2,000 people to be fully enrolled, the company said Tuesday while announcing third-quarter earnings. The New York-based company also said that nearly 36,000 people in the trial received their second injection of either the two-dose vaccine or placebo.

Pfizer's experimental Covid-19 vaccine, which it is developing in partnership with Germany's BionTech SE, is among the most advanced shots from pharmaceutical companies working to help stem the global pandemic.

"We have reached the last mile here," Pfizer Chief Executive Albert Bourla said on a conference with analysts discussing earnings. "Let's all have the patience required for something so important for public health and the global economy."

Mr. Bourla said this month that the company could file for an emergency authorization to put the vaccine into public use in late November, assuming positive trial results, suggesting shots could be made available in the U.S. before the end of the year.

Pfizer said Tuesday an outside panel of experts hasn't performed the first review of whether the vaccine works safely, known as an interim analysis, which was planned once 32 study participants become infected with symptomatic Covid-19. The review is performed by an outside group of experts known as the data safety monitoring committee.

A week after subjects receive their second shot, researchers begin checking whether the vaccinated group develops symptoms more or less frequently than those who weren't vaccinated. In Pfizer's study, half the participants get a two-dose regimen of the vaccine three weeks apart, with the rest getting placebo shots. The Food and Drug Administration is requiring two months of observational safety data of study participants.

Pfizer has already spent nearly $2 billion on its Covid vaccine program. In July, Pfizer and BioNTech reached a $1.95 billion deal with the U.S. government to supply 100 million doses of the vaccine. AstraZeneca PLC, Moderna Inc. and Johnson & Johnson also have vaccines in advanced development.

Pfizer recorded third-quarter sales of $12.13 billion, compared with $12.68 billion in the same three-month period last year. Analysts surveyed by FactSet had forecast $12.31 billion of sales

The company's biopharma revenue grew by 3% to $10.22 billion as sales expanded for drugs such as blood thinner Eliquis, rare-disease drug Vyndaqel and arthritis treatment Xeljanz. Revenue from the company's Upjohn segment, which focuses on off-patent and generic drugs, declined by 18% to $1.92 billion.

Pfizer plans to spin off Upjohn in a combination with U.K.-based Mylan NV that will be called Viatris. In September, Pfizer and Mylan won approval from the European Commission for the deal, which is expected to close in the fourth quarter.

Pfizer said the pandemic dragged down its third-quarter revenue by approximately $500 million, or 4%, as it disrupted demand for some products in China and scrambled U.S. health-care visits that aren't related to the viral disease. Reduced doctor visits have thrown off prescribing patterns for some products, according to the company.

Pfizer's profit in the third quarter was 39 cents a share, compared with $1.36 a share in last year's third quarter. On an adjusted basis, its profit was 72 cents a share. Analysts had anticipated an adjusted profit of 70 cents a share.

The company said it expects to report full-year revenue between $48.8 billion and $49.5 billion, and an adjusted profit of $2.88 to $2.93 a share. The guidance doesn't assume revenue contributions from its Covid-19 vaccine.

Write to Jared S. Hopkins at jared.hopkins@wsj.com and Matt Grossman at matt.grossman@wsj.com

(END) Dow Jones Newswires

October 27, 2020 11:52 ET (15:52 GMT)

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