Pfizer hopes to be first U.S. drugmaker to unveil successful data from Covid vaccine trial
Reuters:
Drugmaker Pfizer Inc said on Tuesday it was not yet ready to release data from the advanced stage trial of the COVID-19 vaccine candidate it is developing with BioNTech SE in Germany.
Pfizer said in a presentation that the independent monitor that will determine whether the trial was successful or not has yet to perform interim efficacy analyzes. Chief Executive Albert Bourla previously said the company may release data on whether the vaccine is effective or not as early as this month.
Shares were flat at $ 37.93 before the opening bell.
US President Donald Trump had said a vaccine could be available ahead of the Nov. 3 election, but in recent weeks his administration has stressed it will be ready this year.
Pfizer hopes to be the first U.S. drugmaker to unveil successful data from an advanced COVID-19 vaccine trial, before rival Moderna Inc. Pfizer and BioNTech launch their Phase 3 study of 44,000 volunteers on their candidate vaccine at the end of July.
The data watchdog is expected to make its first assessment of the vaccine’s performance after 32 trial participants were infected with the novel coronavirus.
Healthcare investor Brad Loncar said it was difficult to draw a positive or negative conclusion because the trial has yet to have its first interim review.
“I think that means the overall infection rate is much lower than what Pfizer initially estimated,” Loncar said. “So the trial is just a little slower than they thought.”
As the pandemic weakens demand for some Pfizer therapies and hurts global economies, investors are keen to see data from the advanced stage study of the vaccine candidate under development with BioNTech.
The company also said that if the trial is successful, it still intends to file an emergency clearance request for the candidate vaccine with U.S. regulators shortly after obtaining enough safety data in late November. He expects manufacturing data to be ready for submission to these regulators by that date.
Pfizer reported quarterly profit exceeding estimates of one cent, helped by better-than-expected sales of its anti-cancer drug Ibrance.
Overall sales fell 4.3% in the third quarter, affected by a drop in sales of its unpatented pain reliever Lyrica and a $ 500 million impact on sales from the COVID-19 pandemic.
Sales of the cancer drug Ibrance rose 6% to $ 1.36 billion, beating analysts’ estimates of $ 1.39 billion, despite increased competition from Verzenio of Eli Lilly. Excluding items, Pfizer gained 72 cents per share, beating analysts’ estimates of 71 cents per share, according to IBES data from Refinitiv.
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