Data for the late stage trial of its vaccine candidate against Covid-19 is not yet ready to be published, said drug maker Pfizer Inc on Tuesday. The company is developing the vaccine in partnership with Germany’s BioNTech SE.
Any interim efficacy analyses had not yet been conducted by the independent monitor that is tasked with determining whether or not the trial has been successful, Pfizer said in a presentation.
The company was scheduled to release data on whether the vaccine candidate actually works as early as this month according to an announcement made previously by its Chief Executive Albert Bourla.
During the election campaigns, United States president Donald Trump had said that news about a successful vaccine against Covid-19 would be available prior to the presidential election date of November 3. However in recent week, the Trump administration has instead emphasized that a vaccine is likely to be available by this year.
Successful data from a late-stage Covid-19 vaccine trial is expected to be unveiled by Pfizer which will make it the first US drug maker to be able to be able to come out with a vaccine by beating rival Moderna Inc.
The 44,000 volunteer phase 3 study of their vaccine candidate was launched by Pfizer and BioNTech in late July.
The data monitoring board is scheduled to make its first assessment of the vaccine’s performance after 32 participants in the trial become infected with the novel coronavirus.
Of the fact that the trial has not yet had its first interim analysis, therefore drawing a positive or negative conclusion based on the trials is difficult, said healthcare investor Brad Loncar.
“I think this means that the overall infection rate is a lot lower than Pfizer initially estimated,” Loncar said. “So the trial is just running a little slower than they thought.”
Investors of Pfizer are eagerly waiting to see the results of the late-stage study data of the vaccine candidate being developed with BioNTech even as the novel coronavirus pandemic has brought down demand for the drug maker’s \certain therapies and with global economies being hammered severely.
The company still expects to file for emergency authorization of the vaccine candidate from US regulators as soon as it is bale to gather enough safety data in late November if the trial is successful, the company also said. And before that date, the company also expects to have enough manufacturing data ready for submission to those regulators.
Helped by better-than-expected sales of its cancer drug Ibrance, Pfizer reported quarterly earnings that beat estimates by one cent.
Because of a plunge in sales of its off-patent pain drug Lyricaas well asa pandemic induced hit to its sales worth $500 million, a 4.3 per cent drop in its overall sales in the third quarter was reported by the company.
Despite increased competition from Eli Lilly’s Verzenio, the company reported a grwoht of 6 per cent in the sales of cancer drug Ibrance at $1.36 billion which beat analyst estimates of $1.39 billion sale revenues.
(Adapted from NDTV.com)