⁍ Pfizer said in a presentation that the independent monitor which will determine whether or not the trial has been successful has not conducted any interim efficacy analyses yet.
⁍ Pfizer and BioNTech launched their 44,000 volunteer phase 3 study of their vaccine in late July.
⁍ Pfizer reported quarterly earnings that beat estimates by one cent, helped by lower-than-expected costs.
– It looks like Pfizer’s Pandemic Pandemic vaccine may not be ready for prime time. The company said Tuesday that it’s not yet ready to release data from its late-stage trial of the vaccine, which is being developed with Germany’s BioNTech, Reuters reports. The independent monitor that will determine whether the trial is a success has not conducted any interim efficacy analyses yet. If the trial is successful, Pfizer will file for emergency authorization from US regulators in late November, and it expects to have manufacturing data ready to submit to those regulators before then. The company also said that if the trial is successful, it still expects to file for emergency authorization of the vaccine candidate from US regulators shortly after it has enough safety data in late November. Pfizer reported quarterly earnings that beat analysts’ estimates by one cent, helped by lower-than-expected costs. Sales fell 4.3% to $12.13 billion in the third quarter due to a sharp drop in revenue from its off-patent pain drug Lyrica, as well as a $500 million hit from the COVID-19 pandemic. Excluding items, Pfizer earned 72 cents per share, beating analysts’ estimates of 71 cents per share, according to IBES data from Refinitiv. As the pandemic crimps demand for certain Pfizer therapies and damages global economies, investors are keenly focused on seeing the late-stage study data of the vaccine candidate being developed with BioNTech. Healthcare investor Brad Loncar said it was difficult to draw a positive or negative conclusion from the fact that the trial has not yet had its first interim analysis. “I think this means that the overall infection rate is a lot lower than Pfizer initially estimated,” Loncar said.
Source: https://www.reuters.com/article/us-pfizer-results/pfizer-not-yet-ready-to-release-covid-19-vaccine-data-idUSKBN27C1GT