NVAX Stock – Talk To Us: COVID QUESTIONS
BPR is answering listener queries about the Coronavirus in our weekly segment –Talk to Us: COVID Questions. BPR’s Helen Chickering brings us this week’s answer.
This week’s COVID question is from Christine Westfeldt of Fairview.
“Do you have any information on the Novavax vaccine? They have an extensive website and description of their vaccine and vaccine trials that I have not heard mentioned in your reporting. And I’m very interested in when it will be available in the U.S.”
Good Question, to find out we asked Cindy Gay, MD, MPH, an Associate Professor in the Division of Infectious Diseases at the University of North Carolina, which is a Novavax trial site. Dr. Gay is the site principal investigator and vaccine study co-chair.
“Your listener is right, there is an ongoing Novavax Phase-3 study in the United States and some sites in
Mexico,” says Dr. Gay. “We completed enrolling on the study on February 16th, so all of the participants are being followed at the moment. The protocol and study team are sort of cleaning the data, getting prepared and collating all the data from the sites to be able to put together to submit to the FDA for EUA approval.”
“The exact date of when that would be is not yet clear, says Gay, “but we are anticipating that it would be, likely in the next month or two, that the submission would be going in”
“There is published data on the same vaccine from a Phase-3 study in the UK where the efficacy was 96% with the ancestral strain and 86% effective against the UK variant. And also a Phase-2B study in South Africa, which also showed efficacy, including against the South African 351 variant.”
“Notably, the study is also opening up to adolescents, ages 12 to 17 and that should start opening up later this week, says Gay. “It’s the same design, placebo blinded study again to get more vaccines approved and accessible to adolescents.”