DRUGMAKER MODERNA TO ASK U.S., E-U REGULATORS TO APPROVE EMERGENCY USE OF COVID-19 VACCINE
Nov 30, 2020
By Bob Komsic
As new data confirms Moderna’s COVID-19 vaccine offers strong protection, the drugmaker plans to ask American and European regulators to allow emergency use.
Final analysis of its Phase 3 clinical trial shows it to be 94.1% effective.
A hearing will be held in the US. December 17 for possible approval; one week after the hearing for Pfizer’s vaccine candidate.
Moderna is one of several companies to have already submitted partial data to a rolling review process used by Health Canada; meaning drugmakers don’t have to apply or re-apply at every step.
Instead, they simply submit their newest data and findings.
If the U.S. Food and Drug Administration allows emergency use, the company expects to have 20-million doses ready for the U.S. by year’s end.
That would be enough for 10-million people as recipients will need two doses.
Moderna expects deliveries to Canada to start in the first three months of 2021.
One of the co-chairs of Canada’s COVID vaccine task force, Mark Lievonen, told Zoomer Radio’s ”Fight Back” with Libby Znaimer, if Health Canada approves, this country would be expected to receive six-million doses of Moderna and Pfizer’s vaccine in the first quarter of the new year.
”There will also be vaccines delivered, if all goes well, in second-quarter, the third-quarter, the fourth-quarter,” added Lievonen.
”They will continue to come.”
But Doug Ford says he’s still in the dark about when Ontario will receive vaccines and is calling on Ottawa for answer.
In the meantime, the premier’s calling the drug companies himself.
Ford adds he’s stilling waiting for the Trudeau government to answer three questions.