The approval is the first in the world for Moderna’s vaccine, which is similar to the two-dose Pfizer-BioNTech shot that was given the green light in the U.S. and several other countries last week.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn in a statement.
The pandemic continues to exert a terrible toll on the U.S., which has been posting alarmingly high numbers of infections, deaths and hospitalizations every day since November.
Wednesday saw another new record of 3,668 deaths and 247,403 new cases, according to Johns Hopkins University. As of Friday, the COVID Tracking Project says 114,751 Americans are in hospital with COVID-19 — also a new record.
A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before holiday gatherings that are certain to further fuel the outbreak.
The Moderna vaccine is seen as easier to ship to remote and rural communities compared to Pfizer’s vaccine, which needs to be stored at extremely low temperatures that require specially-made freezers.
Until now, it was believed the vaccine had to remain frozen to at least -20 C until shortly before use, but the company said Friday it can now safely transport liquid doses as refrigerated at between 2 C and 8 C.
Moderna expects to have between 100 million and 125 million doses available globally in the first three months of 2021, with 85-100 million of those available in the U.S.
Even with additional candidates in the pipeline, there won’t be enough for the general population until spring, and shots will be rationed in the meantime. And while health workers are enthusiastically embracing vaccination, authorities worry the public may need more reassurance to ensure more people get in line when it’s their turn.
Moderna has about 5.9 million doses ready for shipment set to begin over the weekend, according to Operation Warp Speed, the U.S. government’s vaccine development program. Injections of health workers and nursing home residents continue next week, before other essential workers and vulnerable groups are allowed to get in line.
Both Moderna’s and Pfizer-BioNTech’s shots are so-called mRNA vaccines, made with a groundbreaking new technology. They don’t contain any coronavirus — meaning they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing comes along.
In a statement after the FDA announced its approval, Health Canada said its review team is still waiting for final data on Moderna’s manufacturing process before making its own decision.
“Health Canada cannot provide a definite timeline for the completion of the review at this time, although it is expected to be completed in the coming weeks,” the statement reads.
Canada’s territories, Indigenous communities and long-term care homes are awaiting approval of the Moderna vaccine due to its easier shipping and storage capabilities.
None of the initial shipment of 30,000 Pfizer-BioNTech vaccine doses have been sent to distribution centres in Canada’s territories due to the difficulty in transporting that vaccine.
Canada has signed a deal with Moderna for at least 40 million doses of its vaccine, with that order potentially climbing to 56 million. Nearly 170,000 doses are expected to arrive once Health Canada gives the green light, which officials have said would likely happen before the end of the year.
–With files from the Associated PressView link »