Less than a year after the unprecedented effort began, the first COVID-19 vaccines are expected to reach Americans within weeks. No one knows for certain, but Dec. 13 is the first possible day the vaccine could be administered – although the week after is more likely. Here's how we get there:
Pfizer and its German collaborator BioNTech applied for emergency use authorization for their COVID-19 vaccine from the Food and Drug Administration.
Moderna is expected to send in its application for its vaccine one to two weeks later, perhaps by Dec. 4.
An emergency use authorization is a fast track vaccine authorization that can be processed much more quickly than the usual Biologics License Application, which results in FDA licensing a drug or vaccine.
The FDA is expected to take one to three weeks to go through the application and make a decision on issuing the emergency authorization.
"It's typically months, occasionally weeks," said Dr. Greg Poland, director of the Mayo Clinic's Vaccine Research Group.
Before the FDA issues a license or an emergency use authorization, its policy is to have an external, independent committee known as the Vaccines and Related Biological Products Advisory Committee review the application. VRBPAC holds public meetings during which it discusses and then votes on whether to recommend the FDA approve or authorize the vaccine.
Its recommendation is nonbinding but is usually followed by the FDA.
A VRBPAC meeting to evaluate Pfizer's candidate vaccine has been scheduled for Dec. 10.
Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, speaks in the Rose Garden of the White House, Friday, Nov. 13, 2020, in Washington.
EVAN VUCCI, AP
If VRBPAC votes on Dec. 10, its decision would immediately go to the FDA. At that point, FDA staff would make a final determination.
While this will likely take a few days, theoretically, Friday, Dec. 11, would be the earliest date FDA could authorize the vaccine but the week of Dec. 14 is considered more likely.
General Gustave Perna, Chief Operating Officer of Operation Warp Speed, has said on multiple occasions that vaccine distribution will begin within 24 hours after an authorization is issued by FDA. Vaccine will be shipped to all 50 states that day, allocated by population.
Once a vaccine is authorized, Operation Warp speed could begin shipping vaccine to distribution centers. However it can't be given to health care providers until one more committee makes a decision.