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Less than a year after the start of the unprecedented effort, the first COVID-19 vaccines are expected to reach Americans within weeks. No one knows for sure, but December 13 is the first possible day the vaccine could be given – although the following week is more likely. Here’s how we do it:

November 20

Pfizer and its German collaborator BioNTech have requested emergency use authorization for their COVID-19 vaccine from the Food and Drug Administration.

Moderna is expected to send in its vaccine request a week or two later, possibly on December 4.

An Emergency Use Clearance is an expedited vaccine clearance that can be processed much faster than the usual biologics license application, which results in FDA approval of a drug or vaccine.

Pfizer and BioNTech published the first results of the study indicating that their vaccine prevented more than 90% of infections with the virus that causes COVID-19.

Pfizer and BioNTech published the first results of the study indicating that their vaccine prevented more than 90% of infections with the virus that causes COVID-19.
Getty

The FDA is expected to take one to three weeks to review the request and make a decision on whether to issue the emergency clearance.

“It’s usually months, sometimes weeks,” said Dr Greg Poland, director of the Mayo Clinic’s vaccine research group.

Dec 10

Before the FDA issues a license or emergency use authorization, its policy is to have an external, independent committee known as the Advisory Committee on Vaccines and Related Biologics that reviews the application. VRBPAC holds public meetings where it discusses and then votes on whether to recommend the FDA to approve or authorize the vaccine.

Its recommendation is non-binding but is generally followed by the FDA.

A VRBPAC meeting to evaluate Pfizer’s vaccine candidate is scheduled for December 10.

Dr Moncef Slaoui, chief advisor to Operation Warp Speed, speaks in the Rose Garden of the White House, Friday, November 13, 2020, in Washington.

Dr Moncef Slaoui, chief advisor to Operation Warp Speed, speaks in the Rose Garden of the White House, Friday, November 13, 2020, in Washington.
Evan Vucci, AP

Dec 11

If VRBPAC votes on December 10, its decision would immediately rest with the FDA. At this point, FDA staff would make a final decision.

Although it will probably take a few days, In theory, Friday, December 11, would be the earliest date the FDA could clear the vaccine, but the week of December 14 is considered more likely.

General Gustave Perna, COO of Operation Warp Speed, has repeatedly stated that vaccine distribution will begin within 24 hours of FDA clearance. The vaccine will be shipped to all 50 states that day, broken down by population.

Once a vaccine is cleared, Operation Warp speed could begin shipping the vaccine to distribution centers. However, it cannot be given to health care providers until another committee has made a decision.

Dec 12

The final vote will come from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. ACIP makes the official decision on who should be vaccinated and in what order.

In October, the National Academies of Science, Engineering and Medicine presented an equitable distribution plan which is used as a framework by the CDC committee, but ACIP has the final say.

ACIP is not authorized to make a recommendation until a vaccine has been authorized or approved. Typically, this would happen within weeks of FDA action. But in this case, several members suggested that such a meeting could take place the day after the vaccine was released.

The first such meeting could take place on December 12. Once it votes, ACIP submits a decision note to the CDC Director for approval. Once approved, vaccinations can begin.

Dec 13

This means Sunday December 13 would likely be the first date the COVID-19 vaccine could be administered across the United States, although the week of December 14 is more likely. The initial doses will go to frontline healthcare workers such as doctors, nurses and paramedics.

The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland, Baltimore School of Medicine receives an injection on May 4.

The first patient enrolled in Pfizer’s COVID-19 vaccine clinical trial at the University of Maryland, Baltimore School of Medicine receives an injection on May 4.
AP

Dec 31

By the end of December, Perna said Operation Warp Speed ​​expects around 40 million doses of both vaccines to be available for distribution. Both Pfizer and Moderna vaccines require two doses administered between 21 and 28 days apart. Thus, 40 million doses would suffice to immunize approximately 20 million people.

“This is perhaps the most ambitious immunization program the United States has ever implemented,” said John Grabenstein, managing director of Vaccine Dynamics and editor of the Immunization Action Coalition, a nonprofit information on vaccines.

“The 1976 influenza vaccination program reached about 70 million people. The poliovirus vaccine was quickly distributed in 1955. The United States has more people now than it did then, but the scale of this coronavirus vaccination program is impressive, ”he said.

Other vaccines will be rolled out in 2021 and distributed in stages, prioritizing those at risk of infection or serious illness. The healthy American population should have access to it starting in April, according to Dr.Anthony Fauci, the nation’s leading infectious disease specialist.

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