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December 21, 2020

FDA Authorizes Emergency Use of Moderna’s COVID-19 Vaccine

FDA Authorizes Emergency Use of Moderna’s COVID-19 Vaccine

Updated on December 20, 2020 at 1:42pm EST.

A second COVID-19 vaccine is now available in the United States, offering millions more Americans an opportunity to receive protection against the disease that has upended lives around the world for nearly one year.  

The COVID-19 mRNA vaccine, known as mRNA-1273, which was developed by Moderna has been approved by the U.S. Centers for Disease Control and Prevention (CDC). CDC Director, Robert Redfield, MD, accepted the recommendation of the agency’s Advisory Committee on Immunization Practices (ACIP) that the vaccine may be given to people ages 18 and older. This was the final hurdle that needed to be cleared before the vaccine could be given to people in the United States.

In clinical trials, Moderna's two-dose coronavirus vaccine was shown to be 94.1 percent effective against COVID-19 and 100 percent effective against severe COVID-19.

The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) of Moderna's vaccine on Friday, December 18. It’s the second vaccine to receive a green light for use in the United States. Just a week ago, the FDA granted EUA to the COVID-19 vaccine developed by Pfizer and the German drugmaker, BioNTech. 

During a public health crisis, like the pandemic, the FDA has the power to issue an EUA. It’s a way to allow the immediate use of a vaccine or therapy before it’s formally approved as long as certain criteria about its safety and effectiveness have been met.

As with the emergency authorization of Pfizer’s vaccine, the FDA’s decision came on the heels of a meeting of the Vaccines and Related Biological Products Advisory Committee—an independent group of experts that advised the agency to grant an EUA of Moderna’s experimental vaccine.  The committee includes independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative. 

The EUA enabled the vaccine to begin shipping immediately, adding to the millions of doses already shipped by Pfizer and BioNTech. But people couldn't start receiving the shot until it was recommened by the ACIP and approved by the CDC. The agency recommended that healthcare workers and long-term care facility residents be first in line for the vaccine.

What happens now?
The EUA of Moderna’s vaccine allows shipping to begin but Americans can’t start receiving the shot until two more hurdles are cleared: The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices must recommend the vaccine and the CDC must accept the committee’s recommendation.

Moderna is already working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and vaccine distributor, McKesson, to prepare to distribute its vaccine around the world. 

On December 11, the Department of Health and Human Services announced that the U.S. government purchased an additional 100 million doses of Moderna’s vaccine, bringing the U.S. total to 200 million doses. The additional doses will help ensure continuous delivery through the end of June 2021.

By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the United States. Moderna also plans to make up to one billion doses globally in 2021.

What human trials have shown
Moderna announced the first set of complete results from their ongoing coronavirus vaccine trial in November.

For the Phase 3 trial, 15,000 volunteers were given a placebo, or a shot of saline. Another 15,000 volunteers received the experimental vaccine. Of these people, 37 percent were from racial and ethnic minority groups, which is similar to the diversity of the overall U.S. population.

High-risk groups also account for 42 percent of the participants, including more than 7,000 people older than 65, more than 5,000 people who are younger than 65 but have chronic diseases that put them at higher risk of severe COVID-19, such as diabetes, severe obesity and heart disease.

An FDA data review released on December 16 confirmed that the vaccine is highly successful with an efficacy rate of 94.1 percent. The review also concluded that the vaccine was safe and well-tolerated among the participants.

The most commonly reported side effects include pain at the injection site, fatigue, headache, muscle or joint pain and chills. These issues were temporary and not serious, the agency found.

Ongoing safety monitoring
In October 2020, the FDA said that to receive an EUA, companies must submit at least two months of follow-up data. Because side effects associated with vaccination usually crop up within six weeks of vaccination, the two-month requirement was considered long enough to identify short-term adverse events related to the vaccine. 

When submitting an experimental vaccine to the FDA for EUA, drug companies must outline a plan for active follow-up to monitor the long-term safety of their vaccine. This includes keeping track of any adverse events, such as hospitalizations, and other serious reactions. This follow-up data is needed for the ongoing support of an EUA.

Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by the FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist.

More about the vaccine
Both the Pfizer and Moderna vaccines are mRNA vaccines—a newer type of vaccine technology.

They work by delivering instructions (mRNA) to muscle cells to make the COVID-19 spike protein—the protein that the coronavirus (SARS-CoV-2) uses to infect cells. This protein triggers an immune response in the body without causing the disease. Once the protein is made, your cells break it down and get rid of it.

Keep in mind, mRNA won’t change your DNA. It never actually enters the nucleus of cells where your DNA is located. And although these vaccines are new, other mRNA vaccine technology has been in development for decades for viruses, like flu and Zika.

Cancer researchers have even used mRNA to target specific cancer cells.

One key difference between Pfizer and Moderna
Unlike the Pfizer vaccine, Moderna’s vaccine remains stable for 30 days at 36° to 46°F—the temperature of a standard home or medical refrigerator.

At a colder temperature of -4°F, it could remain stable for up to six months, while it may last for 12 hours at room temperature.

Most pharmaceutical distribution companies have the ability to store and ship products globally at -4°F. 

Pfizer’s experimental vaccine, on the other hand, must be stored in an ultra or deep freezer at about -94° F to remain effective.

The company noted this potential barrier to its distribution but says it has developed specially designed, temperature-controlled thermal shippers that use dry ice to maintain the necessary ultra-low temperatures.

These shipping units can be used as temporary storage of the vaccine for up to 15 days if they are refilled with dry ice. Each unit is equipped with a heat sensor to track its location and temperature during shipment.

Dry ice is made by compressing and cooling liquid carbon dioxide, but liquid carbon dioxide is currently in short supply, according to the American Chemical Society.

Medically reviewed in December 2020.

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American Chemical Society. “Short CO₂ supply may complicate COVID-19 vaccine rollout.” Nov 19, 2020.