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November 30, 2020

Moderna seeking FDA authorization for its COVID-19 vaccine

New data confirms the vaccine's high efficacy rate

Prevention Vaccines
Moderna FDA vaccine Pavlo Gonchar/SOPA Images/Sipa USA

Moderna's COVID-19 vaccine has been found to be effective across all age, racial, ethnic and gender demographics.

Moderna will become the second pharmaceutical company to submit a COVID-19 vaccine to the U.S. Food and Drug Administration when it files for emergency use authorization Monday. 

The vaccine was found to have an efficacy rate of 94.1% in a late-stage clinical trial that enrolled more than 30,000 U.S. participants. The vaccine’s effectiveness was found to be consistent across all age, racial, ethnic and gender demographics.

Those findings, released Monday, are detailed in a primary efficacy analysis that confirms the high efficacy indicated by preliminary results.

Of the 196 study participants who contracted COVID-19, only 11 received the vaccine. The others received a placebo. 

Thirty people developed severe cases of the virus – all in the placebo group, indicating the vaccine was 100% effective at preventing severe cases. One study participant who received the placebo died of COVID-19.  

"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," Moderna CEO Stéphane Bancel said. 

No serious safety concerns have been identified. The most common side effects of the vaccine are injection site pain, fatigue, muscle pain, joint pain, headaches and redness at the injection site.

The tolerance of the vaccine is still being reviewed and monitored by an independent Data Safety Monitoring Board.

The FDA could authorize Moderna's vaccine as early as Dec. 17. That's when the FDA's Vaccines and Related Biological Products Advisory Committee will meet to discuss the safety and efficacy data. 

Moderna is poised to begin distribution across the U.S. shortly after it receives authorization. The biotechnology company expects to have about 20 million doses available in the U.S. by the end of year. The company is on track to produce 500 million to 1 billion doses globally in 2021.

Moderna is making similar authorization requests with other global health and safety regulators.

The vaccine uses messenger RNA technology to strengthen the immune system's response to the coronavirus. It can be stored at regular refrigerator temperatures, either for a month at 35 to 46 degrees Fahrenheit or for up to six months at -4 degrees.

Pfizer submitted an emergency use authorization for its COVID-19 vaccine earlier this month. Late-stage clinical trials have found Pfizer’s vaccine candidate to be 95% effective against COVID-19.

AstraZeneca has said that it is preparing to submit data to regulators for an emergency use authorization of its vaccine candidate. Clinical trials have shown that its vaccine is up to 90% effective.

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