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Moderna to submit coronavirus vaccine to FDA for approval today, expects decision in December

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Igor Golovniov/SOPA Images/LightRocket via Getty Images

According to multiple reports, pharmaceutical company Moderna plans to submit its COVID-19 vaccine to the FDA for emergency approval Monday after fulfilling the required set of clinical trials and has announced that it has been told that the agency is meeting to discuss approval for the vaccine on Dec. 17, setting up the possibility that another form of the vaccine could be distributed before the end of 2020.

Moderna will become the second company to submit a vaccine to U.S. regulators for approval after Pfizer and BioNTech submitted their vaccine to the FDA for emergency approval on Nov. 20. According to Moderna, its vaccine has a 94% overall effectiveness rate, which is similar to the effectiveness rate for Pfizer's vaccine, according to clinical trials.

However, the makers of Moderna claim that their vaccine is 100% effective at preventing "severe" forms of the coronavirus. Moderna also claims that their vaccine is significantly easier to store than Pfizer's, which might make mass distribution of the vaccine easier.

If the FDA approves Moderna's application, it will be the first vaccine brought to market by the pharmaceutical company.

The company claims that no serious safety concerns were identified during the clinical trials and that side effects were mild and limited to "injection site pain, headaches and fatigue."

Moderna's vaccine will require two doses to be effective, and the company says that it has plans for 20 million doses — enough to inoculate 10 million people — by the end of 2020. The company's goal is to manufacture between 500 million and one billion doses in 2021.

Pfizer, meanwhile, has promised that it will have doses for up to 25 million people ready to ship by the end of the year, meaning that 35 million people in America could potentially receive the vaccine this year. It does seem clear, however, that the pharmaceutical companies will likely struggle to ramp up production in 2021 to an extent large enough to ensure that the global population is adequately served in 2021.

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