Moderna to Seek Emergency Authorization for COVID-19 Vaccine, Claims 100% Efficacy Against Severe Infection

Moderna's COVID-19 vaccine continued to show promising results as it yielded 94% efficacy and will move forward with an emergency approval request to the Food and Drug Administration (FDA) on Monday.

The Massachusetts-based company said it will seek immediate commercial marketing clearance from the European Medicines Agency as well, reported Stat News.

Moderna CEO Stéphane Bancel said in an interview with "Mornings with Maria" on Fox Business that the FDA will likely consider the COVID-19 vaccine at a meeting on December 17.

If Moderna gets approval from the FDA, it may join the Pfizer and BioNTech COVID-19 vaccine as the two earliest vaccines in the race to a safe and effective inoculation.

Pfizer reported positive results in its own vaccine trials on November 18 and requested for emergency authorization from the FDA after two days.

"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," said Bancel in a statement.

He also thanked the volunteers in their vaccine studies and partners at the National Institutes of Health, the U.S. Biomedical Advanced Research and Development Authority and Operation Warp Speed, the government's vaccine initiative.

Moderna Vaccine Was 100% Effective Against Severe COVID

Moderna's vaccine is composed of two doses which recorded 94.1% efficacy against the virus based on a total of 196 cases of symptomatic COVID-19.

Only 11 of those symptomatic patients received vaccine doses, the remaining 185 volunteers were from the placebo group.

Impressively, the vaccine also showed no cases of severe COVID-19 from its trial group.

No severe cases of the disease occurred in the patients who received a vaccine but there were 30 severe cases found in the placebo group, reported Science Magazine.

According to Natalie Dean, a statistican from the University of Florida, the existing data "bolster" strong results that were released by Moderna.

Dean noted that since the vaccine was showing impressive results in both mild and severe cases, it "checks a lot of boxes" for approval.

On November 16, Moderna showed that during the early stages of the study, it was about 94.5% effective at preventing COVID-19 infection.

During that early analysis, the company found 95 cases of symptomatic infection with 90 of them from the placebo group.

So far, the trials did not show any severe safety concerns.

At most, the adverse effects of the medication were site pain, fatigue, muscle or bone pain, headaches and redness of injection site.

Moderna Wants Immediate Vaccination After FDA Approval

Bancel said that the company wants to ensure immediate distribution 24 hours after the FDA gives them the go signal.

"I believe in the first quarter [of 2021] most people that want a vaccine, that are at higher risk with older age, severe disease, health care worker, frontline worker, should be able to get vaccinated," he said.

Following those groups of people, Bancel believes Americans older than 18 years old have to be vaccinated next.

Moderna will also try to start a clinical study in the next week to see if the vaccine is safe and can prevent infection among teenagers.

"I hope to have that data by the end of the spring ... so they can go back to school next September," he said.

It's still unknown for how long the Moderna vaccine can provide protection against the coronavirus.