Moderna asks FDA approval for emergency use of its COVID-19 vaccine [Video]

WHAT YOU NEED TO KNOW:

• Moderna announced on Monday that it would submit its developed vaccine for COVID-19 to the Food and Drug Administration (FDA) for regulatory approval.
• Based on its phase 3 trial results, the vaccine was 100 percent effective at preventing serious illness from COVID-19.
• The US federal government has provided Moderna with over $2.5 billion to fund the vaccine development and to supply the citizens nationwide.

On Monday, Moderna Inc. is set to submit its COVID-19 vaccine for Food and Drug Administration’s (FDA) regulatory.

After Phase 3 trial results showed a 94.1 percent efficacy, the biotech company announced that it would ask the FDA to authorize the emergency use of its vaccine.

In addition, the company said that its vaccine was completely effective (100 percent) at preventing severe cases of COVID-19. The result was consistent in all categories ━ age, race, and gender.

So far, the vaccine showed no serious concerns with regard to safety as the typical side effects include headaches, muscle and joint pain, and feeling fatigued.

On December 17, Moderna said that it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to meet and assess its vaccine proposal. A week before that, the agency is also anticipated to convene on the vaccine developed by Pfizer and German partner BioNTech. They were the first drugmakers who applied for regulatory approval, with their vaccine’s efficacy is also above 90 percent.

Both vaccine developers made a similar approach of incorporating a special code called mRNA. It is inserted into the body to develop an immune response. Should both vaccines be granted for use, it would be the first mRNA-based drug that would be approved.

Professor Hajo Zeeb from Germany’s Leibniz Institute for Prevention Research and Epidemiology said that it was inspiring that both developers yield the same high success percentage.

“I would be surprised if something different came out in the FDA process, and I think these are highly likely to be approved,” he said.

Zeeb, however, cautioned that the success rates could change once the vaccine would be administered to hundreds of millions, as it was tested in tens of thousands.

“These are still small numbers overall…  but the reduction in severe cases is exactly what we want to see. If it’s just a mild virus, we can live with that,” he said, citing the trial’s sampling figures.

With a trial sample size of 30,000, half of the population were administered with the vaccine while the other half took a placebo. The researchers recorded 196 COVID-19 cases, only of whom came from the group that was given the vaccine. There were 30 severe cases, all of which belonged to the placebo group.

Moderna said that from the 15,000 people who received the vaccine, not even one showed serious signs of illness from COVID-19 in the trial stage.

The US federal government provided a total of more than $2.5 billion funding to Moderna, where over $1 billion is used to develop the vaccine and the remaining would be allocated to supply the Americans.

Source: AOL.com