Moderna Inc. said that it has finished the application process for full approval of its COVID-19 vaccine in the United States, putting it on track to get the second such license from federal authorities.
Moderna seeks U.S. FDA full approval.
Moderna's COVID-19 Vaccine Would be the Second to Have Full Authorization if Application Will Be Approved
In a recently published article in CNN News, in the United States, the Moderna vaccine is presently accessible under emergency use authorization for individuals aged 18 and above. Moderna has also requested emergency use authorization from the FDA for its vaccination in individuals aged 12 and above.
Moderna's vaccine would be the second to get FDA approval. The FDA authorized the Pfizer/BioNTech vaccine for individuals aged 16 and up on Monday, potentially paving the way for additional vaccination requirements. If Moderna will pass the standard of the U.S. FDA, this will help to boost the vaccination mandate in the country.
However, even with priority review, the approval procedure may take months but the FDA shifted resources to speed up the clearance process for the Pfizer/BioNTech vaccine. Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Monday that the agency worked around the clock to perform its own studies and inspect facilities, just as it would for any other approval, according to MSN News.
Read Also: Moderna Considers to Include Children Aged 5-11 in the COVID-19 Vaccine Clinical Trials
Pfizer and Moderna Used the Same Technology, Approval of Full Authorization May Speed Up
To protect patients against COVID-19, both the Moderna and Pfizer vaccines utilize messenger RNA technology. According to statistics from the Centers for Disease Control and Prevention, the two injections have accounted for the overwhelming majority of vaccinations in the United States.
The FDA has used "sprint teams" to accelerate the process for COVID-19 vaccinations, despite the fact that a normal evaluation of a Biologics License Application may take up to eight months. The US Food and Drug Administration completed its assessment of the Pfizer-BioNTech vaccine in less than half the time it usually takes and the same may be applied to Moderna, according to a published report in Fortune.
A considerable quantity of safety, effectiveness, and manufacturing data will be evaluated by regulators. They will also have a look at Moderna's facilities. The U.S. Food and Drug Administration, however, could not be contacted for comment right away.
Government Hopes That Full Approval Will Help Encourage Americans to Be Vaccinated
In a recently published article in Bloomberg, the US government believes that a quick clearance would boost public trust in the vaccines and encourage those who have been reluctant to get vaccinated to do so. Approximately three out of every ten eligible people in the United States has yet to get a single dosage of any vaccination.
Companies, colleges, and state and municipal governments will find it simpler to impose vaccination requirements as a result of the ruling. Financial services and consulting companies have implemented additional vaccination requirements in the aftermath of the Pfizer-BioNTech vaccine clearance, and Delta Air Lines Inc. has announced a $200 monthly fee for workers who aren't immunized.
Related Article: US FDA Grants Full Approval to Pfizer's COVID-19 Vaccine, Recent Action Will Mandate Vaccination
