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Moderna Applies For Full Approval Of Its COVID Vaccine In US

Pharmaceutical giant Moderna Inc., on June 1, filed for approval of its vaccine for the full US Population. As of now, only Pfizer Inc. has sought approval.

Moderna

Image: AP


Pharmaceutical giant Moderna Inc., on June 1, filed for full approval of its vaccine, an expansion from current Emergency Use Approval.  As of now, only Pfizer Inc. along with its partner BioNTech have applied for full clear for their vaccine candidate. This comes as the Food and Drug Administration (FDA), earlier this month, gave a go-ahead to inoculation of children between 12- 15 years with Pfizer/BioNTech jabs.

Based on trials

The FDA approval is based on trial data for a minimum of six months. On Tuesday, Moderna said that it will continue to submit data to the FDA on a rolling basis over the coming weeks, with a request for a priority review. On completion of the submission, the agency will notify the company when it is formally accepted for review.

The Massachusetts based Moderna’s vaccine is approved in over 40 countries around the world. Additionally, it has inked a pact with the Biden administration to supply 300 doses of its vaccines to American vaccination centres. The based coronavirus vaccine, when injected into the upper arm sends the mRNA into the bloodstream. The virus makes copies of itself by entering into the healthy host cells using protein spike structures that are made out of RNA and DNA. The mRNA from the vaccine contains the synthetic version of the RNA that tricks the immune system that the virus is present, thereby accelerating the anti-body-making process. 

Last week,  Moderna claimed that its COVID-19 vaccine strongly protects kids as young as 12-years-old-- a step that could put the shot on track to become the second option for that age group. The company studied more than 3,700 persons aged between 12 to 17 years. Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects were observed such as sore arms, headache and fatigue. There were no COVID-19 diagnoses in those given two doses of the Moderna vaccine compared with four cases among kids given dummy shots.

Image: AP

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