FDA greenlights Moderna’s COVID-19 vaccine

December 19, 2020 04:22 PM AEDT | By Hina Chowdhary
 FDA greenlights Moderna’s COVID-19 vaccine

Summary

  • Moderna's COVID-19 vaccine has secured the emergency use authorisation (EUA) in the US.
  • The US regulatory body had issued the EUA to Pfizer's COVID-19 vaccine a week before.

For a world striving to emerge out of COVID-19 gloom, the light at the end of the tunnel just got brighter. Adding to the hope for the future, another vaccine to prevent the coronavirus has got the green light to hit the sales counters.

Just a week after approving Pfizer-BioNTech’s COVID-19 vaccine, the US Food and Drug Administration (FDA) has now issued an emergency use authorisation (EUA) for Moderna’s COVID-19 vaccine. This clears the way for distribution of the vaccine in the US, for use in individuals aged 18 years and above. 

Moderna has become the second US pharma company to secure approval for its COVID-19 vaccine. Earlier, on 11 December 2020, the FDA issued the first EUA to Pfizer-BioNTech COVID-19 vaccine.

Must read: Pfizer's COVID-19 vaccine receives a go-ahead sign from FDA Expert Panel

Moderna is set to deliver the vaccine to the US government on an immediate basis. A Biologics License Application (BLA) with the FDA for a full licensure is expected to be submitted next year.

Vaccine Details

The vaccine by biotechnology company Moderna, Inc. (Nasdaq:MRNA) contains mRNA, a genetic material. The vaccine is administrated in two doses in one-month gap.

When injected into a person, the vaccine infuses a tiny part of the SARS-CoV-2 virus' mRNA into the body, triggering the production of virus' peculiar "spike" protein. Once a person gets the vaccine dose, the body starts replicating the spike protein in large numbers, which as per the FDA, does not cause the disease but elicits an immune response against SARS-CoV-2.   

Image Source: Shutterstock

Also read: Moderna's COVID-19 vaccine impresses, demonstrates 94.5% efficacy

The FDA has assured that the vaccine has met the required conditions. For the vaccine development process, the agency conducted a proper evaluation in terms of effectiveness, safety, and manufacturing quality information. The available research data shows that the vaccine may be beneficial in limiting the viral infection.

The Reported Side Effects: The commonly reported side effects are headache, tiredness, pain at the injection site, chills, muscle pain and swollen lymph nodes in the arm where one receives the injection, joint pain, vomiting, nausea, and fever. These side effects last for several days and are mostly experienced after the second dose.

Also Read: Premiers Demand Funding Boost From Trudeau-Led Govt Amid Surging COVID Cases


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