US Biotechnology Company Moderna Receives FDA 'Fast Track' Designation For COVID-19 Vaccine

The “fast track” designation grants eligibility to a vaccine or treatment for the US Food and Drug Administration's (FDA) “priority review” status, under which the agency aims to decide on approving the drug within six months

India   |   14 May 2020 9:54 AM GMT
Writer : Sanjukta Mandal | Editor : Shubhendu Deshmukh | Creatives : Nandan M
US Biotechnology Company Moderna Receives FDA Fast Track Designation For COVID-19 Vaccine

The US Food and Drug Administration (FDA) gave "fast track" designation to an American Biotechnology Company Moderna Therapeutics' experimental coronavirus vaccine mRNA-1273. On Tuesday, May 12, the California based biopharmaceutical firm announced that they got a nod from FDA to go ahead with mRNA vaccine, that is designed to fight against the COVID-19.

The "fast track" designation grants eligibility to a vaccine or treatment for the agency's "priority review" status, under which the FDA aims to decide on approving the drug within six months. Moderna will conduct phase II trial of the vaccine shortly and is expected to begin phase III in summer 2020. The vaccine may get marketing approval in 2021. The trial will focus on safety, reactogenicity and immunogenicity in two doses at an interval of 28 days.

"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus," said Tal Zaks, MD, Ph.D., Chief Medical Officer at Moderna.

"As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2," the officer added.

The COVID-19 preventive vaccine mRNA-1273 uses a new technology based on messenger RNA (mRNA) of the virus. In a bid to construct viral protein or antigen, researchers inject the messenger RNA. The injected antigen will evoke the immune system to create antibodies to recognize the 'spike protein' - the major surface of protein the virus uses to infect human cells. It can thus help the body fight COVID-19.

The novel coronavirus has claimed over 2,96,000 lives in the world so far, infecting 4.34 million. With no antidote being ready to curb the spread of COVID-19, health researchers and scientists across the globe are traversing different ways to find out a cure to the virus.

Over 100 potential COVID-19 vaccines are being developed across the world. However, the World Health Organisation has notified that it may take at least 12 months to develop a vaccine.

Also Read: Fact Check: Fake List Of Advice To Live With COVID-19 Attributed To ICMR, Dr Devi Shetty

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