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Moderna Concludes FDA Submission For Its COVID-19 Shot In Adolescents, Kids

By Vandana Singh
  • Reuters reported that Moderna Inc (NASDAQ:MRNA) had made required submissions to the FDA for emergency use authorization of its COVID-19 vaccine in adolescents and children.
  • An advisory panel of experts to the U.S. drug regulator will meet in June to review the request.
  • Related: FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA.
  • The company is seeking approval for its vaccines in adolescents aged 12 to 17 years, children aged six to 11, and those between six years and six months. 
  • The company said the submissions for all three groups were made on May 9.
  • Although the FDA approves Moderna's vaccine for use in adults 18 years and older, its use in the younger age groups has hit a roadblock as the agency asked for more safety data.
  • Australia, Canada, and the European Union have approved the vaccine for use in six- to 17-year-olds.
  • In April, the company sought U.S. authorization for its COVID shot in children under six years
  • Price Action: MRNA shares are up 4.76% at $129.30 during the market session on the last check Thursday.
  • Photo by Spencer Davis from Pixabay
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Dive Deeper:
TGA evaluates baby COVID-19 vaccine
Australian regulators are investigating whether a low dose of Moderna’s COVID-19 vaccine can be given to children aged from six-months…
Probe to check Covid deaths of vaccinated
Public Health Minister Anutin Charnvirakul has agreed to launch an investigation to find out why so many people have died…
Why Veru Shares Are Soaring Today Premarket
In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients.…
Eli Lilly's Olumiant Becomes First FDA Approved Immunomodulatory Treatment For COVID-19
The FDA approved Eli Lilly And Co's (NYSE:LLY) Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane…
One subscription that gives you access to news from hundreds of sites
FDA Approves Lilly and Incyte's OLUMIANT (baricitinib) for Hospitalized Patients with COVID-19
The U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized patients.
The Daily Biotech Pulse: FDA Orphan Drug Tags For Neurocrine, Editas Candidates; Sale of BridgeBio's PRV; RMAT Designation For PolarityTE's Product
Here's a roundup of top developments in the biotech space over the last 24 hours:
Get all your news in one place