Moderna concludes USFDA submission for use of COVID vaccine in adolescents, kids
New Delhi: Moderna Inc has made all necessary submissions required by the U.S. Food & Drug Administration for emergency use authorization of its COVID-19 vaccine in adolescents and children, it said on Wednesday.
The company is seeking approval for the use of its vaccines in three distinct age groups - adolescents aged 12 to 17 years, children aged six to 11 and those between six years and six months. The submissions for all three groups were made on May 9, it said.
Although Moderna's vaccine is approved by the FDA for use in adults 18 years and older, its use in other age groups has hit a roadblock as U.S. regulators have sought more safety data.
Australia, Canada and the European Union though have approved the vaccine for use in six- to 17-year olds.
The company sought U.S. authorization of its COVID shot in children under the age of 6 in April.
An advisory panel of experts to the U.S. drug regulator will meet in June to review the request.
Read also: Moderna seeks USFDA emergency use nod for COVID vaccine in children younger than 6
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.