Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • USFDA authorizes up to...

USFDA authorizes up to 15 doses per vial of Moderna COVID-19 vaccine

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-04-03T11:30:12+05:30  |  Updated On 5 April 2021 2:47 PM IST
USFDA authorizes up to 15 doses per vial of Moderna COVID-19 vaccine
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

Cambridge: Pharma major, Moderna, has recently announced that based on submitted stability data, the U.S. Food and Drug Administration (FDA) has authorized the Moderna COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours.

Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours. These new guidelines are reflected in an updated Emergency Use Authorization (EUA) label. The Moderna COVID-19 Vaccine is ready for use and does not need to be diluted.

The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, from the previously authorized 10 doses per vial. The Moderna COVID-19 Vaccine now can be supplied in two vial presentations (a multiple-dose vial containing a maximum of 11 doses or a multiple-dose vial containing a maximum of 15 doses). The Company expects that the 15-dose vials will begin shipping in the coming weeks.

"We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs. Thank you to the U.S. FDA and CDC for their ongoing collaboration," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain focused on doing all that we can to help end the COVID-19 pandemic with a vaccine."

Moderna is continually learning, adapting and working closely with its partners and the U.S.government to identify ways to facilitate accelerated vaccine administration, address bottlenecks and accelerate production. One identified constraint on the production process has been the capacity of the fill-and-finish process. Moderna studied the possibility of adding more doses to each vial of vaccine to address bottlenecks, accelerate production and reduce the need for consumable materials that are in high demand. Moderna will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without compromising quality or safety.

Read also: Additional Four million doses of Moderna COVID-19 Vaccine purchased by Canada



modernamoderna newscoronavirus vaccinecovid-19coronavirususfda
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story

    Editorial

    Featured image representing orthopaedic care

    Modern Orthopaedic Care: How Is Technology Improving Movement and Recovery? - Dr Abhijit Lonari

    Aspirin in Primary Prevention of Stroke-Review of Evidence Through the Needs of Indian Clinical Settings

    Aspirin in Primary Prevention of Stroke-Review of Evidence Through the Needs of Indian Clinical...

    Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

    Dapagliflozin Shines in Post-TAVI Patients:DAPA-TAVI Trial Findings

    Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension, Dyslipidemia, and Familial ASCVD Risk

    Identifying Candidates for Aspirin in Primary Prevention: Men Aged 40-50 with Hypertension,...

    Featured image representing thinking

    Is Pharma Marketing Going Through "Thinking Recession"?

    View All

    Journal Club Today

    Micro labs to offer mucolytic solution for respiratory care with its recently launched Pulmucus range

    Micro labs to offer mucolytic solution for respiratory care with its recently launched Pulmucus...

    View All

    Health News Today

    Health Bulletin 9/July/ 2025

    Health Bulletin 9/July/ 2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok