Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA advisory panel backs Moderna COVID-19 vaccine

By Brian Buntz | December 17, 2020

Moderna

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

A week after supporting the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), an FDA advisory committee endorsed the mRNA-1273 vaccine from Moderna (NSDQ:MRNA). A total of 20 panel members voted in favor of the vaccine, and one member abstained. 

After releasing an upbeat assessment of the vaccine earlier this week, FDA is likely to grant emergency use authorization of the vaccine on Friday for adults 18 and older. 

FDA has notified Moderna “that it will rapidly work toward finalization and issuance of an emergency use authorization,” according to FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the two said in a statement.

The Moderna vaccine has less-stringent storage requirements than the Pfizer vaccine. It is stable up to 30 days when held at a refrigerator temperature of 2–8°C. By contrast, the Pfizer vaccine must be generally held between –80 and –60 °C and shielded from light before it is ready to use. 

The vaccine can also be shipped in smaller batches than the Pfizer vaccine, making it easier to distribute in rural areas.  

Earlier this year, Moderna committed to shipping 20 million vaccine doses by the end of 2020 and 500 million to 1 billion doses in 2021. 

The vaccine received a single abstention because Dr. Michael Kurilla, the director of clinical innovation at the National Center for Advancing Translational Sciences, had a “serious reservations” about the broad recommendation to give the vaccine to adults 18 or older. That statement could sound like “full approval” under a Biologics License Application. “Many of the media reports from last week and this week talk about this panel’ approving this vaccine’ or ‘recommending this vaccine for approval,’” he said. “We even heard today during the open public hearing session several medical professionals talking about ‘approving’ [the vaccine].”   

“A blanket statement for individuals 18 years and older is far too broad,” Kurilla said, adding he would have felt more comfortable if the question referred to mRNA-1273 as an “experimental” vaccine. 

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, took issue with that conclusion. “You can’t qualify things as being experimental because you can always say that about any medical product,” he said. “When the HPV vaccine came out, we could say: ‘Well, we think that it’s OK seven years because that’s what we have data for.”  

Gen. Gustave Perna, who is overseeing the Operation Warp Speed effort to distribute COVID-19 vaccines, expects to ship 6 million doses of the Moderna vaccine in the week following EUA.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: clinical trials, coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccine trial, Moderna
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Tiffany Hurd
CB Therapeutics biz dev lead sees upside for psychedelics in mental health and beyond
Pharmacovigilance
A new era of pharmacovigilance: Worldwide master key for drug safety monitoring
Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50