Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Novavax COVID-19 vaccine wins belated U.S. authorization

By Brian Buntz | July 13, 2022

NovavaxFirst announced in January 2020, Novavax’s (Nasdaq:NVAX) NVX-CoV2373 COVID–19 has won FDA authorization for primary immunization. However, it is presently not authorized as a booster.

NVAX shares ticked up 0.27% to $69.95.

Novavax is late to the COVID-19 vaccine partner, scoring authorization more than a year and a half after Moderna (NYSE:MRNA) and Pfizer (NYSE:PFE) won emergency use authorization for their respective COVID-19 vaccines.

Gaithersburg, Maryland–based Novavax had received a $1.75 billion federal contract to develop and manufacture NVX-CoV2373.

In August, the federal government said it would not provide money for further production until Novavax addressed quality concerns.

Now that the vaccine is authorized, CDC will convene an advisory panel to advise who should obtain the two-dose vaccine.

Before the omicron and delta waves, the Novavax vaccine was 90.4% efficacious in preventing COVID-19 of any severity in. Phase 3 trial. There were no cases of moderate or severe COVID-19 in those who received the vaccine.

Before authorizing the Novavax vaccine, FDA regulators had pondered whether the vaccine could pose a risk of myocarditis. The vaccine will carry a warning that the vaccine may have a small risk of myocarditis or pericarditis.

The federal government recently ordered 3.2 million doses of the NVX-CoV2373 vaccine.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Dr. Robert M. Califf in a news release. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Similar to the Pfizer-BioNTech vaccine, the vaccine is administered 21 days apart.

In December, Novavax won marketing authorization in Europe for the vaccine. In Europe, 12.6 million Novavax vaccine doses have been distributed since then.

According to a survey from Morning Consult, 77% of unvaccinated adults didn’t plan on obtaining Novavax’s protein-based COVID-19 vaccine.


Filed Under: Infectious Disease
Tagged With: Novavax, NVX-CoV2373
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Secretary of Health removes all current members of the CDC advisory committee on immunization practices
covid-19 vaccine
FDA COVID booster pullback jolts vaccine stocks before gains cool
Coronavirus Covid-19 background - 3d rendering
Pregnancy associated with less long COVID: Researchers call for studies on protective biology
How technology advances are helping scientists unlock the mysteries of zoonotic diseases
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

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.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 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
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE